Kashanian Maryam, Shirvani Shaghayegh, Sheikhansari Narges, Javanmanesh Forough
Department of Obstetrics and Gynecology, Iran University of Medical Sciences, Tehran, Iran.
Faculty of Medicine, University of Exeter, Exeter, United Kingdom.
J Matern Fetal Neonatal Med. 2020 Oct;33(19):3215-3220. doi: 10.1080/14767058.2019.1570117. Epub 2019 Jan 29.
Preterm delivery is an important issue in obstetrics, which is the most common cause of neonatal mortality and morbidity. Therefore, finding a way to prevent it is always under serious concern. The study aimed to compare the efficacy of two tocolytic agents, nifedipine and indomethacin, for inhibiting preterm uterine contractions as monotherapy and combination therapy. A double-blind randomized clinical trial was performed on pregnant women with gestational age of 26-34 weeks of pregnancy who referred to hospital for preterm labor. They were randomly assigned to three groups. Indomethacin plus placebo, nifedipine plus placebo, and a combination of indomethacin and nifedipine were administered to the three groups. Inhibiting contractions for 2 hours and prevention of delivery for 48 hours and 7 days were evaluated. Also, duration of pregnancy, the number of preterm births, and the interval between entering the study and delivery were compared between three groups. One hundred fifty women were eligible for the study. Two women in the nifedipine group and one woman in the combined group were excluded from the study because of hypotension. The women of the three groups did not have significant difference according to age, BMI, gravidity, parity, Bishop score, gestational age, and the number of contractions at entering the study. Thirty-six women (72%) in the indomethacin group, 36 women (72%) in the nifedipine group, and 41 women (89.4%) in the combination group had stopped contractions within the first 2 hours of intervention ( = .002). Inhibiting contractions for 48 hours ( = .003), inhibiting contractions for 7 days ( = .021), gestational age at birth ( = .001), number of pregnancies more than 37 weeks ( = .007), and neonatal weight ( = .020) were significantly more in the combination group. Combination therapy with nifedipine and indomethacin was more effective than monotherapy with either of these two medications for inhibiting preterm labor, delaying delivery, and prolongation of the duration of pregnancy.
早产是产科中的一个重要问题，它是新生儿死亡和发病的最常见原因。因此，找到预防早产的方法一直备受关注。该研究旨在比较两种宫缩抑制剂硝苯地平与吲哚美辛作为单一疗法和联合疗法抑制早产宫缩的疗效。对妊娠26 - 34周因早产而入院的孕妇进行了一项双盲随机临床试验。她们被随机分为三组。三组分别给予吲哚美辛加安慰剂、硝苯地平加安慰剂以及吲哚美辛与硝苯地平联合用药。评估干预2小时内宫缩的抑制情况以及48小时和7天内分娩的预防情况。此外，还比较了三组之间的妊娠持续时间、早产次数以及进入研究至分娩的间隔时间。150名女性符合该研究条件。硝苯地平组有两名女性和联合用药组有一名女性因低血压被排除在研究之外。三组女性在年龄、体重指数、孕次、产次、Bishop评分、孕周以及进入研究时的宫缩次数方面没有显著差异。吲哚美辛组36名女性（72%）、硝苯地平组36名女性（72%）以及联合用药组41名女性（89.4%）在干预的前2小时内宫缩停止（P = 0.002）。联合用药组在48小时内抑制宫缩（P = 0.003）、7天内抑制宫缩（P = 0.021）、出生时的孕周（P = 0.001）、孕周超过37周的妊娠次数（P = 0.007）以及新生儿体重（P = 0.020）方面均显著更高。硝苯地平和吲哚美辛联合疗法在抑制早产宫缩、延迟分娩以及延长妊娠持续时间方面比这两种药物中的任何一种单一疗法都更有效。
