Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol

Elizabeth O Bodunde; Daire Buckley; Eimear O'Neill; Gillian M. Maher; Karen Matvienko-Sikar; Karen O'Connor; Fergus P. McCarthy; Ali S. Khashan

doi:10.12688/hrbopenres.13660.2

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Study Protocol

Revised

Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol

[version 2; peer review: 1 approved, 1 approved with reservations]

Elizabeth O Bodunde^1,2, Daire Buckley², Eimear O'Neill³, [...] Gillian M. Maher^1,2, Karen Matvienko-Sikar¹, Karen O'Connor^4,5, Fergus P. McCarthy^2,6, Ali S. Khashan^1,2

Elizabeth O Bodunde^1,2, Daire Buckley², [...] Eimear O'Neill³, Gillian M. Maher^1,2, Karen Matvienko-Sikar¹, Karen O'Connor^4,5, Fergus P. McCarthy^2,6, Ali S. Khashan^1,2

PUBLISHED 24 Apr 2023

Author details Author details

¹ School of Public Health, University College Cork, Cork, Ireland
² INFANT Research Centre, University College Cork, Cork, Ireland
³ Perinatal Mental Health, AMHS and CAMHS, University College Cork, Cork, Ireland
⁴ RISE, Early Intervention in Psychosis Team, South Lee Mental Health Services, Cork, Ireland
⁵ Department of Psychiatry and Neurobehavioral Science, University College Cork, Cork, Ireland
⁶ Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Cork, Ireland

Elizabeth O Bodunde
Roles: Conceptualization, Investigation, Methodology, Visualization, Writing – Original Draft Preparation

Daire Buckley
Roles: Validation, Writing – Review & Editing

Eimear O'Neill
Roles: Validation, Writing – Review & Editing

Gillian M. Maher
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Karen Matvienko-Sikar
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Karen O'Connor
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Fergus P. McCarthy
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Ali S. Khashan
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Maternal and Child Health collection.

Abstract

Background: Existing studies have established an association between pregnancy, birth complications, and mental health in the first few weeks postpartum. However, there is no clear understanding of whether pregnancy and birth complications increase the risk of adverse maternal mental outcomes in the longer term. Research on maternal adverse mental health outcomes following pregnancy and birth complications beyond 12 months postpartum is scarce, and findings are inconsistent.

Objective: This systematic review and meta-analysis will examine the available evidence on the association between pregnancy and birth complications and long-term adverse maternal mental health outcomes.

Methods and analysis: We will include cohort, cross-sectional, and case-control studies in which a diagnosis of pregnancy and/or birth complication (preeclampsia, pregnancy loss, caesarean section, preterm birth, perineal laceration, neonatal intensive care unit admission, major obstetric haemorrhage, and birth injury/trauma) was reported and maternal mental disorders (depression, anxiety disorders, bipolar disorders, psychosis, and schizophrenia) after 12 months postpartum were the outcomes. A systematic search of PubMed, Embase, CINAHL, PsycINFO, and Web of Science will be conducted following a detailed search strategy until August 2022. Three authors will independently review titles and abstracts of all eligible studies, extract data using pre-defined standardised data extraction and assess the quality of each study using the Newcastle-Ottawa Scale. We will use random-effects meta-analysis for each exposure and outcome variable to calculate overall pooled estimates using the generic inverse variance method. This systematic review will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.

Ethical consideration: The proposed systematic review and meta-analysis is based on published data; ethics approval is not required. The results will be presented at scientific meetings and publish in a peer-reviewed journal.
PROSPERO registration: CRD42022359017

Keywords

Pregnancy, birth, complications, long-term, adverse mental health outcome

Corresponding author: Elizabeth O Bodunde

Competing interests: No competing interests were disclosed.

Grant information: HRB (SPHeRE-2018-1).
The funders had no role in the study design, data collection, and analysis, decision to publish, and manuscript preparation.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2023 Bodunde EO et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Bodunde EO, Buckley D, O'Neill E et al. Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol [version 2; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:3 (https://doi.org/10.12688/hrbopenres.13660.2) First published: 10 Jan 2023, 6:3 (https://doi.org/10.12688/hrbopenres.13660.1) Latest published: 24 Oct 2023, 6:3 (https://doi.org/10.12688/hrbopenres.13660.3)

Revised Amendments from Version 1

Following suggestions from the reviewer, we have amended the manuscript to address their comments
Throughout the manuscripts, we have adjusted the phrasing of "preterm delivery" to "preterm birth". In the first paragraph, we have provided clarity on the global prevalence of prevalence and birth complications as reported by the World Health Organisation. We have also included a statement in the PICO criteria to be more specific on what we defined as pregnancy and birth complications in this review. We have clarified in the exclusion criteria that the outcomes of interest in this review are new mental disorders diagnosed 12 months postpartum. We have provided more information on the limitation of the study on how we would address studies where specific exposures cannot be determined. Data is now referred to in the plural tense.

See the authors' detailed response to the review by Christina Kang-Yi
See the authors' detailed response to the review by David Ellwood

Introduction

Pregnancy and childbirth complications are known to cause substantial morbidity and psychological distress in mothers^1,2. Preterm birth, preeclampsia, preterm labour, prenatal haemorrhage, and gestational hypertension are among the significant pregnancy problems and results in maternal and neonatal morbidity and mortality^3,4. According to the World Health Organization, in 15% of all pregnancies, a spectrum of pregnancy and birth complications may occur⁵. Every year more than one and a half million women suffer from pregnancy-related complications during pregnancy and birth⁶. Association between obstetric complications and chronic psychiatric and medical conditions in later life is becoming recognised⁷. It has been established that these complications can lead to the emergence of stress and trauma, both of which can affect a woman’s mental state⁸.

Several studies have explored short-term maternal mental health problems following pregnancy and birth complications with a focus on maternal postpartum stress^9,10. Pregnancy and birth are potential triggers for new psychiatric illness, particularly after unexpected events, caesarean sections, miscarriages and, perception of negative or traumatic birth¹¹. Preterm birth is associated with an increased risk for depression, anxiety, and stress in the immediate postpartum period^12–14. Other studies reported that spontaneous abortion and miscarriage during pregnancy puts women at higher risk for posttraumatic stress disorder (PTSD) and bipolar disorder at six to eight weeks postpartum^15,16. Some studies suggested that having preeclampsia comorbidities resulted in the highest risk of psychiatric episodes^17,18. A Nigerian study reported independent factors such as hospital admission, emergency caesarean section, and the poor maternal experience of control during childbirth to be associated with PTSD at six weeks postpartum¹⁹. Several systematic reviews and meta-analyses have also suggested that adverse pregnancy and birth outcomes such as preeclampsia, preterm birth, and mode of delivery were risk factors for postpartum mental disorders^20–22.

Neiger et al. 2017, reported that these obstetrical problems continue to impact on maternal health years after the index pregnancy²³. Postpartum stress and depression have frequently been investigated, and predictors that have been most associated are pre-existing psychiatric comorbidities, stress levels in pregnancy, and poor social support¹¹. Only a small number of studies have reported on maternal mental outcomes after pregnancy and birth complications, and most are restricted to the first few months of life^24–27. Two studies with an average of seven years of follow-up showed inconsistent findings; when compared to a control group, Gaugler-Senden et al. reported PTSD symptoms in women who experienced early preeclampsia but no difference in depression and anxiety. Whereas Postma et al. found that women with early preeclampsia reported higher depressive and anxiety symptoms^28,29.

