Evidence map›Paper›PMID 25425722›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2014

Designing drug trials: considerations for pregnant women.

Jeanne S Sheffield, David Siegel, Mark Mirochnick, R Phillips Heine, Christine Nguyen, Kimberly L Bergman, Rada M Savic, Jill Long, Kelly E Dooley, Mirjana Nesin

Open access · greenAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 5% 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

64 citing papers in PubMed, 1 synthesis or guideline pooled it, 125 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Trial
  4. Article
  5. Article
  6. Article
  7. Plants (Basel, Switzerland) · 2025
    Review
  8. Article
  9. Article
  10. Mechanisms of altered hepatic drug disposition during pregnancy: small molecules.Expert opinion on drug metabolism & toxicology · 2025
    Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review

4 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

10 authors at 7 institutions in 1 country.

Jeanne S SheffieldDivision of Maternal-Fetal Medicine, University of Texas Southwestern Medical Center, Dallas.
David SiegelNational Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Mark MirochnickDivision of Neonatology, Boston University, Massachusetts.
R Phillips HeineDivision of Maternal-Fetal Medicine, Duke University, Durham, North Carolina.
Christine NguyenDivision of Bone, Reproductive, and Urologic Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research.
Kimberly L BergmanOffice of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland.
Rada M SavicDepartment of Bioengineering, School of Pharmacy, University of California, San Francisco.
Jill LongDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Kelly E DooleyDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Mirjana NesinDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
National Institutes of Health · USCenter for Drug Evaluation and Research · USDuke University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USJohns Hopkins Medicine · USUnited States Food and Drug Administration · USUniversity of California, San Francisco · US

Funding

Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIGMS NIH HHS T32 GM066691
6 · The paper itself

Abstract

Clinical pharmacology studies that describe the pharmacokinetics and pharmacodynamics of drugs in pregnant women are critical for informing on the safe and effective use of drugs during pregnancy. That being said, multiple factors have hindered the ability to study drugs in pregnant patients. These include concerns for maternal and fetal safety, ethical considerations, the difficulty in designing appropriate trials to assess the study objectives, and funding limitations. This document summarizes the recommendations of a panel of experts convened by the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. These experts were charged with reviewing the issues related to the development of preclinical and clinical drug studies in pregnant women and to develop strategies for addressing these issues. These findings may also be utilized in the development of future drug studies involving pregnant women and their fetus/neonate.

Indexed as

Clinical ProtocolsClinical Trials as TopicPregnant PeopleAdultFemaleHumansInfantMaternal-Fetal ExchangePharmacokineticsPlacentaPregnancyPregnancy OutcomeResearch DesignUnited StatesUnited States Food and Drug Administrationdrug trialspharmacokineticspregnancy

Identifiers

PMID25425722
PMCPMC4303056
OpenAlexW2011023293

What OpenQuestion holds

Textmetadata
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.