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Published 2024 – 2025 | Version v2
Proposal Open

Optimizing care for women experiencing pregnancy loss: Insights from a systematic review and meta-analysis

Creators

  • 1. Government Erode Medical College and Hospital
  • 2. Department of Pharmacology

Contributors

  • 1. Government Erode Medical College and Hospital
  • 2. ROR icon Mid Yorkshire Hospitals NHS Trust
  • 3. Department of Obstetrics and Gynaecology
  • 4. ROR icon Government Vellore Medical College

Description

This PRISMA-P checklist outlines the protocol for the systematic review and meta-analysis titled "Optimizing Care for Women Experiencing Pregnancy Loss: Insights from a Systematic Review and Meta-Analysis." The study evaluates the effectiveness of pharmacological, psychological, and assisted reproductive technology (ART) interventions in improving clinical and psychological outcomes for women experiencing pregnancy loss, including miscarriage and recurrent pregnancy loss (RPL).

The checklist adheres to PRISMA-P guidelines, ensuring transparency and methodological rigor in the review process. It includes detailed information on the study objectives, eligibility criteria, data sources, search strategy, data extraction methods, and planned analyses. The completed checklist provides a robust foundation for conducting the systematic review while maintaining compliance with established reporting standards.

This protocol has been registered in PROSPERO with the registration ID CRD42025635112. The PROSPERO record can be accessed at https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42025635112.

Authors:

  • Dr. Prieyadharshini Jayaprakasam, Mid Yorkshire NHS Trust, Wakefield, United Kingdom.
  • Dr. Jeyaram Nadarajan Saraswathy, Government Vellore Medical College, Vellore, India.
  • Dr. Arbind Kumar Choudhary, Government Erode Medical College and Hospital, Tamil Nadu, India.

This checklist serves as extended data to support the manuscript and is made publicly available to promote reproducibility and enhance the credibility of the research.

Citation:
Prieyadharshini Jayaprakasam, Jeyaram Nadarajan Saraswathy. Psychological Impact of Pregnancy Loss and the Effectiveness of Interventions: A Systematic Review and Meta-Analysis. PROSPERO 2025 CRD42025635112. Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42025635112.

 

 

Abstract (English)

Optimizing Care for Women Experiencing Pregnancy Loss: Insights from a Systematic Review and Meta-Analysis

Prieyadharshini Jayaprakasam, Jeyaram Nadarajan Saraswathy, Arbind Kumar Choudhary

Affiliation:

1. Dr. Prieyadharshini Jayaprakasam

Department of Obstetrics and Gynaecology

Mid Yorkshire NHS Trust, Wakefield

Postcode: WF1 4DG, United Kingdom

Email: p.jayaprakasam@nhs.net

2. Dr. Jeyaram Nadarajan Saraswathy

Department of Obstetrics and Gynaecology

Government Vellore Medical College, Vellore

Postcode: 632011, India

Email: jairam.cr@gmail.com

3. Dr. Arbind Kumar Chaudhary, Assistant Professor of Pharmacology, Government Erode Medical College and Hospital, Tamil Nadu, India(ORCIDID: https://orcid.org/0000-0001-8910-1745; Email: arbindkch@gmail.com; Phone: +91 78717 97278).

Corresponding Author:

Dr. Arbind Kumar Chaudhary, Assistant Professor of Pharmacology, Government Erode Medical College and Hospital, Tamil Nadu, India(ORCIDID: https://orcid.org/0000-0001-8910-1745; Email: arbindkch@gmail.com; Phone: +91 78717 97278).

Abstract

Background

Pregnancy loss, including miscarriage, stillbirth, and early losses, affects millions globally. Approximately 15-20% of pregnancies end in miscarriage, with recurrent pregnancy loss (RPL) affecting 1-2% of couples. This systematic review and meta-analysis evaluated the effectiveness of pharmacological, psychological, and assisted reproductive technology (ART) interventions in improving clinical and psychological outcomes for women experiencing pregnancy loss.

Objective

To assess the impact of pharmacological, psychological, and ART interventions on clinical and psychological outcomes in women experiencing pregnancy loss and identify gaps in healthcare delivery.

Methods

Following PRISMA guidelines, 30 studies published between 2020 and 2024 were analyzed using data from PubMed, Cochrane Library, and Embase. Studies were included if they assessed interventions for pregnancy loss, focusing on pharmacological therapies, psychological approaches, and ART. Statistical heterogeneity (I² statistic) and publication bias (Egger’s regression test) were evaluated. Subgroup and sensitivity analyses explored variations across geographic, demographic, and methodological factors.

Results

Pharmacological therapies, including mifepristone and misoprostol, significantly improved tissue expulsion (OR = 3.5, 95% CI: 2.8–4.3) and patient satisfaction. Low-dose aspirin increased live birth rates by 22% (RR = 1.22, 95% CI: 1.10–1.35). Psychological interventions such as mindfulness and art therapy reduced stress (SMD = -0.48, 95% CI: -0.65 to -0.30) and enhanced quality of life. ART interventions, especially immediate frozen embryo transfer (FET), improved clinical pregnancy rates (RR = 1.15, 95% CI: 1.07–1.23). Subgroup analyses identified lower intervention efficacy in low-resource settings, while home-based misoprostol showed safety but limited efficacy in reducing postpartum hemorrhage.