Despite the psychological implications of adverse pregnancy and birth complications, the plausibility of associations with long-term adverse maternal mental health outcomes is yet to be systematically evaluated in existing literature, highlighting the need for further study in this area. Examining the association between pregnancy and birth complications and mental outcomes beyond the immediate postpartum period is an essential contribution to obstetric care and public health. The findings of this review will provide an overview of the current state of knowledge regarding whether having a complicated pregnancy or birth is a separate risk factor for adverse maternal mental health outcomes beyond the first year following childbirth. Therefore, this systematic review aims to synthesize the available evidence assessing the association between pregnancy and childbirth complications and long-term adverse maternal mental health outcomes.

Review question

Do pregnancy and birth complications increase the risk of adverse maternal mental health outcomes after 12 months postpartum?

Methods

The following PICO requirements will guide this systematic review.

Population

Women who have had at least one pregnancy.

Exposures

We will consider any of the following pregnancy and birth complication as exposures of interest: preeclampsia, pregnancy loss (miscarriage, stillbirth, and spontaneous abortion), caesarean section (elective, and emergency), preterm birth (defined as birth <37 weeks gestation), third/fourth perineal laceration, neonatal intensive care unit (NICU) admission >72 hours, major obstetric haemorrhage, birth injury/trauma. It should be noted that some of these complications such as elective caesarean section maybe at the request of the pregnant women and therefore may not be considered a complication. We plan to have a separate meta-analysis for each complication as we explained later.

Comparison

Women who never had corresponding pregnancy and birth complications. For instance, we will compare women who experienced an emergency caesarean section to those who never experienced an emergency caesarean section.

Outcomes

Any of the following adverse maternal mental health outcomes diagnosed or reported after the first year following childbirth will be considered an outcome of interest.

Primary outcomes: anxiety disorder, bipolar disorders, depression, schizophrenia, psychosis, and posttraumatic stress disorder.

Other outcomes: obsessive-compulsive disorder, panic disorder, agoraphobia, social phobia, acute stress disorder, delusional disorder, eating disorder, somatisation disorder, body dysmorphic disorder, conversion disorder, and substance-related disorder.

Protocol and registration

This study adheres to the guidelines in the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P) statement³⁰. Under the guidelines, this systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 11 September 2022 with registration number CRD42022359017.

Search strategy

1. One reviewer (E.O.B) will systematically search the literature in the following electronic databases: PubMed, CINAHL, EMBASE, PsycINFO and Web of Science, including all years from the inception of the electronic databases until August 2022. A detailed search strategy has been compiled and these terms will be searched according to the principles of Boolean Logic (AND, OR NOT) and using Medical Subject Headings (MeSH). The search strategy is included in the Extended data³¹.

2. The reference lists of the included studies will be manually searched to find additional potentially eligible research as a supplement to the electronic database searches.

Criteria for considering studies for the review

Inclusion criteria

Cohort, case-control, and cross-sectional studies in which a complication of pregnancy or childbirth was reported, and maternal mental health beyond the first year following childbirth is the outcome of interest.
Data must be from an original study. If more than one study were based on the same dataset, the study with the longest follow-up period will be included. We may perform sensitivity analyses for different scenarios. Such analyses will be highlighted as post-hoc.
A complication of pregnancy or childbirth and maternal mental health may be confirmed through medical records, doctor-diagnosed self-reporting, or validated questionnaires.
We will include studies published in English only.
Peer-reviewed literature only will be included.

Exclusion criteria

Systematic reviews, case reports, case series, letters, commentaries, notes, editorials, conference abstracts and dissertations.
Studies that are not published in English.
Studies on women with a pre-existing mental illness or mental illnesses prior to 12 months postpartum.
Animal studies.

Selection of studies for inclusion in the review

Titles and abstracts of studies retrieved from each database search will be stored and managed in the EndNote reference manager and de-duplicated. Three review authors (E.O.B, E.O and D.B) will independently review the titles and abstracts of the studies. Full texts will be obtained where necessary to screen for eligibility in the systematic review and meta-analysis following the pre-defined inclusion/exclusion criteria. Where consensus on eligibility cannot be achieved, a fourth review author (A.S.K) will be involved in the discussion to reach a consensus. In the case of an eligible study, where more data is needed, the corresponding author will be contacted via email. If the corresponding author does not reply, a reminder will be sent two weeks later.

Data extraction and management

Three reviewers (E.O.B, E.O, and D.B) will independently extract data from the eligible studies using a standardised data extraction form. We will extract data including the author and year of publication, study design, country and setting of study, sample size, definition or assessment of the exposures and outcome(s) of interest, comparison group, length of follow up, confounders adjusted for (if any), crude and adjusted estimates. Where necessary, we will contact corresponding authors of published studies to obtain relevant information about effect estimates. Discrepancies will be discussed between reviewers and where necessary, a fourth reviewer (A.S.K) will be consulted to achieve a consensus.

Quality appraisal of included studies

Quality assessment of the included studies will be conducted by three reviewers (E.O.B, E.O, and D.B) independently and agreed upon subsequently using the Newcastle Ottawa Scale³². This scale uses a “star system,” in which stars are assigned to show the quality of studies based on the following three criteria: selection of the study groups, comparability of the groups, and the ascertainment of the exposure and outcome of interest (the total score ranged from 0–9). We will consider 0 to 3 stars low quality, 4 to 6 stars moderate quality, and 7 to 9 stars high quality. The overall likelihood of bias will be assessed and reported for each study. Discrepancies will be discussed between reviewers and where necessary, a fourth reviewer (A.S.K) will be consulted.

Data synthesis, including assessment of heterogeneity

We will undertake separate meta-analyses for each exposure-outcome association. Random effects meta-analyses will be performed to calculate overall pooled estimates where data allow. For example, for preeclampsia as an exposure of interest, a meta-analysis will be undertaken to investigate the association between (1) preeclampsia and anxiety disorders, (2) preeclampsia and bipolar disorders, (3) preeclampsia and schizophrenia. We will repeat this for all exposures. The generic inverse variance method will be used to display crude and adjusted results where possible. We will base the adjustment on the definition outlined in each identified study. We will also perform the following subgroup/sensitivity analyses where the data allow, using RevMan 5.4:

1) According to study design (cohort vs case-control vs cross-sectional).
2) According to the study quality (minimal/low versus moderate/high).
3) According to the measurement of outcome data (medical records versus doctor-diagnosed self-reported versus validated questionnaires).
4) According to the length of follow-up.

Publication bias will be assessed using a funnel plot, provided at least 10 or more studies are included in the meta-analysis. Where any other subgroup/sensitivity analyses are identified in the meta-analysis, such as analyses to explore potential high heterogeneity, these will be clearly labelled as post-hoc analyses.

Presenting and reporting the results

A PRISMA flow diagram will be included to outline the step-by-step study selection process, and a rationale provided for excluded studies at full-text screening. The characteristics and quality assessment of the included studies will be presented in tables, and pooled estimates will be presented using forest plots. If raw data cannot be obtained for inclusion in meta-analyses, the findings will be included individually in a separate table. Where data is unsuitable for meta-analysis, study findings will be narratively synthesized and presented in tables.

Conclusions

This systematic review and meta-analysis will summarise the existing literature examining the association between pregnancy and birth complications and long-term adverse maternal mental outcomes based on a prespecified study protocol. The high prevalence of pregnancy and birth complications suggests that any potential association would have important public health implications.

