宫颈内 Foley 导管联合与不联合缩宫素用于引产：一项随机对照试验。
Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial.
机构信息
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania; and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, Delaware.
出版信息
Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.
OBJECTIVE
To evaluate whether adding oxytocin to preinduction cervical ripening with a Foley catheter increases the rate of delivery within 24 hours.
METHODS
This was a randomized, multicenter, parallel trial of women with a singleton pregnancy at 24 weeks of gestation or greater undergoing labor induction. Women were randomly allocated to an intracervical Foley catheter followed by oxytocin or Foley with concurrent oxytocin infusion. Nulliparous and multiparous women were randomized and analyzed separately based on parallel design. The primary outcome was Foley placement to delivery at 24 hours or less. A sample size of 100 nulliparous women and 75 multiparous women per group would be required to detect a 20% increase in baseline 24-hour delivery rate with 80% power for each parity group.
RESULTS
From January 2015 through July 2016, 323 patients were enrolled: 184 nulliparous women and 139 multiparous women. Nulliparous women who received concurrent Foley and oxytocin delivered more frequently within 24 hours of Foley placement than did the Foley followed by oxytocin group (64% compared with 43%, P=.003, relative risk 1.51, 95% confidence interval [CI] 1.14-2.00). Multiparous women who received concurrent Foley and oxytocin delivered more frequently within 24 hours than the Foley followed by oxytocin group (87% compared with 72%, relative risk 1.22, 95% CI 1.02-1.45). Median time to delivery was shorter in both nulliparous women (20.9 compared with 26.1 hours, P<.001) and in multiparous women, (14.9 compared with 18.6 hours, P=.01) who received concurrent Foley and oxytocin compared with Foley followed by oxytocin. There were no significant differences in the rates of cesarean delivery, postpartum hemorrhage, chorioamnionitis, or neonatal intensive care unit admission between the randomization groups.
CONCLUSION
Induction with concurrent oxytocin infusion added to Foley significantly increases the rate of delivery within 24 hours in both nulliparous and multiparous compared with Foley followed by oxytocin.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02273115.
目的
评估在 Foley 导管行宫颈成熟术前加入催产素是否能提高 24 小时内分娩的比例。
方法
这是一项在 24 孕周或以上、行引产的单胎妊娠孕妇中进行的随机、多中心、平行试验。将孕妇随机分为行 Foley 导管术并随后给予催产素或 Foley 导管术同时给予催产素输注。根据平行设计，将初产妇和经产妇分别随机分组并进行分析。主要结局是 24 小时内 Foley 放置至分娩。每个产次组需要 100 名初产妇和 75 名经产妇，才能检测到基线 24 小时分娩率提高 20%，每个产次组的效能为 80%。
结果
2015 年 1 月至 2016 年 7 月，共纳入 323 名患者：184 名初产妇和 139 名经产妇。初产妇中，同时给予 Foley 和催产素的患者在 Foley 放置后 24 小时内分娩的比例高于仅给予 Foley 导管术随后给予催产素的患者（64%比 43%，P=0.003，相对风险 1.51，95%置信区间 [CI] 1.14-2.00）。同时给予 Foley 和催产素的经产妇在 24 小时内分娩的比例也高于仅给予 Foley 导管术随后给予催产素的患者（87%比 72%，相对风险 1.22，95%CI 1.02-1.45）。初产妇（20.9 比 26.1 小时，P<0.001）和经产妇（14.9 比 18.6 小时，P=0.01）中，同时给予 Foley 和催产素的患者中位分娩时间均短于仅给予 Foley 导管术随后给予催产素的患者。两组随机分组的剖宫产率、产后出血、绒毛膜羊膜炎或新生儿重症监护病房入院率无显著差异。
结论
与 Foley 导管术随后给予催产素相比，Foley 导管术同时给予催产素输注显著提高了初产妇和经产妇 24 小时内的分娩率。
临床试验注册
ClinicalTrials.gov，https://clinicaltrials.gov/，NCT02273115。
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