Effect of extra-amniotic Foley's catheter and vaginal misoprostol versus vaginal misoprostol alone on cervical ripening and induction of labor in Kenya, a randomized controlled trial.
Effect of extra-amniotic Foley's catheter and vaginal misoprostol versus vaginal misoprostol alone on cervical ripening and induction of labor in Kenya, a randomized controlled trial.
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DOI：
10.1186/s12884-018-1793-2
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发表时间：
2018-07-12
影响因子：
3.1
通讯作者：
Maranga I
中科院分区：
文献类型：
--
作者：
Osoti A;Kibii DK;Tong TMK;Maranga I
最安全、最有效和最快的联合引产方法尚不清楚。在一项开放的随机临床试验中，我们评估了羊膜外Foley‘s导管和阴道米索前列醇联合用于宫颈成熟和引产的效果，并比较了引产失败、引产间隔和不良母婴结局的发生率。在肯尼亚肯雅塔国家医院入院引产的胎龄在28周或以上的孕妇被随机分为两组，一组是羊膜外Foley导管充气30cm3生理盐水和25微克阴道米索前列醇，另一组是单独使用25微克米索前列醇。妇女每小时接受6次审查，并在需要时额外插入米索前列醇。主要结果是诱导失败的发生率。次要结果是从引产到分娩的间隔时间以及不良的母婴结局。我们进行了意向处理分析，并使用t检验或Wilcoxon等级比较平均数或中位数，适当使用卡方或Fishers检验比较比例。采用对数等级检验比较引产至分娩间隔时间。排除零值的<； 0.05和95%可信区间的P值被认为具有统计学意义。在2016年2月至5月期间，我们招募了237名入院引产的孕妇中的180人，并将她们随机分为羊膜外Foley导管和阴道米索前列醇组合(n= 90)或单独阴道米索前列醇(n= 90)。两组的社会人口学和产科特征相似。联合应用羊膜外Foley导尿管和阴道米索前列醇的引产失败率(8.9%)低于单纯阴道米索前列醇(11.1%)，但差异无统计学意义。羊膜外Foley‘s导管加阴道米索前列醇组平均引产至分娩时间(平均18.9，标准差(SD)7.2h)较单用米索前列醇组(平均14.1SD，6.9h)缩短4.8h(对数检验，p<； 0.001)。两组母体和围产期并发症相似。羊膜外Foley‘s导管和阴道米索前列醇用于宫颈成熟和引产，与单纯阴道米索前列醇相比，引产失败的发生率没有显着降低，但安全地缩短了引产至分娩时间。试验追溯登记于2016年3月14日PACTR201604001535825。本文的在线版本(10.1186/s12884-0181793-2)包含向授权用户提供的补充材料。
The safest, most effective and fastest combined approaches to induction of labor is unknown. In an open-label randomized clinical trial we evaluated the efficacy of combination of extra-amniotic Foley’s catheter and vaginal misoprostol compared to vaginal misoprostol alone for cervical ripening and induction of labor on the incidence of failed induction, induction-to-delivery interval and adverse maternal and perinatal outcomes. Pregnant women at gestational age of 28 weeks or greater admitted at Kenyatta National Hospital, Kenya for induction of labor were enrolled then randomized to either a combination of extra-amniotic Foley’s catheter inflated by 30 cm3 of normal saline and 25 micrograms of vaginal misoprostol or 25 micrograms of vaginal misoprostol alone. Women underwent 6 hourly reviews and additional misoprostol inserted if required. The primary outcome was incidence of failed induction. Secondary outcomes were induction-to-delivery interval and adverse maternal and perinatal outcomes. We conducted an intent-to-treat analysis and compared means or medians using t-test or Wilcoxon rank, proportions using Chi-square or Fishers test as appropriate. Induction-to-delivery interval were compared using the log-rank test. P-values of < 0.05 and 95% confidence intervals that excluded the null were considered statistically significant. Between February and May 2016, we enrolled 180 of 237 pregnant women admitted for induction of labor and randomized them to either a combination of extra-amniotic Foley’s catheter and vaginal misoprostol (n = 90) or vaginal misoprostol alone (n = 90). The socio-demographic and obstetric characteristics were similar between the two groups. Failed induction rates were lower but not statistically significant following combined extra-amniotic Foley’s catheter and vaginal misoprostol (8.9%) versus vaginal misoprostol alone (11.1%). The mean induction-to-delivery time was 4.8 h shorter in the combined extra-amniotic Foley’s catheter and vaginal misoprostol (mean 18.9, standard deviation (SD) 7.2 h) compared to misoprostol only group (mean 14.1, SD 6.9 h) (log-rank test, p < 0.001). Maternal and perinatal complications were similar between the two groups. Extra-amniotic Foley’s catheter and vaginal misoprostol for cervical ripening and induction of labor did not significantly lower the incidence of failed induction but safely shortened induction-to-delivery time compared to vaginal misoprostol only. Trial was retrospectively registered on 14–03-2016 PACTR201604001535825. The online version of this article (10.1186/s12884-018-1793-2) contains supplementary material, which is available to authorized users.
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影响因子：
1.5
作者：
Lin, Monique G.;Rouse, Dwight J.
通讯作者：
Rouse, Dwight J.
DOI：
10.1067/s0002-9378(03)00842-1
发表时间：
2003-10-01
影响因子：
9.8
作者：
Chung, JH;Huang, WH;Nageotte, MP
通讯作者：
Nageotte, MP
影响因子：
2
作者：
Hill, James B.;Thigpen, Brad D.;Martin, James N., Jr.
通讯作者：
Martin, James N., Jr.
影响因子：
7.2
作者：
通讯作者：
--
影响因子：
7.2
作者：
Carbone, Jeanine F.;Tuuli, Methodius G.;Macones, George A.
通讯作者：
Macones, George A.