Potential strengths and limitations of this study

The strength of this systematic review and meta-analysis includes providing updated knowledge on the associations between common pregnancy and birth complications and the risk of adverse maternal mental health outcomes in the long term. The use of a comprehensive search strategy, a prospectively registered protocol, and adherence to the PRISMA guidelines are further strengths of this review. In addition, three reviewers will screen for study eligibility and perform data extraction and quality appraisal of included studies, minimising the likelihood of reviewer-based bias in the systematic review.

We anticipate that publication bias may be a limitation in this review. Studies that show an effect have an increased likelihood of being published and published in English. Due to limited resources, the systematic review search will be confined to studies published in the English language only, potentially resulting in publication bias and relevant indexed studies being overlooked. Some studies may report more than one complication as an exposure, where exposure cannot be determined, we will narratively synthesize results and provide summary of results. If possible, a funnel plot will be used to assess the presence of publication bias. Furthermore, the presence of confounding is a major concern in observational studies. Potential confounders may include the family’s socio-economic status, maternal age, parity, body mass index (BMI), maternal smoking, and alcohol status during pregnancy. As mentioned above, our meta-analyses will display both crude and adjusted results where possible using the generic inverse variance method, basing adjustment on the definition outlined in each identified study.

Ethics and dissemination

Given that this is a protocol for a systematic review based on published data, there is no requirement for ethics approval. It is anticipated that findings will be disseminated through publication in a peer-reviewed journal and conference presentations.

Data availability

Underlying data

No data are associated with this article.

Extended data

Figshare: Search strategy- Pregnancy and birth complications and long-term adverse maternal mental outcomes: a systematic review and meta-analysis protocol,

https://doi.org/10.6084/m9.figshare.21572304³¹

Reporting guidelines

Figshare: Preferred Reporting Items for Systematic review and Meta-analysis protocol (PRISMA-P) checklist and flow diagram.

https://doi.org/10.6084/m9.figshare.21568716³⁰

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Author roles

Investigation, Methodology, Visualization, Writing, & Original Draft Preparation – Elizabeth O. Bodunde.

Writing; review & editing, Validation - Eimear O’Neill, Daire Buckley.

Conceptualization, Methodology, Supervision, Writing; review & editing –Gillian M. Maher, Karen Matvienko-Sikar, Karen O’Connor, Fergus P. McCarthy, Ali S. Khashan.

Faculty Opinions recommended

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Version 3

VERSION 3 PUBLISHED 10 Jan 2023

Author details Author details

Elizabeth O Bodunde
Roles: Conceptualization, Investigation, Methodology, Visualization, Writing – Original Draft Preparation

Daire Buckley
Roles: Validation, Writing – Review & Editing

Eimear O'Neill
Roles: Validation, Writing – Review & Editing

Gillian M. Maher
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Karen Matvienko-Sikar
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Karen O'Connor
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Fergus P. McCarthy
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Ali S. Khashan
Roles: Conceptualization, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

HRB (SPHeRE-2018-1).
The funders had no role in the study design, data collection, and analysis, decision to publish, and manuscript preparation.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (3)

version 3

Revised

Published: 24 Oct 2023, 6:3

https://doi.org/10.12688/hrbopenres.13660.3

version 2

Revised

Published: 24 Apr 2023, 6:3

https://doi.org/10.12688/hrbopenres.13660.2

version 1

Published: 10 Jan 2023, 6:3

https://doi.org/10.12688/hrbopenres.13660.1

© 2023 Bodunde EO et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Bodunde EO, Buckley D, O'Neill E et al. Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol [version 2; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2023, 6:3 (https://doi.org/10.12688/hrbopenres.13660.2)

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Open Peer Review

Version 2

VERSION 2

PUBLISHED 24 Apr 2023

Revised

Views

Reviewer Report 07 Sep 2023

Christina Kang-Yi, Rutgers Biomedical and Health Sciences, New Jersy, USA

Approved with Reservations

https://doi.org/10.21956/hrbopenres.15021.r35380

The study aims to synthesize the available evidence of association between pregnancy and childbirth complications and long-term adverse maternal mental health outcomes by systematically reviewing published observational studies including cohort, case-control, and cross-sectional studies. Given the limited information on maternal mental health outcomes resulted in by pregnancy and childbirth complications, the systematic review has potential to contribute to improving preventive maternal mental health.

The major challenge in achieving the aim of the systematic review is identifying increased risk of mental health disorders 12 months after pregnancy and childbirth complications by reviewing observational studies that used medical records. Mental Health diagnoses identified through medical records do not reflect the exact onset of mental disorders for women with delayed help seeking and treatment. Thus, definitions of onset of mental health disorders identified through medical records will be arbitrary and can lead to inaccurate detection of mental health disorders 12 months after pregnancy and childbirth complications. Additionally, mental health diagnoses identified through administrative data such as health claims usually include a lag time. Lastly, studies based on using medical records will include a limitation of not knowing pre-existing mental health disorders, unless the studies retrospectively observe multiple years of data on mental health diagnoses prior to pregnancy. Please elaborate how you will handle the difficulties of identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications, given these limitations of observational studies using medical records.

There are other factors (other than the confounders authors listed in the protocol) that are associated with postpartum mental health disorders. For example, maternal self-efficacy, support by the partner, breastfeeding, a negative experience of the first week postpartum, and poor current health of the mother have been identified as significant factors associated with developing postpartum depression and/or anxiety. Refer to the following reference:

van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., Groothuis-Oudshoorn, C. G. M., & Reijneveld, S. A. (2021). Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy. Journal of Affective Disorders, 286, 158-165. https://doi.org/10.1016/j.jad.2021.02.062

If there is not a sufficient number of studies published on each pregnancy and childbirth complication outcome, conducting meta-analysis for each outcome, adjusting for the confounding factors identified in the literature, is not feasible. Please elaborate how you will handle this.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, Reijneveld SA: Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy.J Affect Disord. 2021; 286: 158-165 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Mental health services research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 17 Nov 2023

Elizabeth Bodunde, University College Cork, Ireland

17 Nov 2023

Author Response

Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and ... Continue reading Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and have responded to below.
We have incorporated suggestions into the protocol for clarity.

Reviewer comment 1
The major challenge in achieving the aim of the systematic review is identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications by reviewing observational studies that used medical records. Mental Health diagnoses identified through medical records do not reflect the exact onset of mental disorders for women with delayed help-seeking and treatment. Thus, definitions of the onset of mental health disorders identified through medical records will be arbitrary and can lead to inaccurate detection of mental health disorders 12 months after pregnancy and childbirth complications. Additionally, mental health diagnoses identified through administrative data such as health claims usually include a lag time. Lastly, studies based on using medical records will include a limitation of not knowing pre-existing mental health disorders, unless the studies retrospectively observe multiple years of data on mental health diagnoses prior to pregnancy. Please elaborate on how you will handle the difficulties of identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications, given these limitations of observational studies using medical records.

Author Response 1
We acknowledge that using observational studies/administrative data in mental health epidemiology has its limitations. The ability of such data to pinpoint the onset of mental health illnesses is constrained (if this is not distinguished from the date of diagnosis). Yes, this can be a problem with insurance claims data as well which is only one type of data, we have also included papers that described mental health illness that were both self-reported and physician-diagnosed using questionnaires. By including multiple types and approaches to diagnoses in this review, it is possible to examine the potential differences between the diagnostic approaches and their limitations. We have now acknowledged this in our study’s limitations as follows.

