ReviewThe Lancet. Global health2021
Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.
Review in The Lancet. Global health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 80 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
80 citing papers in PubMed, 3 syntheses or guidelines pooled it, 166 citations in OpenAlex.
- Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.PLoS medicine · 2024Pooled it
- Recruitment of pregnant women to randomised trials of COVID 19 treatments, and pharmaceutical treatments received outside such trials: A research article.European journal of obstetrics, gynecology, and reproductive biology · 2022Pooled it
- Treatment of COVID-19 in pregnant women: A systematic review and meta-analysis.European journal of obstetrics, gynecology, and reproductive biology · 2021Pooled it
- Efficacy and safety of hydroxychloroquine for treatment of mild SARS-CoV-2 infection and prevention of COVID-19 severity in pregnant and postpartum women: A randomized, double-blind, placebo-controlled trial.Acta obstetricia et gynecologica Scandinavica · 2024Trial
- Single-cell mapping of peripheral immune dynamics in pregnant women after Moderna mRNA COVID-19 vaccination.Genes and immunity · 2026Article
- Assessing the Use of Medical Insurance Claims and Electronic Health Records to Measure COVID-19 Vaccination During Pregnancy.Drug safety · 2026Article
- Redesigning medicine: integrating sex and gender for better health outcomes.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- Pregnant women's attitudes and intentions toward tuberculosis, malaria, group B streptococcus, and respiratory syncytial virus vaccines in pregnant: Findings from a cross-sectional study of pregnant women living in Brazil, Ghana, Kenya, and Pakistan.PLOS global public health · 2026Article
- Innovative design and modelling to improve sex and gender analysis in clinical trials.BMJ (Clinical research ed.) · 2025Article
- Article
- Inclusion of under-served groups in trials: an audit at a UK primary care clinical trials unit.Trials · 2025Article
- SARS-CoV-2 infection in pregnant women and incidence of thromboembolic disease: an analysis of the Covid-19-Related Obstetric and Neonatal Outcome Study (CRONOS) in Germany.Archives of gynecology and obstetrics · 2025Observational
- COVID-19 Antiviral Medication Use Among Pregnant and Recently Pregnant US Outpatients.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people.Communications medicine · 2024Review
- SARS-CoV-2, Tdap, and influenza vaccination during pregnancy from 2019 to 2022 in Ontario, Canada: a population-based retrospective cohort study.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024Article
- Article
- Differential impacts of health systems and sociocultural environment on vulnerable populations during the COVID-19 pandemic: lessons from four Asia-Pacific countries.BMC public health · 2024Article
- Safety of Monoclonal Antibodies as Treatment for Coronavirus Disease 2019 (COVID-19) During Pregnancy: A Systematic Review.O&G open · 2024Review
- Maternal and perinatal health research during emerging and ongoing epidemic threats: a landscape analysis and expert consultation.BMJ global health · 2024Article
20 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
14 authors at 1 institution in 2 countries.
Funding
Abstract
Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.