Sharma Chanderdeep, Soni Anjali, Gupta Amit, Verma Ashok, Verma Suresh
Dr Rajendra Prasad Government Medical College, Kangra at Tanda, HP, 176001, India.
Arch Gynecol Obstet. 2017 Aug;296(2):241-248. doi: 10.1007/s00404-017-4431-8. Epub 2017 Jun 17.
To compare oral mifepristone (400 mg) with trans-cervical balloon catheter for induction of labor (IOL) in post date women with previous one cesarean section (CS).
In this randomized trial, post date pregnant women (gestation 40 weeks 5 days), with previous one low segment CS (no previous vaginal delivery) were induced either with oral mifepristone (400 mg) or balloon catheter [Foley's catheter (16 Fr); bulb filled with 30 ml normal saline]. They were re-assessed 24 and 48 h later. If at any time Bishop Score was >6; amniotomy was done, followed by oxytocin infusion. Primary outcome of the study was labor onset after first manoeuvre. Secondary outcomes were cervical ripening, need of oxytocin, vaginal delivery and CS, in two groups.
From June 2012 to September 2015, we enrolled 107 women. Out of these, 57 received oral tablet mifepristone (400 mg) and 50 were inserted with balloon catheter. Labor onset after first manoeuvre was statistically significantly more in mifepristone group (37/57 vs. 13/50, respectively; p value 0.000). Bishop Score after 24 h was better in balloon catheter (p value 0.000). More women with balloon catheter required oxytocin for IOL (37/50 vs. 20/57, respectively; p value 0.000) along with higher dose [840 (320) mU vs 560 (120) mU, respectively, p value 0.000]. Failure of induction was statistically significantly higher in balloon catheter group (8 out of 50 vs. 2 out of 57, respectively, p value 0.043). There was no statistically significant difference in normal delivery or CS in either group (p value 0.242 and 0.331, respectively).
Oral mifepristone (400 mg) is associated with statistically significantly higher incidence of labor onset in post date pregnant women with previous one CS, as compared to balloon catheter. Both methods are primarily for cervical ripening and oxytocin should not be delayed in the absence of onset of labor.
Clinical Trials Registry-India, www.ctri.nic.in , CTRI/2012/05/003634.
比较口服米非司酮（400毫克）与经宫颈球囊导管用于有过一次剖宫产史的过期妊娠妇女引产的效果。
在这项随机试验中，对孕周为40周5天、有过一次低位剖宫产史（既往无阴道分娩史）的过期妊娠孕妇，采用口服米非司酮（400毫克）或球囊导管[Foley导管（16F）；球囊内注入30毫升生理盐水]进行引产。24小时和48小时后对她们进行重新评估。如果在任何时候 Bishop评分>6，则行人工破膜，随后静脉滴注缩宫素。该研究的主要结局是首次操作后发动分娩。次要结局是两组的宫颈成熟度、缩宫素的需求、阴道分娩和剖宫产情况。
2012年6月至2015年9月，我们纳入了107名妇女。其中，57名接受口服米非司酮片（400毫克），50名插入球囊导管。米非司酮组首次操作后发动分娩的发生率在统计学上显著更高（分别为37/57和13/50；p值0.000）。24小时后的Bishop评分在球囊导管组更好（p值0.000）。更多使用球囊导管的妇女引产需要使用缩宫素（分别为37/50和20/57；p值0.000），且剂量更高[分别为840（320）毫单位和560（120）毫单位，p值0.000]。球囊导管组引产失败率在统计学上显著更高（分别为50例中的8例和57例中的2例，p值0.043）。两组在顺产或剖宫产方面均无统计学显著差异（p值分别为0.242和0.331）。
与球囊导管相比，口服米非司酮（400毫克）在有过一次剖宫产史的过期妊娠孕妇中，发动分娩的发生率在统计学上显著更高。两种方法主要用于宫颈成熟，在未发动分娩时不应延迟使用缩宫素。
印度临床试验注册中心，www.ctri.nic.in ，CTRI/2012/05/003634 。