“We acknowledge that there are limitations with this review. The use of administrative health data may not accurately reflect an increased risk for mental health disorders beyond 12 months postpartum. As a result, we also included papers that described mental health problems that were both self-reported and physician-diagnosed using validated questionnaires”.

Reviewer comment 2
There are other factors (other than the confounders authors listed in the protocol) that are associated with postpartum mental health disorders. For example, maternal self-efficacy, support by the partner, breastfeeding, a negative experience of the first week postpartum, and poor current health of the mother have been identified as significant factors associated with developing postpartum depression and/or anxiety. Refer to the following reference: van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., Groothuis-Oudshoorn, C. G. M., & Reijneveld, S. A. (2021). Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy. Journal of Affective Disorders, 286,158-165. https://doi.org/10.1016/j.jad.2021.02.062

Author Response 2
Thank you for bringing the van der Zee-van den Berg et al study to our attention. We acknowledge that there are multiple factors associated with postpartum mental health disorders other than the examples listed in the protocol. We have incorporated this into our protocol as follows and have referenced the van der Zee-van den Berg et al study as follows.
“Potential confounders that may be associated with postpartum mental health disorders include adverse life events, first parity, family’s socio-economic status, maternal age, body mass index (BMI), maternal smoking, alcohol, and substance use, preexisting mental health disorders, social support, maternal self-efficacy, co-morbidities/longstanding illness, ethnicity, employment-related factors, poor current health, breastfeeding, and child’s health problem¹”.

Reviewer comment 3
If there is not a sufficient number of studies published on each pregnancy and childbirth complication outcome, conducting a meta-analysis for each outcome, the adjusting for the confounding factors identified in the literature, is not feasible. Please elaborate on how you will handle this.

Author Response 3
Yes, there is a possibility there will be a small number of studies on certain pregnancy and birth complications as well as mental health outcomes that have not received much attention in the literature. In instances where a meta-analysis cannot be conducted for this reason, a narrative synthesis will be conducted with results also presented descriptively in a table. The study protocol has been updated to reflect this as follows.
“For specific exposure-outcomes association, there may not be enough studies to conduct a meta-analysis. In such an instance, we will conduct a narrative synthesis and present results descriptively in a table.

Thank you for the positive comments in relation to the concept and rationale of this systematic review.
Yours Sincerely,
Ms. Elizabeth Bodunde, Ms. Daire Buckley, Dr. Eimear O’Neill, Dr. Gillian Maher, Dr. Karen O’Connor, Dr. Fergus McCarthy, Dr. Karen Matvienko-Sikar, Dr. Ali Khashan.

References
1. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, Reijneveld SA. Postpartum depression and anxiety: a community-based study on risk factors before, during, and after pregnancy. J Affect Disord [Internet]. 2021 May 1 [cited 2023 Oct 11];286:158–65. Available from: https://pubmed.ncbi.nlm.nih.gov/33725615/

Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and have responded to below.
We have incorporated suggestions into the protocol for clarity.

Reviewer comment 1
The major challenge in achieving the aim of the systematic review is identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications by reviewing observational studies that used medical records. Mental Health diagnoses identified through medical records do not reflect the exact onset of mental disorders for women with delayed help-seeking and treatment. Thus, definitions of the onset of mental health disorders identified through medical records will be arbitrary and can lead to inaccurate detection of mental health disorders 12 months after pregnancy and childbirth complications. Additionally, mental health diagnoses identified through administrative data such as health claims usually include a lag time. Lastly, studies based on using medical records will include a limitation of not knowing pre-existing mental health disorders, unless the studies retrospectively observe multiple years of data on mental health diagnoses prior to pregnancy. Please elaborate on how you will handle the difficulties of identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications, given these limitations of observational studies using medical records.

Author Response 1
We acknowledge that using observational studies/administrative data in mental health epidemiology has its limitations. The ability of such data to pinpoint the onset of mental health illnesses is constrained (if this is not distinguished from the date of diagnosis). Yes, this can be a problem with insurance claims data as well which is only one type of data, we have also included papers that described mental health illness that were both self-reported and physician-diagnosed using questionnaires. By including multiple types and approaches to diagnoses in this review, it is possible to examine the potential differences between the diagnostic approaches and their limitations. We have now acknowledged this in our study’s limitations as follows.

“We acknowledge that there are limitations with this review. The use of administrative health data may not accurately reflect an increased risk for mental health disorders beyond 12 months postpartum. As a result, we also included papers that described mental health problems that were both self-reported and physician-diagnosed using validated questionnaires”.

Reviewer comment 2
There are other factors (other than the confounders authors listed in the protocol) that are associated with postpartum mental health disorders. For example, maternal self-efficacy, support by the partner, breastfeeding, a negative experience of the first week postpartum, and poor current health of the mother have been identified as significant factors associated with developing postpartum depression and/or anxiety. Refer to the following reference: van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., Groothuis-Oudshoorn, C. G. M., & Reijneveld, S. A. (2021). Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy. Journal of Affective Disorders, 286,158-165. https://doi.org/10.1016/j.jad.2021.02.062

Author Response 2
Thank you for bringing the van der Zee-van den Berg et al study to our attention. We acknowledge that there are multiple factors associated with postpartum mental health disorders other than the examples listed in the protocol. We have incorporated this into our protocol as follows and have referenced the van der Zee-van den Berg et al study as follows.
“Potential confounders that may be associated with postpartum mental health disorders include adverse life events, first parity, family’s socio-economic status, maternal age, body mass index (BMI), maternal smoking, alcohol, and substance use, preexisting mental health disorders, social support, maternal self-efficacy, co-morbidities/longstanding illness, ethnicity, employment-related factors, poor current health, breastfeeding, and child’s health problem¹”.

Reviewer comment 3
If there is not a sufficient number of studies published on each pregnancy and childbirth complication outcome, conducting a meta-analysis for each outcome, the adjusting for the confounding factors identified in the literature, is not feasible. Please elaborate on how you will handle this.

Author Response 3
Yes, there is a possibility there will be a small number of studies on certain pregnancy and birth complications as well as mental health outcomes that have not received much attention in the literature. In instances where a meta-analysis cannot be conducted for this reason, a narrative synthesis will be conducted with results also presented descriptively in a table. The study protocol has been updated to reflect this as follows.
“For specific exposure-outcomes association, there may not be enough studies to conduct a meta-analysis. In such an instance, we will conduct a narrative synthesis and present results descriptively in a table.

Thank you for the positive comments in relation to the concept and rationale of this systematic review.
Yours Sincerely,
Ms. Elizabeth Bodunde, Ms. Daire Buckley, Dr. Eimear O’Neill, Dr. Gillian Maher, Dr. Karen O’Connor, Dr. Fergus McCarthy, Dr. Karen Matvienko-Sikar, Dr. Ali Khashan.

References
1. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, Reijneveld SA. Postpartum depression and anxiety: a community-based study on risk factors before, during, and after pregnancy. J Affect Disord [Internet]. 2021 May 1 [cited 2023 Oct 11];286:158–65. Available from: https://pubmed.ncbi.nlm.nih.gov/33725615/
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 17 Nov 2023

Elizabeth Bodunde, University College Cork, Ireland

17 Nov 2023

Author Response

Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and ... Continue reading Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and have responded to below.
We have incorporated suggestions into the protocol for clarity.

