Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL (Dr Cozzi, Ms Jauk, and Drs Szychowski, Tita, Battarbee, and Subramaniam); Departments of Obstetrics and Gynecology (Drs Cozzi, Szychowski, Tita, Battarbee, and Subramaniam).
Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, AL (Dr Cozzi, Ms Jauk, and Drs Szychowski, Tita, Battarbee, and Subramaniam).
Am J Obstet Gynecol MFM. 2022 Nov;4(6):100729. doi: 10.1016/j.ajogmf.2022.100729. Epub 2022 Aug 19.
The association between pregnant patients participating in obstetrical studies and pregnancy outcomes is understudied.
This study aimed to evaluate the association between participation in obstetrical studies and maternal and neonatal outcomes.
This was a retrospective cohort study of all patients delivering at a single center from 2013 to 2018. Patients with pregnancy loss at <13 weeks of gestation or major fetal anomalies were excluded. Patients who enrolled in one or more obstetrical studies were categorized as "study participants" and were compared with patients who did not enroll in an obstetrical study, that is, "study nonparticipants." The primary outcome was a composite of maternal morbidity diagnosed up to 6 weeks after delivery. The secondary outcomes included composite neonatal morbidity and other perinatal outcomes. Bivariate analyses compared baseline demographics and outcomes between groups. Multivariable logistic regression was used to estimate adjusted odds ratios with 95% confidence intervals. Subgroup analyses by study design (trial or observational) were planned.
Of 19,569 patients included in this analysis, 3848 (19.7%) were study participants, and 15,721 (80.3%) were study nonparticipants. Among study participants, 3023 (78.6%) enrolled in a trial, and 825 (21.4%) enrolled in an observational study. The study participants had higher body mass index and were more likely to be younger, non-Hispanic Black, publicly insured, nulliparous, and undergo cesarean delivery than study nonparticipants. Compared with study nonparticipants, the study participants had significantly lower odds of composite maternal morbidity (9.2% vs 8.7%; adjusted odds ratio, 0.83; 95% confidence interval, 0.73-0.95) and composite neonatal morbidity (27.5% vs 18.6%; adjusted odds ratio, 0.53; 95% confidence interval, 0.48-0.58). In addition, the odds of fetal death, 5-minute Apgar score of <5, neonatal death, maternal and neonatal intensive care unit admissions, and lengths of stay were lower for study participants than for study nonparticipants. In stratified analyses, maternal morbidity was only significantly decreased among trial participants; however, there was a significantly reduced odds of neonatal morbidity, regardless of study design (trial or observational vs no study).
Participation in obstetrical studies was associated with decreased maternal and neonatal morbidities after adjusting for potential confounders. This underscored the importance of pregnant patients enrolling in obstetrical clinical studies and potentially benefiting from the additional surveillance. Further study of how study participation exerts this effect on pregnancy outcomes is warranted.
参与产科研究的孕妇与妊娠结局之间的关联尚未得到充分研究。
本研究旨在评估参与产科研究与母婴结局之间的关系。
这是一项对 2013 年至 2018 年在单一中心分娩的所有患者进行的回顾性队列研究。排除妊娠 13 周前流产或胎儿主要畸形的患者。登记一项或多项产科研究的患者被归类为“研究参与者”，并与未登记产科研究的患者（即“研究非参与者”）进行比较。主要结局是产后 6 周内诊断出的母体发病率的复合指标。次要结局包括复合新生儿发病率和其他围产期结局。采用双变量分析比较组间的基线人口统计学和结局。采用多变量逻辑回归估计 95%置信区间的调整优势比。计划进行按研究设计（试验或观察性）进行的亚组分析。
在这项分析中，纳入了 19569 名患者，其中 3848 名（19.7%）为研究参与者，15721 名（80.3%）为研究非参与者。在研究参与者中，3023 名（78.6%）参加了试验，825 名（21.4%）参加了观察性研究。与研究非参与者相比，研究参与者的身体质量指数更高，且更年轻、非西班牙裔黑人、公共保险、初产妇和剖宫产的可能性更大。与研究非参与者相比，研究参与者的复合母体发病率显著降低（9.2% vs. 8.7%；调整后的优势比，0.83；95%置信区间，0.73-0.95），复合新生儿发病率也显著降低（27.5% vs. 18.6%；调整后的优势比，0.53；95%置信区间，0.48-0.58）。此外，研究参与者的胎儿死亡、5 分钟 Apgar 评分<5、新生儿死亡、产妇和新生儿重症监护病房入院和住院时间的几率均低于研究非参与者。分层分析表明，仅在试验参与者中，母体发病率显著降低；然而，无论研究设计（试验或观察性研究与无研究）如何，新生儿发病率的几率均显著降低。
在调整了潜在混杂因素后，参与产科研究与母婴发病率降低相关。这强调了孕妇参与产科临床研究并可能从额外监测中受益的重要性。进一步研究研究参与如何对妊娠结局产生这种影响是有必要的。
