Evidence map›Paper›PMID 32306165›Full record

ReviewJournal of pharmacokinetics and pharmacodynamics2020

Challenges in conducting clinical research studies in pregnant women.

Monique McKiever, Heather Frey, Maged M Costantine

Open access · greenAbstract readReview
In one paragraph

Review in Journal of pharmacokinetics and pharmacodynamics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Obstetric Pharmacoethics: An ethical framework for obstetric pharmacology.European journal of obstetrics, gynecology, and reproductive biology · 2026
    Article
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  11. PregMedNet: Multifaceted Maternal Medication Impacts on Neonatal Complications.medRxiv : the preprint server for health sciences · 2025
    Article
  12. Article
  13. Review
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  15. Article
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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

3 authors at 1 institution in 1 country.

Monique McKieverDivision of Maternal Fetal Medicine, Department Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, 395 W12th Avenue, Columbus, OH, 43210, USA.
Heather FreyDivision of Maternal Fetal Medicine, Department Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, 395 W12th Avenue, Columbus, OH, 43210, USA.
Maged M CostantineDivision of Maternal Fetal Medicine, Department Obstetrics & Gynecology, The Ohio State University Wexner Medical Center, 395 W12th Avenue, Columbus, OH, 43210, USA. Maged.Costantine@osumc.edu.ORCID 0000-0003-4076-469X
The Ohio State University Wexner Medical Center · US

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 womenUH3HL140131 · NHLBI · UNIVERSITY OF TEXAS MED BR GALVESTON · PI COSTANTINE, MAGED · 2019 to 2023
$366k
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development 5 UG1 HD027915-29NHLBI NIH HHS 1UG3HL140131-01NHLBI NIH HHS UG3 HL140131NHLBI NIH HHS UH3 HL140131NICHD NIH HHS UG1 HD027915
6 · The paper itself

Abstract

Maternal mortality and morbidity continue to rise in the United States. Despite these trends there are limited novel interventions to investigate and improve these metrics, partly due to research protocol limitations which restrict participation of pregnant women. Inclusion of pregnant women in research studies is integral to the process of obtaining important information regarding the safety and efficacy of therapeutics or interventions to improve maternal health and pregnancy outcomes. While significant changes in research practices have resulted in an increase of female participants, there remains a paucity of research trials directly targeting pregnant and lactating women. This article provides an overview of issues surrounding inclusion of pregnant or breastfeeding women in research studies, and includes historical perspectives, navigating concerns over safety profile, considerations for appropriate development, and future perspectives.

Indexed as

Patient SelectionBreast FeedingClinical Trials as TopicFemaleHealthy VolunteersHumansMaternal MortalityPregnancyPregnancy ComplicationsUnited StatesBreastfeedingClinical researchDrug developmentObstetricsPharmacologyPregnancy

Identifiers

PMID32306165
PMCPMC8237366
OpenAlexW3017270207

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.