Conclusion

Integrated care approaches addressing both physical and psychological needs are effective for managing pregnancy loss. Future research should focus on optimizing protocols, addressing disparities, and ensuring equitable access to care, offering a robust evidence base for improving outcomes.

Keywords: pregnancy loss; recurrent pregnancy loss; pharmacological interventions; psychological interventions; assisted reproductive technologies; frozen embryo transfer; healthcare disparities; meta-analysis.

Methods (English)

Methods

Study Design

This study employed a systematic review and meta-analysis to evaluate the impact of various interventions on psychological and clinical outcomes in women experiencing pregnancy-related challenges. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to ensure transparency and rigor in the review process. Additionally, the PICO framework (Population, Intervention, Comparator, Outcomes) was used to structure the research question and guide data synthesis.

 

PRISMA Flow Diagram

The PRISMA flowchart mapped the study selection process as follows:

• A total of 1,200 records were identified through database searches (PubMed: 600, Embase: 400, Cochrane: 200) and an additional 40 records were retrieved manually.

• After removing 190 duplicates, 1,050 records were screened based on title and abstract.

• Of these, 100 full-text articles were assessed for eligibility, and 82 were excluded for the following reasons:

o 50 articles: Irrelevant population.

o 20 articles: Unsuitable study design.

o 12 articles: Insufficient data.

• A total of 18 studies met the inclusion criteria and were included in the qualitative and quantitative synthesis.

 

PICO Framework

The PICO framework structured the study as follows:

• Population: Women experiencing early pregnancy loss, recurrent pregnancy loss, undergoing assisted reproductive technologies (ART), or receiving antenatal care.

• Intervention: Various approaches, including mifepristone + misoprostol, mindfulness therapy, art therapy, low-dose aspirin, early essential newborn care (EENC), and frozen embryo transfer (FET) strategies.

• Comparator: Placebo, misoprostol alone, routine antenatal care, delayed transfer, or no intervention.

• Outcomes:

o Primary Outcomes: Tissue expulsion success, pregnancy rates, live birth rates, and mental health improvement.

o Secondary Outcomes: Reduction in biochemical loss, maternal satisfaction, depression scores, and adverse effects.

Data Sources and Search Strategy

Comprehensive searches were conducted in PubMed, Embase, and the Cochrane Library using a combination of medical subject headings (MeSH) terms and keywords. Additional studies were identified through manual searches of references in related articles.

 

Eligibility Criteria

• Inclusion Criteria:

Studies involving relevant populations and interventions as defined in the PICO framework were included. Both randomized controlled trials (RCTs) and observational studies reporting primary and secondary outcomes were considered.

• Exclusion Criteria:

Studies with insufficient data, non-human research, or irrelevant populations were excluded. Duplicate studies and those deemed to have high risk of bias were also removed.

Data Extraction

A standardized data extraction form was used to collect study characteristics (e.g., study design, year, location, population size), intervention details (e.g., duration, mode of delivery, components), and outcomes (primary and secondary). Two reviewers independently extracted the data to ensure accuracy and consistency.

 

Quality Assessment

The quality of included studies was assessed using validated tools:

• The Cochrane Risk of Bias Tool was applied to RCTs.

• The Newcastle-Ottawa Scale (NOS) was used for cohort and observational studies.

Discrepancies between reviewers were resolved through discussion or consultation with a third reviewer.

 

Statistical Analysis

Quantitative data were synthesized using a random-effects meta-analysis to pool effect sizes. Heterogeneity was assessed using Cochran’s Q statistic and I2I^2I2 values. Publication bias was evaluated with funnel plots and Egger’s regression test for asymmetry. Meta-regression analyses examined the impact of moderator variables (e.g., intervention duration, delivery method, population characteristics) on psychological outcomes. Subgroup analyses explored variations by type of pregnancy loss, intervention type, and geographic setting (developed vs. developing countries).

 

Thematic Synthesis

Qualitative data were synthesized using thematic analysis to explore patient and provider experiences, as well as barriers and facilitators. Data were coded and categorized into key themes.

 

Software and Tools

Data analyses were performed using RevMan (Review Manager (RevMan) [Computer program]. Version 5.4, The Cochrane Collaboration, 2020. ) for meta-analysis and R software (R Core Team. (2024). R: A language and environment for statistical computing (Version 4.4.2) and Python (Python Software Foundation. (n.d.). Python Software Foundatio) for advanced statistical analyses, including meta-regression and visualization. For data extraction and management, the free and open-source software LibreOffice Calc (The Document Foundation. (n.d.). LibreOffice Calc (Version 7.5))was used as an alternative to proprietary spreadsheet tools. This methodologically robust approach, underpinned by the PRISMA guidelines and PICO framework, ensured comprehensive and transparent analysis of the included studies. A total of 18 studies were selected, providing valuable insights into the effectiveness of interventions and informing clinical practice and future research

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Additional details

Dates

Accepted
2025-01-02
Citation Prieyadharshini Jayaprakasam, Jeyaram Nadarajan Saraswathy. Psychological Impact of Pregnancy Loss and the Effectiveness of Interventions: A Systematic Review and Meta-Analysis. PROSPERO 2025 CRD42025635112 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42025635112

Software

Repository URL
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42025635112

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