Department of Obstetrics and Gynaecology, Olabisi Onabanjo University, Ago Iwoye, Nigeria.
Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.
Int J Gynaecol Obstet. 2021 May;153(2):254-259. doi: 10.1002/ijgo.13444. Epub 2020 Dec 2.
To assess the effectiveness of hyoscine-N-butylbromide on the duration of the first stage of labor among nulliparous women.
A randomized double-blind placebo-controlled study among 126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018. Based on the inclusion criteria, women were recruited and randomized to the study or control group, and given intravenous hyoscine-N-butylbromide 20 mg (1 mL) or sterile water (1 mL), respectively, during the active phase. Labor progress and outcomes were compared between the groups.
The mean ± SD duration of active phase of first stage of labor was significantly shorter in the hyoscine-N-butylbromide group (324.9 ± 134.6 min) than in the control group (392.7 ± 119.6 min) (P = 0.004). The rate of cervical dilatation was 1.4 ± 0.8 cm/h in the hyoscine-N-butylbromide group and 1.0 ± 0.5 cm/h in the control group (P = 0.004). There were no significant differences in fetal heart rate, maternal vital signs, or Apgar scores between the two groups.
Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate. The trial was registered with the Pan African Clinical trials Registry (PACTR), protocol number: PACTR201808146688942 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3532).
评估氢溴酸东莨菪碱对初产妇第一产程持续时间的影响。
这是一项在尼日利亚萨盖姆一所教学医院进行的随机、双盲、安慰剂对照研究,共纳入 126 名初产妇,纳入时间为 2018 年 1 月至 8 月。根据纳入标准,将产妇招募并随机分为研究组或对照组,分别在活跃期内静脉注射氢溴酸东莨菪碱 20mg(1mL)或无菌水(1mL)。比较两组产妇的产程进展和结局。
氢溴酸东莨菪碱组产妇活跃期第一产程的平均持续时间(324.9±134.6 分钟)显著短于对照组(392.7±119.6 分钟)(P=0.004)。氢溴酸东莨菪碱组宫颈扩张速度为 1.4±0.8cm/h,对照组为 1.0±0.5cm/h(P=0.004)。两组产妇的胎儿心率、母体生命体征或 Apgar 评分均无显著差异。
氢溴酸东莨菪碱能有效缩短第一产程持续时间,且对母婴无不良结局。本试验已在非洲临床试验注册中心(PACTR)注册,编号:PACTR201808146688942(https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3532)。