Reviewer comment 1
The major challenge in achieving the aim of the systematic review is identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications by reviewing observational studies that used medical records. Mental Health diagnoses identified through medical records do not reflect the exact onset of mental disorders for women with delayed help-seeking and treatment. Thus, definitions of the onset of mental health disorders identified through medical records will be arbitrary and can lead to inaccurate detection of mental health disorders 12 months after pregnancy and childbirth complications. Additionally, mental health diagnoses identified through administrative data such as health claims usually include a lag time. Lastly, studies based on using medical records will include a limitation of not knowing pre-existing mental health disorders, unless the studies retrospectively observe multiple years of data on mental health diagnoses prior to pregnancy. Please elaborate on how you will handle the difficulties of identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications, given these limitations of observational studies using medical records.

Author Response 1
We acknowledge that using observational studies/administrative data in mental health epidemiology has its limitations. The ability of such data to pinpoint the onset of mental health illnesses is constrained (if this is not distinguished from the date of diagnosis). Yes, this can be a problem with insurance claims data as well which is only one type of data, we have also included papers that described mental health illness that were both self-reported and physician-diagnosed using questionnaires. By including multiple types and approaches to diagnoses in this review, it is possible to examine the potential differences between the diagnostic approaches and their limitations. We have now acknowledged this in our study’s limitations as follows.

“We acknowledge that there are limitations with this review. The use of administrative health data may not accurately reflect an increased risk for mental health disorders beyond 12 months postpartum. As a result, we also included papers that described mental health problems that were both self-reported and physician-diagnosed using validated questionnaires”.

Reviewer comment 2
There are other factors (other than the confounders authors listed in the protocol) that are associated with postpartum mental health disorders. For example, maternal self-efficacy, support by the partner, breastfeeding, a negative experience of the first week postpartum, and poor current health of the mother have been identified as significant factors associated with developing postpartum depression and/or anxiety. Refer to the following reference: van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., Groothuis-Oudshoorn, C. G. M., & Reijneveld, S. A. (2021). Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy. Journal of Affective Disorders, 286,158-165. https://doi.org/10.1016/j.jad.2021.02.062

Author Response 2
Thank you for bringing the van der Zee-van den Berg et al study to our attention. We acknowledge that there are multiple factors associated with postpartum mental health disorders other than the examples listed in the protocol. We have incorporated this into our protocol as follows and have referenced the van der Zee-van den Berg et al study as follows.
“Potential confounders that may be associated with postpartum mental health disorders include adverse life events, first parity, family’s socio-economic status, maternal age, body mass index (BMI), maternal smoking, alcohol, and substance use, preexisting mental health disorders, social support, maternal self-efficacy, co-morbidities/longstanding illness, ethnicity, employment-related factors, poor current health, breastfeeding, and child’s health problem¹”.

Reviewer comment 3
If there is not a sufficient number of studies published on each pregnancy and childbirth complication outcome, conducting a meta-analysis for each outcome, the adjusting for the confounding factors identified in the literature, is not feasible. Please elaborate on how you will handle this.

Author Response 3
Yes, there is a possibility there will be a small number of studies on certain pregnancy and birth complications as well as mental health outcomes that have not received much attention in the literature. In instances where a meta-analysis cannot be conducted for this reason, a narrative synthesis will be conducted with results also presented descriptively in a table. The study protocol has been updated to reflect this as follows.
“For specific exposure-outcomes association, there may not be enough studies to conduct a meta-analysis. In such an instance, we will conduct a narrative synthesis and present results descriptively in a table.

Thank you for the positive comments in relation to the concept and rationale of this systematic review.
Yours Sincerely,
Ms. Elizabeth Bodunde, Ms. Daire Buckley, Dr. Eimear O’Neill, Dr. Gillian Maher, Dr. Karen O’Connor, Dr. Fergus McCarthy, Dr. Karen Matvienko-Sikar, Dr. Ali Khashan.

References
1. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, Reijneveld SA. Postpartum depression and anxiety: a community-based study on risk factors before, during, and after pregnancy. J Affect Disord [Internet]. 2021 May 1 [cited 2023 Oct 11];286:158–65. Available from: https://pubmed.ncbi.nlm.nih.gov/33725615/

Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and have responded to below.
We have incorporated suggestions into the protocol for clarity.

Reviewer comment 1
The major challenge in achieving the aim of the systematic review is identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications by reviewing observational studies that used medical records. Mental Health diagnoses identified through medical records do not reflect the exact onset of mental disorders for women with delayed help-seeking and treatment. Thus, definitions of the onset of mental health disorders identified through medical records will be arbitrary and can lead to inaccurate detection of mental health disorders 12 months after pregnancy and childbirth complications. Additionally, mental health diagnoses identified through administrative data such as health claims usually include a lag time. Lastly, studies based on using medical records will include a limitation of not knowing pre-existing mental health disorders, unless the studies retrospectively observe multiple years of data on mental health diagnoses prior to pregnancy. Please elaborate on how you will handle the difficulties of identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications, given these limitations of observational studies using medical records.

Author Response 1
We acknowledge that using observational studies/administrative data in mental health epidemiology has its limitations. The ability of such data to pinpoint the onset of mental health illnesses is constrained (if this is not distinguished from the date of diagnosis). Yes, this can be a problem with insurance claims data as well which is only one type of data, we have also included papers that described mental health illness that were both self-reported and physician-diagnosed using questionnaires. By including multiple types and approaches to diagnoses in this review, it is possible to examine the potential differences between the diagnostic approaches and their limitations. We have now acknowledged this in our study’s limitations as follows.

“We acknowledge that there are limitations with this review. The use of administrative health data may not accurately reflect an increased risk for mental health disorders beyond 12 months postpartum. As a result, we also included papers that described mental health problems that were both self-reported and physician-diagnosed using validated questionnaires”.

Reviewer comment 2
There are other factors (other than the confounders authors listed in the protocol) that are associated with postpartum mental health disorders. For example, maternal self-efficacy, support by the partner, breastfeeding, a negative experience of the first week postpartum, and poor current health of the mother have been identified as significant factors associated with developing postpartum depression and/or anxiety. Refer to the following reference: van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., Groothuis-Oudshoorn, C. G. M., & Reijneveld, S. A. (2021). Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy. Journal of Affective Disorders, 286,158-165. https://doi.org/10.1016/j.jad.2021.02.062

Author Response 2
Thank you for bringing the van der Zee-van den Berg et al study to our attention. We acknowledge that there are multiple factors associated with postpartum mental health disorders other than the examples listed in the protocol. We have incorporated this into our protocol as follows and have referenced the van der Zee-van den Berg et al study as follows.
“Potential confounders that may be associated with postpartum mental health disorders include adverse life events, first parity, family’s socio-economic status, maternal age, body mass index (BMI), maternal smoking, alcohol, and substance use, preexisting mental health disorders, social support, maternal self-efficacy, co-morbidities/longstanding illness, ethnicity, employment-related factors, poor current health, breastfeeding, and child’s health problem¹”.

Reviewer comment 3
If there is not a sufficient number of studies published on each pregnancy and childbirth complication outcome, conducting a meta-analysis for each outcome, the adjusting for the confounding factors identified in the literature, is not feasible. Please elaborate on how you will handle this.

