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Tytuł pozycji:

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

Tytuł:
Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.
Autorzy:
Mallett G; Departments 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.
Hill K
de Voest J
Bousleiman SZ
Allard D
Harris S
Salazar A
Clark K
Ortiz F
Bartholomew A
Dalton W
Craig J
Bickus M
Corporate Authors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network
Źródło:
Obstetrics and gynecology [Obstet Gynecol] 2020 Oct; Vol. 136 (4), pp. 731-737.
Typ publikacji:
Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
Język:
English
Imprint Name(s):
Publication: 2004- : Hagerstown, MD : Lippincott Williams & Wilkins
Original Publication: New York.
MeSH Terms:
Insurance Coverage*
Labor, Induced*/methods
Labor, Induced*/psychology
Patient Preference*/economics
Patient Preference*/ethnology
Refusal to Participate*/ethnology
Refusal to Participate*/psychology
Refusal to Participate*/statistics & numerical data
Adult ; Family Characteristics/ethnology ; Female ; Gestational Age ; Humans ; Informed Consent/psychology ; Maternal Age ; Outcome Assessment, Health Care ; Parity ; Patient Selection ; Pregnancy
References:
Soc Sci Med. 2018 Mar;200:73-82. (PMID: 29421474)
N Engl J Med. 2018 Aug 09;379(6):513-523. (PMID: 30089070)
Int J Fem Approaches Bioeth. 2008 Fall;1(2):5-22. (PMID: 19774226)
Womens Health Issues. 2013 Jan;23(1):e39-45. (PMID: 23312713)
Am J Public Health. 1994 Jan;84(1):82-8. (PMID: 8279618)
Grant Information:
U10 HD040500 United States HD NICHD NIH HHS; UG1 HD027869 United States HD NICHD NIH HHS; U10 HD040544 United States HD NICHD NIH HHS; UG1 HD040560 United States HD NICHD NIH HHS; UG1 HD087230 United States HD NICHD NIH HHS; UG1 HD053097 United States HD NICHD NIH HHS; U10 HD040485 United States HD NICHD NIH HHS; U10 HD027869 United States HD NICHD NIH HHS; UG1 HD040485 United States HD NICHD NIH HHS; U10 HD040560 United States HD NICHD NIH HHS; UG1 HD040500 United States HD NICHD NIH HHS; U10 HD040545 United States HD NICHD NIH HHS; U01 HD036801 United States HD NICHD NIH HHS; UG1 HD027915 United States HD NICHD NIH HHS; UG1 HD087192 United States HD NICHD NIH HHS; UG1 HD040544 United States HD NICHD NIH HHS; UG1 HD034208 United States HD NICHD NIH HHS; UG1 HD040512 United States HD NICHD NIH HHS; U10 HD027915 United States HD NICHD NIH HHS; UG1 HD040545 United States HD NICHD NIH HHS; U10 HD034208 United States HD NICHD NIH HHS; U10 HD053097 United States HD NICHD NIH HHS; U10 HD040512 United States HD NICHD NIH HHS; UL1 TR001873 United States TR NCATS NIH HHS; U10 HD036801 United States HD NICHD NIH HHS; U24 HD036801 United States HD NICHD NIH HHS
Molecular Sequence:
ClinicalTrials.gov NCT01990612
Entry Date(s):
Date Created: 20200914 Date Completed: 20201130 Latest Revision: 20221005
Update Code:
20240105
PubMed Central ID:
PMC7971102
DOI:
10.1097/AOG.0000000000003998
PMID:
32925629
Czasopismo naukowe
Objective: To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
Methods: This 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.
Results: From 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).
Conclusion: Frequency 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 Registration: ClinialTrials.gov, NCT01990612.

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