Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.
Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.
Am J Perinatol. 2023 Nov;40(15):1695-1703. doi: 10.1055/s-0041-1740010. Epub 2021 Dec 14.
This study aimed to examine whether vaginal progesterone is noninferior to 17-α hydroxyprogesterone caproate (17OHP-C) in the prevention of recurrent preterm birth (PTB).
This retrospective cohort study included singleton pregnancies among women with a history of spontaneous PTB who received prenatal care at a single tertiary center from 2011 to 2016. Pregnancies were excluded if progesterone was not initiated prior to 24 weeks or the fetus had a major congenital anomaly. The primary outcome was PTB <37 weeks. A priori, noninferiority was to be established if the upper bound of the adjusted two-sided 90% confidence interval (CI) for the difference in PTB fell below 9%. Inverse probability of treatment weighting (IPTW) was used to carefully control for confounding associated with choice of treatment and PTB. Adjusted differences in PTB proportions were estimated via IPTW regression, with standard errors adjustment for multiple pregnancies per woman. Secondary outcomes included PTB <34 and <28 weeks, spontaneous PTB, neonatal intensive care unit admission, and gestational age at delivery.
Among 858 pregnancies, 41% ( = 353) received vaginal progesterone and 59% ( = 505) were given 17OHP-C. Vaginal progesterone use was more common later in the study period, and among women who established prenatal care later, had prior PTBs at later gestational ages, and whose race/ethnicity was neither non-Hispanic white nor non-Hispanic Black. Vaginal progesterone did not meet noninferiority criteria compared with 17-OHPC in examining PTB <37 weeks, with an IPTW adjusted difference of 3.4% (90% CI: -3.5, 10.3). For secondary outcomes, IPTW adjusted differences between treatment groups were generally small and CIs were wide.
We could not conclude noninferiority of vaginal progesterone to 17OHP-C; however, women and providers may be willing to accept a larger difference (>9%) when considering the cost and availability of vaginal progesterone versus 17OHP-C. A well-designed randomized trial is needed.
· Vaginal progesterone is not noninferior to 17OHP-C.. · PTB risk may be 10% higher with vaginal progesterone.. · Associations did not differ based on obesity status..
本研究旨在探讨阴道用黄体酮是否不比 17-α 羟孕酮己酸酯（17OHP-C）更能预防复发性早产（PTB）。
本回顾性队列研究纳入了 2011 年至 2016 年在一家三级中心接受产前护理的有自发性 PTB 史的单胎妊娠女性。如果黄体酮在 24 周前未开始使用或胎儿有重大先天异常，则排除妊娠。主要结局为<37 周的 PTB。如果调整后的双侧 90%置信区间（CI）上限低于 9%，则可确定非劣效性。采用逆概率治疗加权（IPTW）仔细控制与治疗选择和 PTB 相关的混杂因素。通过 IPTW 回归估计调整后的 PTB 比例差异，并对每位女性的多胎妊娠进行标准误差调整。次要结局包括<34 周和<28 周的 PTB、自发性 PTB、新生儿重症监护病房入院和分娩时的胎龄。
在 858 例妊娠中，41%（n=353）接受了阴道用黄体酮，59%（n=505）接受了 17OHP-C。阴道用黄体酮的使用在研究后期更为常见，在那些较晚建立产前护理、较晚的妊娠周数发生过 PTB、种族/民族既不是非西班牙裔白人也不是非西班牙裔黑人的女性中更为常见。与 17-OHPC 相比，阴道用黄体酮在检查<37 周的 PTB 时不符合非劣效性标准，IPTW 调整后的差异为 3.4%（90%CI：-3.5，10.3）。对于次要结局，治疗组之间的 IPTW 调整差异通常较小，CI 较宽。
我们不能得出阴道用黄体酮与 17OHP-C 相比非劣效的结论；然而，当考虑阴道用黄体酮与 17OHP-C 的成本和可用性时，女性和提供者可能愿意接受更大的差异（>9%）。需要一项精心设计的随机试验。
·阴道用黄体酮不比 17OHP-C 更能预防复发性早产。·使用阴道用黄体酮，PTB 风险可能增加 10%。·关联结果不因肥胖状况而异。
