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.
Obstet Gynecol. 2020 Oct;136(4):731-737. doi: 10.1097/AOG.0000000000003998.
To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
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.
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).
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.
ClinialTrials.gov, NCT01990612.
评估与妊娠期间同意随机分娩诱导试验相关的产妇特征。
这是一项对低危初产妇进行的随机分组研究，随机分为 39 周时行引产或期待管理。在试验过程中，数据和安全监测委员会要求在已包含种族和民族的筛选日志上添加其他字段：产妇年龄、保险类型以及拒绝同意的原因。
从 2016 年 8 月（开始收集额外数据）到 2017 年 8 月，7112 名符合条件的妇女中有 1965 名（28%）同意参加试验。与白人妇女（24%）相比，黑人妇女（41%，调整后的优势比[aOR]1.47，95%置信区间[CI]1.24-1.74）更有可能同意，而亚洲妇女（15%，aOR 0.64，95% CI 0.48-0.84）则不太可能同意。没有私人保险的妇女更有可能同意（38%，aOR 1.55，95% CI 1.34-1.79），而有私人保险的妇女则较少同意（22%）。年轻的妇女也更有可能同意。在参与度评估并提供原因的合格妇女中（68%），更倾向于期待管理（85%），这一反应在亚洲妇女中更为常见（aOR 1.75，95% CI 1.31-2.33），而在没有私人保险的妇女中则不太常见（aOR 0.60，95% CI 0.51-0.70）。不希望参与研究在亚洲妇女中更为常见（aOR 2.41，95% CI 1.44-4.03）。因为家人或朋友反对而拒绝同意的情况在亚洲妇女（aOR 2.51，95% CI 1.27-4.95）和没有私人保险的妇女（aOR 1.68，95% CI 1.10-2.59）中更为常见。
同意率和拒绝同意的原因与年龄、保险类型以及种族和民族有关。在制定促进不同参与者代表性的招募策略时，应考虑这些发现。
ClinicalTrials.gov，NCT01990612。