Author Response 3
Yes, there is a possibility there will be a small number of studies on certain pregnancy and birth complications as well as mental health outcomes that have not received much attention in the literature. In instances where a meta-analysis cannot be conducted for this reason, a narrative synthesis will be conducted with results also presented descriptively in a table. The study protocol has been updated to reflect this as follows.
“For specific exposure-outcomes association, there may not be enough studies to conduct a meta-analysis. In such an instance, we will conduct a narrative synthesis and present results descriptively in a table.

Thank you for the positive comments in relation to the concept and rationale of this systematic review.
Yours Sincerely,
Ms. Elizabeth Bodunde, Ms. Daire Buckley, Dr. Eimear O’Neill, Dr. Gillian Maher, Dr. Karen O’Connor, Dr. Fergus McCarthy, Dr. Karen Matvienko-Sikar, Dr. Ali Khashan.

References
1. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, Reijneveld SA. Postpartum depression and anxiety: a community-based study on risk factors before, during, and after pregnancy. J Affect Disord [Internet]. 2021 May 1 [cited 2023 Oct 11];286:158–65. Available from: https://pubmed.ncbi.nlm.nih.gov/33725615/
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 03 May 2023

David Ellwood, School of Medicine and Dentistry, Gold Coast University Hospital, Griffith University, Gold Coast, Qld, Australia; Maternal-fetal Medicine, Gold Coast University Hospital, Gold Coast, Qld, Australia

Approved

https://doi.org/10.21956/hrbopenres.15021.r33663

I am happy with the responses of the authors to my previous comments, and ... Continue reading

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Version 1

VERSION 1

PUBLISHED 10 Jan 2023

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Reviewer Report 31 Jan 2023

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14938.r33322

This article is a proposal for a systematic review of the published scientific literature on pregnancy and birth complications and their association with long-term mental health outcomes. The stated aim is to look at each specified pregnancy complication, and each mental health outcome, and examine what support there is from the published literature for any association. The protocol is generally well-written, and uses an appropriate methodology. The research question is important, and I support their comments that this is an area that is under-researched and not well understood. I have four questions/comments that may help the authors in making some minor revisions to their protocol.

It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequela are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth, but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
The list of mental health conditions includes a number which are very common and for many women a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those in the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Clinical academic practice in obstetrics/maternal-fetal medicine, with extensive research interests in severe complications of pregnancy (especially perinatal death), and post-partum recovery including physical and emotional outcomes.

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Author Response 17 Nov 2023

Elizabeth Bodunde, University College Cork, Ireland

17 Nov 2023

Author Response

Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We ... Continue reading Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We have carefully considered the comments and have responded to each comment below.
We hope that our response has provided some clarity which will ultimately improve the quality of the manuscript.
Yours Sincerely,
Elizabeth Bodunde

This article is a proposal for a systematic review of the published scientific literature on pregnancy and birth complications and their association with long-term mental health outcomes. The stated aim is to look at each specified pregnancy complication, and each mental health outcome, and examine what support there is from the published literature for any association. The protocol is generally well-written and uses an appropriate methodology. The research question is important, and I support their comments that this is an area that is under-researched and not well understood. I have four questions/comments that may help the authors in making some minor revisions to their protocol.
Response: Thank you for the positive comment in relation to the concept and rationale of this systematic review.

Comment 1
It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequelae are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Response: Certainly, it is intriguing to talk about pregnancy and birth complications, particularly since they are described in various ways in the current literature. We have included a PICO to reflect what complications this review will focus on. We acknowledge that while some of these complications vary in their severity/normalness, we recognise that these aspects can be experienced differently by different people in different contexts/times. As such, the inclusion of these aspects together enables us to be very comprehensive, while still acknowledging differences. Because third- and fourth-degree perineal tears are more severe and devastating to women than first- and second-degree tears, which are typically encountered by primigravida women, we have only included third-and fourth-degree perineal tears. The study’s introduction and PICO criteria have been updated.

Comment 2
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
Response: Yes, we anticipate that co-morbidities will be a limitation in the meta-analyses particularly for studies that haven't made it explicit what pregnancy/birth complications are being looked at. If we are unable to identify the precise exposure, we will narratively synthesize these findings and leave them out of the meta-analyses. To account for this, the study’s limitations have been updated.

Comment 3
The list of mental health conditions includes a number that is very common and for many women, a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
Response: Only women who have received a new diagnosis of a mental health disorder after the first 12 months postpartum are of interest in this review. Women with pre-existing mental health issues during pregnancy or during the first year after giving birth will be excluded from the meta-analyses. This has been reflected in the exclusion criteria.

Comment 4
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those on the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.
Response: We agree that birth is a better description than the term ‘delivery’. The term delivery has been replaced with birth. We have revised the manuscript’s opening paragraph in the introduction.
Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We have carefully considered the comments and have responded to each comment below.
We hope that our response has provided some clarity which will ultimately improve the quality of the manuscript.
Yours Sincerely,
Elizabeth Bodunde

This article is a proposal for a systematic review of the published scientific literature on pregnancy and birth complications and their association with long-term mental health outcomes. The stated aim is to look at each specified pregnancy complication, and each mental health outcome, and examine what support there is from the published literature for any association. The protocol is generally well-written and uses an appropriate methodology. The research question is important, and I support their comments that this is an area that is under-researched and not well understood. I have four questions/comments that may help the authors in making some minor revisions to their protocol.
Response: Thank you for the positive comment in relation to the concept and rationale of this systematic review.

Comment 1
It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequelae are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Response: Certainly, it is intriguing to talk about pregnancy and birth complications, particularly since they are described in various ways in the current literature. We have included a PICO to reflect what complications this review will focus on. We acknowledge that while some of these complications vary in their severity/normalness, we recognise that these aspects can be experienced differently by different people in different contexts/times. As such, the inclusion of these aspects together enables us to be very comprehensive, while still acknowledging differences. Because third- and fourth-degree perineal tears are more severe and devastating to women than first- and second-degree tears, which are typically encountered by primigravida women, we have only included third-and fourth-degree perineal tears. The study’s introduction and PICO criteria have been updated.

Comment 2
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
Response: Yes, we anticipate that co-morbidities will be a limitation in the meta-analyses particularly for studies that haven't made it explicit what pregnancy/birth complications are being looked at. If we are unable to identify the precise exposure, we will narratively synthesize these findings and leave them out of the meta-analyses. To account for this, the study’s limitations have been updated.

Comment 3
The list of mental health conditions includes a number that is very common and for many women, a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
Response: Only women who have received a new diagnosis of a mental health disorder after the first 12 months postpartum are of interest in this review. Women with pre-existing mental health issues during pregnancy or during the first year after giving birth will be excluded from the meta-analyses. This has been reflected in the exclusion criteria.

Comment 4
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those on the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.
Response: We agree that birth is a better description than the term ‘delivery’. The term delivery has been replaced with birth. We have revised the manuscript’s opening paragraph in the introduction.
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 17 Nov 2023

Elizabeth Bodunde, University College Cork, Ireland

17 Nov 2023

Author Response

Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We ... Continue reading Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We have carefully considered the comments and have responded to each comment below.
We hope that our response has provided some clarity which will ultimately improve the quality of the manuscript.
Yours Sincerely,
Elizabeth Bodunde

This article is a proposal for a systematic review of the published scientific literature on pregnancy and birth complications and their association with long-term mental health outcomes. The stated aim is to look at each specified pregnancy complication, and each mental health outcome, and examine what support there is from the published literature for any association. The protocol is generally well-written and uses an appropriate methodology. The research question is important, and I support their comments that this is an area that is under-researched and not well understood. I have four questions/comments that may help the authors in making some minor revisions to their protocol.
Response: Thank you for the positive comment in relation to the concept and rationale of this systematic review.

