Kashanian Maryam, Bahasadri Shohreh, Nejat Dehkordy Ashraf, Sheikhansari Narges, Eshraghi Noushin
Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital, Tehran, Iran.
National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.
Med J Islam Repub Iran. 2019 Oct 28;33:115. doi: 10.34171/mjiri.33.115. eCollection 2019.
Different methods of cervical ripening and induction of labor have been used in the cases of unfavorable cervix with different levels of success, but no method has been found to be the best option. The purpose of the present study was to find the effects and side effects of three different methods of cervical ripening and induction of labor. These three methods were oral titrated misoprostol, constant dose of oral misoprostol and Foley catheter with extra-amniotic saline infusion. This clinical trial was performed on women with unfavorable cervix who had been admitted in Akbarabadi Teaching Hospital for induction of labor and had bishop score of less than six; between March 2014- March 2015. The eligible women were assigned into three groups. In titrated oral misoprostol group (n=33), titrated solution of misoprostol, and in oral misoprostol group (n=33), 50µg oral misoprostol every four hours and in Foley catheter group (n=50), Foley catheter with extra-amniotic saline infusion were administered. The main outcome was the number of vaginal deliveries during the first 24 hours. In addition, number of cesarean deliveries and adverse effects were compared between the three groups. The obtained data were analyzed using SPSS 18 software. Data analysis was performed according to the intention to treat principle. Chi-square test, Fisher Exact test, Student ttest, and Mann-Whitney U test, were used for comparing data. P-value≤0.05 was considered statistically significant. The three groups did not have any significant difference according to maternal age, gestational age at the time of admission, gravidity, parity, and primary Bishop Score. There was no significant difference between the three groups for the main outcome, which was vaginal delivery during the first 24 hours (p=0.887). There was no significant difference between the three groups according to hypertonicity, uterine hyperstimulation, meconium passage, non-reassuring fetal heart rate, neonatal Apgar score in minutes one and 5, and mean duration of beginning the intervention up to delivery. However, uterine tachysystole and NICU admission were more in the group to whom the titrated solution of misoprostol was administered (p=0.002 and p=0.037 respectively). The number of cesarean deliveries due to failure to progress was higher in the EASI group. However, EASI group showed the least number of none-reassuring fetal heart rate between the three groups. Meconium passage was more in the titrated misoprostol group, but the difference was not significant. All three methods are appropriate methods for induction of labor in the cases of unfavorable cervix; and choosing each method depends on the expertise of labor staff, accessibility to the medications, cost, and taking care for monitoring the patients and adverse effects.
对于宫颈条件不佳的情况，已采用不同的宫颈成熟和引产方法，且成功率各异，但尚未发现哪种方法是最佳选择。本研究的目的是探究三种不同的宫颈成熟和引产方法的效果及副作用。这三种方法分别是口服滴定米索前列醇、固定剂量口服米索前列醇以及带羊膜腔外生理盐水输注的 Foley 导管法。这项临床试验针对宫颈条件不佳且入住阿克巴拉巴迪教学医院进行引产、Bishop 评分低于 6 分的女性开展，时间为 2014 年 3 月至 2015 年 3 月。符合条件的女性被分为三组。在滴定口服米索前列醇组（n = 33）中，给予滴定的米索前列醇溶液；在口服米索前列醇组（n = 33）中，每四小时口服 50µg 米索前列醇；在 Foley 导管组（n = 50）中，给予带羊膜腔外生理盐水输注的 Foley 导管。主要结局是前 24 小时内的阴道分娩次数。此外，还比较了三组之间的剖宫产次数及不良反应。使用 SPSS 18 软件对所得数据进行分析。数据分析按照意向性分析原则进行。采用卡方检验、Fisher 精确检验、学生 t 检验和 Mann-Whitney U 检验来比较数据。P 值≤0.05 被认为具有统计学意义。三组在产妇年龄、入院时孕周、孕次、产次和初始 Bishop 评分方面无显著差异。三组在前 24 小时内阴道分娩这一主要结局方面无显著差异（p = 0.887）。在子宫收缩过强、子宫过度刺激、胎粪排出、胎儿心率异常、出生后 1 分钟和 5 分钟的新生儿 Apgar 评分以及从开始干预到分娩的平均持续时间方面，三组之间无显著差异。然而，给予滴定米索前列醇溶液的组中子宫收缩过速和新生儿重症监护病房（NICU）入院率更高（分别为 p = 0.002 和 p = 0.037）。因产程无进展而行剖宫产的次数在 EASI 组更高。不过，EASI 组在三组中胎儿心率异常的情况最少。胎粪排出在滴定米索前列醇组中更多，但差异不显著。所有三种方法都是宫颈条件不佳时引产的合适方法；选择每种方法取决于产科工作人员的专业技能、药物可及性、成本以及对患者和不良反应监测的关注程度。
