门诊 Foley 导尿管用于初产妇引产：一项随机对照试验。
Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial.
机构信息
Center for Women's Reproductive Health, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; and Tri-State Perinatology, Deaconess-The Women's Hospital, Newburgh, Indiana.
出版信息
Obstet Gynecol. 2020 Sep;136(3):597-606. doi: 10.1097/AOG.0000000000004041.
OBJECTIVE
To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery.
METHODS
We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours.
RESULTS
From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3-7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4-15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4-1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8-3.9, P=.16) were not significantly different between groups.
CONCLUSION
In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery.
CLINCAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03472937.
目的
评估初产妇经阴道放置 Foley 导管行门诊宫颈成熟术是否能缩短从入院到分娩的时间。
方法
我们对孕 39 周或以上、改良 Bishop 评分<5 分且行择期引产的单胎妊娠患者进行了一项随机对照试验。患者被 1:1 随机分配至门诊或住院经阴道 Foley 导管组。在门诊组，Foley 导管在入院前一天插入，以便安排引产；在住院组，Foley 导管在计划入院时插入。主要结局是从入院到分娩单元到分娩的时间。根据 80%的效能和双侧 0.05 的 α 值，估计需要 126 例样本量，以检测从入院到分娩的平均时间在两组之间至少有 5 小时的差异，该差异基于 19±10 小时的基线时间。
结果
2018 年 5 月至 2019 年 10 月，共有 126 名女性被随机分配至两组，每组 63 名。两组之间的基线特征平衡，除门诊组的体重指数（31±5.4 比 34±7.5，P=.01）和 B 组链球菌定植（31%比 54%，P=.01）较低外。门诊组从入院到分娩的时间更短（17.4±7.4 比 21.7±9.1 小时，P<.01，平均差异 4.3 小时，95%CI 1.3-7.2）。门诊组的计划引产前入院率更高（22%比 5%，相对风险[RR] 4.7，95%CI 1.4-15.4，P<.01），入院时改良 Bishop 评分中位数也更高（3 分比 1 分，P<.01）。两组之间剖宫产率（24%比 32%，RR 0.8，95%CI 0.4-1.3，P=.32）和绒毛膜羊膜炎（22%比 13%，RR 1.8，95%CI 0.8-3.9，P=.16）差异无统计学意义。
结论
在择期行足月引产的初产妇中，经阴道放置 Foley 导管行门诊宫颈成熟术可缩短从入院到分娩的时间。
临床试验注册
ClinicalTrials.gov，NCT03472937。
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