Comment 1
It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequelae are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Response: Certainly, it is intriguing to talk about pregnancy and birth complications, particularly since they are described in various ways in the current literature. We have included a PICO to reflect what complications this review will focus on. We acknowledge that while some of these complications vary in their severity/normalness, we recognise that these aspects can be experienced differently by different people in different contexts/times. As such, the inclusion of these aspects together enables us to be very comprehensive, while still acknowledging differences. Because third- and fourth-degree perineal tears are more severe and devastating to women than first- and second-degree tears, which are typically encountered by primigravida women, we have only included third-and fourth-degree perineal tears. The study’s introduction and PICO criteria have been updated.

Comment 2
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
Response: Yes, we anticipate that co-morbidities will be a limitation in the meta-analyses particularly for studies that haven't made it explicit what pregnancy/birth complications are being looked at. If we are unable to identify the precise exposure, we will narratively synthesize these findings and leave them out of the meta-analyses. To account for this, the study’s limitations have been updated.

Comment 3
The list of mental health conditions includes a number that is very common and for many women, a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
Response: Only women who have received a new diagnosis of a mental health disorder after the first 12 months postpartum are of interest in this review. Women with pre-existing mental health issues during pregnancy or during the first year after giving birth will be excluded from the meta-analyses. This has been reflected in the exclusion criteria.

Comment 4
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those on the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.
Response: We agree that birth is a better description than the term ‘delivery’. The term delivery has been replaced with birth. We have revised the manuscript’s opening paragraph in the introduction.
Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We have carefully considered the comments and have responded to each comment below.
We hope that our response has provided some clarity which will ultimately improve the quality of the manuscript.
Yours Sincerely,
Elizabeth Bodunde

This article is a proposal for a systematic review of the published scientific literature on pregnancy and birth complications and their association with long-term mental health outcomes. The stated aim is to look at each specified pregnancy complication, and each mental health outcome, and examine what support there is from the published literature for any association. The protocol is generally well-written and uses an appropriate methodology. The research question is important, and I support their comments that this is an area that is under-researched and not well understood. I have four questions/comments that may help the authors in making some minor revisions to their protocol.
Response: Thank you for the positive comment in relation to the concept and rationale of this systematic review.

Comment 1
It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequelae are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Response: Certainly, it is intriguing to talk about pregnancy and birth complications, particularly since they are described in various ways in the current literature. We have included a PICO to reflect what complications this review will focus on. We acknowledge that while some of these complications vary in their severity/normalness, we recognise that these aspects can be experienced differently by different people in different contexts/times. As such, the inclusion of these aspects together enables us to be very comprehensive, while still acknowledging differences. Because third- and fourth-degree perineal tears are more severe and devastating to women than first- and second-degree tears, which are typically encountered by primigravida women, we have only included third-and fourth-degree perineal tears. The study’s introduction and PICO criteria have been updated.

Comment 2
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
Response: Yes, we anticipate that co-morbidities will be a limitation in the meta-analyses particularly for studies that haven't made it explicit what pregnancy/birth complications are being looked at. If we are unable to identify the precise exposure, we will narratively synthesize these findings and leave them out of the meta-analyses. To account for this, the study’s limitations have been updated.

Comment 3
The list of mental health conditions includes a number that is very common and for many women, a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
Response: Only women who have received a new diagnosis of a mental health disorder after the first 12 months postpartum are of interest in this review. Women with pre-existing mental health issues during pregnancy or during the first year after giving birth will be excluded from the meta-analyses. This has been reflected in the exclusion criteria.

Comment 4
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those on the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.
Response: We agree that birth is a better description than the term ‘delivery’. The term delivery has been replaced with birth. We have revised the manuscript’s opening paragraph in the introduction.
Competing Interests: No competing interests were disclosed. Close
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Version 3 (revision) 24 Oct 23		read
Version 2 (revision) 24 Apr 23	read	read
Version 1 10 Jan 23	read

David Ellwood, Griffith University, Gold Coast, Australia; Gold Coast University Hospital, Gold Coast, Australia
Christina Kang-Yi, Rutgers Biomedical and Health Sciences, New Jersy, USA

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09 Nov 2023 | for Version 3

Christina Kang-Yi, Rutgers Biomedical and Health Sciences, New Jersy, USA

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Approved

The authors addressed all my comments, and I have no further comments to make.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Mental health services research

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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43 Views

07 Sep 2023 | for Version 2

Christina Kang-Yi, Rutgers Biomedical and Health Sciences, New Jersy, USA

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Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Mental health services research

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Author Response

17 Nov 2023

Elizabeth Bodunde, University College Cork, Ireland

Dear Professor Christina Kang-Yi

Thank you for your review of our manuscript. We are grateful for your comments and suggestions on our manuscript which we have carefully considered and have responded to below.
We have incorporated suggestions into the protocol for clarity.

Reviewer comment 1
The major challenge in achieving the aim of the systematic review is identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications by reviewing observational studies that used medical records. Mental Health diagnoses identified through medical records do not reflect the exact onset of mental disorders for women with delayed help-seeking and treatment. Thus, definitions of the onset of mental health disorders identified through medical records will be arbitrary and can lead to inaccurate detection of mental health disorders 12 months after pregnancy and childbirth complications. Additionally, mental health diagnoses identified through administrative data such as health claims usually include a lag time. Lastly, studies based on using medical records will include a limitation of not knowing pre-existing mental health disorders, unless the studies retrospectively observe multiple years of data on mental health diagnoses prior to pregnancy. Please elaborate on how you will handle the difficulties of identifying the increased risk of mental health disorders 12 months after pregnancy and childbirth complications, given these limitations of observational studies using medical records.

Author Response 1
We acknowledge that using observational studies/administrative data in mental health epidemiology has its limitations. The ability of such data to pinpoint the onset of mental health illnesses is constrained (if this is not distinguished from the date of diagnosis). Yes, this can be a problem with insurance claims data as well which is only one type of data, we have also included papers that described mental health illness that were both self-reported and physician-diagnosed using questionnaires. By including multiple types and approaches to diagnoses in this review, it is possible to examine the potential differences between the diagnostic approaches and their limitations. We have now acknowledged this in our study’s limitations as follows.

“We acknowledge that there are limitations with this review. The use of administrative health data may not accurately reflect an increased risk for mental health disorders beyond 12 months postpartum. As a result, we also included papers that described mental health problems that were both self-reported and physician-diagnosed using validated questionnaires”.

Reviewer comment 2
There are other factors (other than the confounders authors listed in the protocol) that are associated with postpartum mental health disorders. For example, maternal self-efficacy, support by the partner, breastfeeding, a negative experience of the first week postpartum, and poor current health of the mother have been identified as significant factors associated with developing postpartum depression and/or anxiety. Refer to the following reference: van der Zee-van den Berg, A. I., Boere-Boonekamp, M. M., Groothuis-Oudshoorn, C. G. M., & Reijneveld, S. A. (2021). Postpartum depression and anxiety: a community-based study on risk factors before, during and after pregnancy. Journal of Affective Disorders, 286,158-165. https://doi.org/10.1016/j.jad.2021.02.062

Author Response 2
Thank you for bringing the van der Zee-van den Berg et al study to our attention. We acknowledge that there are multiple factors associated with postpartum mental health disorders other than the examples listed in the protocol. We have incorporated this into our protocol as follows and have referenced the van der Zee-van den Berg et al study as follows.
“Potential confounders that may be associated with postpartum mental health disorders include adverse life events, first parity, family’s socio-economic status, maternal age, body mass index (BMI), maternal smoking, alcohol, and substance use, preexisting mental health disorders, social support, maternal self-efficacy, co-morbidities/longstanding illness, ethnicity, employment-related factors, poor current health, breastfeeding, and child’s health problem¹”.

