Landscape Analysis of Pregnancy Exposure Registries in Low- and Middle-Income Countries: a Scoping Review

Introduction

Drug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.

Objectives

To identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programs can better support maternal populations in these countries.

Design

Scoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.

Data sources

Electronic search of Medline/PubMed, Embase, CINAHL, and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.

Eligibility criteria

Eligible resources included registries, surveillance systems, and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal, and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.

Data extraction and synthesis

Search results were screened and data extracted using a standardized form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorized by resource type.

Results

A total of 7,515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in Africa, Asia, and Latin America LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarized according to key features, strengths and weaknesses.

Conclusions

This scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step toward improving safe, world-wide access to life-saving interventions for pregnant populations.

Study registration

The protocol for this review has been registered with Open Science Framework (DOI: https://doi.org/10.17605/OSF.IO/FU5AT ).

Article Summary: Strengths and limitations of this study

• This analysis documents pregnancy registries and similar systems in low- and middle-income countries for monitoring the safety of drugs and vaccines.

• This scoping review employed a structured search of the published scientific literature, augmented by a grey literature search, online survey and expert consultations.

• Some registries, particularly those without publications or accessible websites, may nevertheless have been missed in this review.

• Registries were not always thorough in reporting the details of their methods, strengths, and limitations in their publications.