Evidence map›Paper›PMID 32428965›Full record

ArticleAmerican journal of perinatology2020

Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries.

Devin D Smith, Jessica L Pippen, Adebayo A Adesomo, Kara M Rood, Mark B Landon, Maged M Costantine

Registry-linked trialAbstract read
In one paragraph

Article in American journal of perinatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05258760 (Covid Vaccine Acceptance Among Egyptian Pregnant Women), which is not on this map. Cited by 68 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05258760 unknown statusnot on this mapstarted 2022, after this paper: background citation

Covid Vaccine Acceptance Among Egyptian Pregnant Women

TypeobservationalSponsorCairo UniversityRan2022 to 2022Enrolled1,100ConditionsCOVID-19
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Social Media Misinformation about Pregnancy and COVID-19 Vaccines: A Systematic Review.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Treatment of COVID-19 in pregnant women: A systematic review and meta-analysis.European journal of obstetrics, gynecology, and reproductive biology · 2021
    Pooled it
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  7. Trial
  8. A python's embrace? Insurance and the global clinical trial.Health research policy and systems · 2026
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  19. EGFR-targeted ionizable lipid nanoparticles enhance in vivo mRNA delivery to the placenta.Journal of controlled release : official journal of the Controlled Release Society · 2024
    Article
  20. Article

8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Devin D SmithDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.ORCID 0000-0003-4185-6414
Jessica L PippenDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.
Adebayo A AdesomoDepartment of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.
Kara M RoodDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.
Mark B LandonDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.
Maged M CostantineDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.

Funding

NICHD Maternal Fetal Medicine Units NetworkUG1HD027915 · NICHD · OHIO STATE UNIVERSITY · PI Maged Costantine · 2016 to 2026
$3.3M
1/2 A randomized controlled trial of pravastatin to prevent preeclampsia in high-risk womenUG3HL140131 · NHLBI · UNIVERSITY OF TEXAS MED BR GALVESTON · PI COSTANTINE, MAGED, LAWRENCE CLEARY, KIRSTEN · 2018 to 2018
$153k
NHLBI NIH HHS UG3 HL140131NICHD NIH HHS UG1 HD027915
6 · The paper itself

Abstract

objectivePregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. STUDY

designWe conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each.

resultsAmong 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials.

conclusionApproximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While "ethical" concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. KEY POINTS: · Pregnancy was excluded from past pandemic research.. · Pregnancy is being excluded from COVID-19 research.. · Exclusion of pregnant women is potentially harmful..

Indexed as

Clinical Trials as TopicCoronavirus InfectionsPandemicsPneumonia, ViralPregnancy Complications, InfectiousBetacoronavirusCOVID-19Eligibility DeterminationFemaleGlobal HealthHumansPatient SelectionPregnancyRegistriesSARS-CoV-2

Identifiers

PMID32428965
PMCPMC7356075

What OpenQuestion holds

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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.