Reviewer comment 3
If there is not a sufficient number of studies published on each pregnancy and childbirth complication outcome, conducting a meta-analysis for each outcome, the adjusting for the confounding factors identified in the literature, is not feasible. Please elaborate on how you will handle this.

Author Response 3
Yes, there is a possibility there will be a small number of studies on certain pregnancy and birth complications as well as mental health outcomes that have not received much attention in the literature. In instances where a meta-analysis cannot be conducted for this reason, a narrative synthesis will be conducted with results also presented descriptively in a table. The study protocol has been updated to reflect this as follows.
“For specific exposure-outcomes association, there may not be enough studies to conduct a meta-analysis. In such an instance, we will conduct a narrative synthesis and present results descriptively in a table.

Thank you for the positive comments in relation to the concept and rationale of this systematic review.
Yours Sincerely,
Ms. Elizabeth Bodunde, Ms. Daire Buckley, Dr. Eimear O’Neill, Dr. Gillian Maher, Dr. Karen O’Connor, Dr. Fergus McCarthy, Dr. Karen Matvienko-Sikar, Dr. Ali Khashan.

References
1. van der Zee-van den Berg AI, Boere-Boonekamp MM, Groothuis-Oudshoorn CGM, Reijneveld SA. Postpartum depression and anxiety: a community-based study on risk factors before, during, and after pregnancy. J Affect Disord [Internet]. 2021 May 1 [cited 2023 Oct 11];286:158–65. Available from: https://pubmed.ncbi.nlm.nih.gov/33725615/

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29 Views

03 May 2023 | for Version 2

29 Views Cite this report Responses(0)

Approved

I am happy with the responses of the authors to my previous comments, and the resulting revisions to the manuscript and I have no further comments or questions.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Clinical academic practice in obstetrics/maternal-fetal medicine, with extensive research interests in severe complications of pregnancy (especially perinatal death), and post-partum recovery including physical and emotional outcomes.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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51 Views

31 Jan 2023 | for Version 1

51 Views Cite this report Responses(1)

Approved With Reservations

It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequela are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth, but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
The list of mental health conditions includes a number which are very common and for many women a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those in the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Respond to this report

Responses (1)

Author Response

17 Nov 2023

Elizabeth Bodunde, University College Cork, Ireland

Dear Professor Ellwood,
Thank you for agreeing to be part of the peer-review process for this manuscript. We are grateful for all your comments and suggestions on our manuscript. We have carefully considered the comments and have responded to each comment below.
We hope that our response has provided some clarity which will ultimately improve the quality of the manuscript.
Yours Sincerely,
Elizabeth Bodunde

This article is a proposal for a systematic review of the published scientific literature on pregnancy and birth complications and their association with long-term mental health outcomes. The stated aim is to look at each specified pregnancy complication, and each mental health outcome, and examine what support there is from the published literature for any association. The protocol is generally well-written and uses an appropriate methodology. The research question is important, and I support their comments that this is an area that is under-researched and not well understood. I have four questions/comments that may help the authors in making some minor revisions to their protocol.
Response: Thank you for the positive comment in relation to the concept and rationale of this systematic review.

Comment 1
It is always interesting to discuss what is a pregnancy and birth complication, and whether some of the very common sequelae are really complications or should be considered to be within the sphere of 'normal' outcomes. The list given includes some devastating outcomes such as stillbirth but also includes elective caesarean section (which for some women may not be considered a complication but the only rational option). Perineal tears can vary from minor to very severe with life-long consequences. Have you considered refining the list of complications to only include severe, unexpected maternal and/or perinatal outcomes of pregnancy and birth?
Response: Certainly, it is intriguing to talk about pregnancy and birth complications, particularly since they are described in various ways in the current literature. We have included a PICO to reflect what complications this review will focus on. We acknowledge that while some of these complications vary in their severity/normalness, we recognise that these aspects can be experienced differently by different people in different contexts/times. As such, the inclusion of these aspects together enables us to be very comprehensive, while still acknowledging differences. Because third- and fourth-degree perineal tears are more severe and devastating to women than first- and second-degree tears, which are typically encountered by primigravida women, we have only included third-and fourth-degree perineal tears. The study’s introduction and PICO criteria have been updated.

Comment 2
Many women in the reported studies will have experienced more than one complication. For example, someone with pre-eclampsia, who has an emergency caesarean section, and whose baby is admitted to the NICU for 2 weeks. This begs the question as to which complication was causative, or is it the combination that counts? How will you be able to deal with this issue in your meta-analysis?
Response: Yes, we anticipate that co-morbidities will be a limitation in the meta-analyses particularly for studies that haven't made it explicit what pregnancy/birth complications are being looked at. If we are unable to identify the precise exposure, we will narratively synthesize these findings and leave them out of the meta-analyses. To account for this, the study’s limitations have been updated.

Comment 3
The list of mental health conditions includes a number that is very common and for many women, a diagnosis will predate the first pregnancy. Are you only interested in women with a new diagnosis and no pre-existing mental health conditions?
Response: Only women who have received a new diagnosis of a mental health disorder after the first 12 months postpartum are of interest in this review. Women with pre-existing mental health issues during pregnancy or during the first year after giving birth will be excluded from the meta-analyses. This has been reflected in the exclusion criteria.

Comment 4
A few minor points are that data is a plural noun, and birth is a better description than the term 'delivery'. Also, I found the opening paragraph a bit contradictory. If only 5-15% of women experience a complication, but some of those on the list to be studied are much more common than that, it sounds like the study population is potentially a very large proportion of the birthing population.
Response: We agree that birth is a better description than the term ‘delivery’. The term delivery has been replaced with birth. We have revised the manuscript’s opening paragraph in the introduction.

View more View less

Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol

Abstract

Keywords

Revised Amendments from Version 1

Introduction

Review question

Methods

Population

Exposures

Comparison

Outcomes

Protocol and registration

Search strategy

Criteria for considering studies for the review

Selection of studies for inclusion in the review

Data extraction and management

Quality appraisal of included studies

Data synthesis, including assessment of heterogeneity

Presenting and reporting the results

Conclusions

Potential strengths and limitations of this study

Ethics and dissemination

Data availability

Underlying data

Extended data

Reporting guidelines

Author roles

References

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Pregnancy and birth complications associations with long-term adverse maternal mental health outcomes: a systematic review and meta-analysis protocol

Abstract

Keywords

Revised Amendments from Version 1

Introduction

Review question

Methods

Population

Exposures

Comparison

Outcomes

Protocol and registration

Search strategy

Criteria for considering studies for the review

Selection of studies for inclusion in the review

Data extraction and management

Quality appraisal of included studies

Data synthesis, including assessment of heterogeneity

Presenting and reporting the results

Conclusions

Potential strengths and limitations of this study

Ethics and dissemination

Data availability

Underlying data

Extended data

Reporting guidelines

Author roles

References

Comments on this article Comments (0)

Open Peer Review

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