Department of Obstetrics and Gynecology, Christiana Care, Newark, DE.
Department of Obstetrics and Gynecology, Christiana Care, Newark, DE.
Am J Obstet Gynecol. 2021 May;224(5):524.e1-524.e8. doi: 10.1016/j.ajog.2021.02.016. Epub 2021 Feb 19.
Combining pharmacologic agents with mechanical ripening achieves the shortest time to labor; however, there is no clear evidence on route of drug administration. Buccal administration of misoprostol has shown greater patient acceptance but remains understudied.
This study aimed to evaluate the difference in time to delivery between buccal and vaginal administration of misoprostol along with a Foley catheter for induction of labor.
The BEGIN trial (buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term) was an institutional review board-approved, randomized clinical trial conducted from June 2019 to January 2020 comparing identical doses (25 μg) of buccal misoprostol and vaginal misoprostol along with a Foley catheter for induction of labor. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction of labor at ≥37 weeks with a singleton gestation and needing cervical ripening were included. Our primary outcome was time to delivery. Kruskal-Wallis, Pearson chi-squared, and Cox survival analyses with intent-to-treat principles were performed. A sample size of 216 was planned to detect a 4-hour reduction in delivery time.
A total of 215 women (108 in the buccal drug administration group and 107 in the vaginal drug administration group) were randomized. The vaginal route of drug administration achieved a faster median time to delivery than the buccal route of drug administration (19.7 hours in the vaginal route vs 24.1 hours in the buccal route; P<.001). A greater percentage of women in the vaginal drug administration group delivered within 24 hours compared with the buccal drug administration group (65% vs 49%; P=.02). There was no difference in the cesarean delivery rate between the 2 groups (17% in the vaginal drug administration group vs 21% in the buccal drug administration group; P=.6). Individuals who received vaginal misoprostol with Foley catheter delivered 2 times faster than women who received buccal misoprostol with Foley catheter after censoring for cesarean delivery and adjusting for parity (hazard ratio, 2.13; 95% confidence interval, 1.44-3.17). There was no significant difference in maternal and neonatal outcomes.
We found that vaginal administration of misoprostol was superior to buccal administration of misoprostol along with a Foley catheter for induction of labor. Furthermore, vaginal administration of misoprostol resulted in twice the chance of delivering earlier compared with buccal administration of misoprostol with no difference in cesarean delivery rates. Therefore, the vaginal route of administration of misoprostol should be preferred among individuals undergoing a combined pharmacologic and mechanical induction.
联合使用药物和机械方法来促进宫颈成熟可以达到最短的分娩时间；然而，药物给药途径方面尚无明确证据。口腔给药米索前列醇具有更好的患者接受度，但研究仍不足。
本研究旨在评估口腔与阴道给药米索前列醇联合 Foley 导管在促进分娩方面的分娩时间差异。
BEGIN 试验（口腔 vs 阴道米索前列醇联合 Foley 导管在足月时促进宫颈成熟）是一项机构审查委员会批准的、于 2019 年 6 月至 2020 年 1 月进行的随机临床试验，比较了口腔和阴道给予相同剂量（25μg）米索前列醇联合 Foley 导管用于引产。随机分组按产次分层。参与者的分娩管理是标准化的。纳入在 37 周及以上、单胎妊娠且需要宫颈成熟的个体。我们的主要结局是分娩时间。采用 Kruskal-Wallis、Pearson 卡方检验和 Cox 生存分析，采用意向治疗原则。计划纳入 216 例患者，以检测分娩时间缩短 4 小时。
共纳入 215 例女性（口腔药物组 108 例，阴道药物组 107 例）。阴道给药途径的中位分娩时间快于口腔给药途径（阴道途径 19.7 小时 vs 口腔途径 24.1 小时；P<.001）。与口腔药物组相比，阴道药物组有更多的女性在 24 小时内分娩（65% vs 49%；P=.02）。两组剖宫产率无差异（阴道药物组 17% vs 口腔药物组 21%；P=.6）。在排除剖宫产并调整产次后，阴道给予 Foley 导管的米索前列醇组比口腔给予 Foley 导管的米索前列醇组分娩时间快 2 倍（风险比，2.13；95%置信区间，1.44-3.17）。母婴结局无显著差异。
我们发现，与 Foley 导管联合口腔给予米索前列醇相比，阴道给予米索前列醇在促进分娩方面更优。此外，与口腔给予米索前列醇相比，阴道给予米索前列醇可使分娩提前的可能性增加一倍，而剖宫产率无差异。因此，在联合使用药物和机械方法引产时，应优先选择阴道给予米索前列醇。
