Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, South-east, Nigeria.
Afr Health Sci. 2022 Sep;22(3):108-116. doi: 10.4314/ahs.v22i3.13.
Drotaverine, a spasmolytic, has been found to have potential to achieve a reduction in the duration of labour and prevent prolonged labour.
To compare the effects of intravenous drotaverine hydrochloride with placebo for shortening the duration of active phase of labour in primigravidas.
A double-blind, placebo-controlled randomized trial of 246 primigravidas in active phase of labour at term was conducted. They were randomly (1:1 ratio) administered intravenous 2 ml (40mg) of drotaverine hydrochloride or 2 ml of Vitamin B complex as placebo. The primary outcome measure was the duration of active phase of labour. The secondary outcome measures were cervical dilatation rate, oxytocin augmentation rate, incidence of prolonged labour, labour pain scores, mode of delivery, maternal and neonatal outcomes.
The mean duration of active phase of labour (hour) was significantly lower in the drotaverine group compared to the control (drotaverine; 6.22 ± 2.41 vs placebo; 8.33 ± 3.56; p <0.001). Also, the cervical dilatation rate (cm/hr) was significantly faster in the drotaverine arm (drotaverine; 1.68 ± 1.02 versus placebo; 1.06 ± 0.53, p <0.001). There was a significantly higher probability of faster delivery among women who were given drotaverine (log-rank test, p < 0.001). The oxytocin augmentation rate, incidence of prolonged labour, labour pain scores, mode of delivery, maternal and neonatal outcomes were not significantly different among the groups.
Drotaverine hydrochloride is effective in shortening the duration of active phase of labour without adverse maternal and neonatal outcomes. However, more evidence is needed to explore its role in active phase of labour among primigravid women. Trial registration number: PACTR201810902005232.
解痉药二氢托啡因被发现具有缩短产程和预防产程延长的潜力。
比较静脉注射盐酸二氢托啡因与安慰剂对初产妇活跃期产程的影响。
对 246 例足月活跃期初产妇进行了一项双盲、安慰剂对照随机试验。他们被随机（1:1 比例）静脉注射 2 毫升（40mg）盐酸二氢托啡因或 2 毫升维生素 B 复合物作为安慰剂。主要结局指标为活跃期产程的持续时间。次要结局指标包括宫颈扩张率、催产素增加率、产程延长发生率、分娩疼痛评分、分娩方式、母婴结局。
与对照组相比，二氢托啡因组活跃期产程（小时）的平均值明显降低（二氢托啡因；6.22 ± 2.41 对安慰剂；8.33 ± 3.56；p <0.001）。此外，二氢托啡因组宫颈扩张率（cm/hr）明显更快（二氢托啡因；1.68 ± 1.02 对安慰剂；1.06 ± 0.53，p <0.001）。给予二氢托啡因的女性分娩速度更快的可能性明显更高（对数秩检验，p <0.001）。催产素增加率、产程延长发生率、分娩疼痛评分、分娩方式、母婴结局在各组之间无显著差异。
盐酸二氢托啡因可有效缩短活跃期产程，且不增加母婴不良结局。然而，需要更多的证据来探讨其在初产妇活跃期中的作用。试验注册号：PACTR201810902005232。
