Evidence map›Paper›PMID 32925629›Full record

Trial reportObstetrics and gynecology2020

Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.

Gail Mallett, Kim Hill, Jessica de Voest, Sabine Z Bousleiman, Donna Allard, Stacy Harris, Ashley Salazar, Kelly Clark, Felecia Ortiz, Anna Bartholomew and 4 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01990612 (Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

NCT01990612 nacompletednot on this map

Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

TypeinterventionalSponsorThe George Washington University Biostatistics CenterRan2014 to 2018Enrolled6,106ConditionsLabor and DeliveryArmsElective Induction of Labor
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
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

14 authors.

Gail MallettDepartments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.
Kim Hill
Jessica de Voest
Sabine Z Bousleiman
Donna Allard
Stacy Harris
Ashley Salazar
Kelly Clark
Felecia Ortiz
Anna Bartholomew
Wendy Dalton
Jennifer Craig
Melissa Bickus
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network

Funding

Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research NetU10HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI CLIFTON, REBECCA GERSNOVIEZ · 2009 to 2021
$174.2M
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
SARS-CoV-2 Vaccine Pregnancy RegistryU24HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI Rebecca Gersnoviez Clifton · 2021 to 2026
$39.2M
MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTRU01HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI THOM, ELIZABETH ANN · 1998 to 2008
$27.0M
NICHD Maternal Fetal Medicine Units NetworkU10HD034208 · NICHD · UNIVERSITY OF UTAH · PI VARNER, MICHAEL W. · 1996 to 2015
$16.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD027869 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 1991 to 2015
$12.8M
NICHD Maternal Fetal Medicine Units NetworkU10HD040485 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAPNER, RONALD · 2001 to 2015
$12.5M
NICHD Maternal Fetal Medicine Units NetworkU10HD040560 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI THORP, JOHN M · 2001 to 2015
$10.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040545 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CHAUHAN, SUNEET P · 2001 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040500 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI ROUSE, DWIGHT J · 2001 to 2015
$7.5M
NCATS NIH HHS UL1 TR001873NICHD NIH HHS U01 HD036801NICHD NIH HHS U10 HD027869NICHD NIH HHS U10 HD027915NICHD NIH HHS U10 HD034208NICHD NIH HHS U10 HD036801NICHD NIH HHS U10 HD040485NICHD NIH HHS U10 HD040500NICHD NIH HHS U10 HD040512NICHD NIH HHS U10 HD040544NICHD NIH HHS U10 HD040545NICHD NIH HHS U10 HD040560NICHD NIH HHS U10 HD053097NICHD NIH HHS U24 HD036801NICHD NIH HHS UG1 HD027869NICHD NIH HHS UG1 HD027915NICHD NIH HHS UG1 HD034208NICHD NIH HHS UG1 HD040485NICHD NIH HHS UG1 HD040500NICHD NIH HHS UG1 HD040512NICHD NIH HHS UG1 HD040544NICHD NIH HHS UG1 HD040545NICHD NIH HHS UG1 HD040560NICHD NIH HHS UG1 HD053097NICHD NIH HHS UG1 HD087192NICHD NIH HHS UG1 HD087230
6 · The paper itself

Abstract

objectiveTo evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.

methodsThis is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.

resultsFrom August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59).

conclusionFrequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation. CLINICAL

trial registrationClinialTrials.gov, NCT01990612.

Indexed as

Insurance CoverageLabor, InducedPatient PreferenceRefusal to ParticipateAdultFamily CharacteristicsFemaleGestational AgeHumansInformed ConsentMaternal AgeOutcome Assessment, Health CareParityPatient SelectionPregnancy

Identifiers

PMID32925629
PMCPMC7971102

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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.