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一项关于长程产程初产妇应用氢溴酸东莨菪碱对产程影响的随机对照研究。

A randomized controlled study of the effect of hyoscine butylbromide on duration of labor in primigravida women with prolonged labor.

机构信息

Obstetrics and Gynecology Department, Kasr AlAini Hospital Cairo University, 11 Eid Mostafa from King Faisal Street Haram Giza, Cairo, 12111, Egypt.

出版信息

Arch Gynecol Obstet. 2021 Dec;304(6):1513-1518. doi: 10.1007/s00404-021-06087-7. Epub 2021 May 13.

Abstract

OBJECTIVE

To assess the safety and efficacy of hyoscine butyl bromide (HBB) in primipara with prolonged 1st stage of labor.

MATERIALS AND METHODS

A double-blinded randomized controlled trial included 100 primiparas diagnosed with prolonged labor. They were randomly divided two equal groups. Group I received 40 mg HBB intravenously. Group II received 2 ml of normal saline. The primary outcome was the duration of the 1st stage of labor. Secondary outcomes included success of vaginal delivery, rate of cervical dilation, duration of 2nd and 3rd stages of labor, causes of CS, neonatal outcome and drug side effects.

RESULTS

The duration of the 1st stage was 322.3 ± 89.8 min in women who received HBB compared with 451.3 ± 198.3 min in the control women (P < 0.001). The rate of cervical dilation was increased from 0.4 ± 0.2 to 1.5 ± 0.6 in women who received HBB compared with its increase from 0.4 ± 0.1 to 0.9 ± 0.2 in other women (P < 0.001). The rate of CS were significantly higher in control women when compared to those received HBB (34 vs. 20%, P < 0.001). The commonest indication for the operation was arrest of cervical dilatation (28 and 16%, respectively).

CONCLUSION

HBB is associated with shortening of the 1st stage, lowered rate of CS without any side effects.

GOV ID

NCT03430362 date of registration 6 February 2018. Synopsis Hyoscine butyl bromide is associated with shortening of the 1st stage, lowered rate of CS in primiparas with prolonged labor.

摘要

目的

评估氢溴酸东莨菪碱(HBB)在产程延长的初产妇中的安全性和有效性。

材料与方法

一项双盲随机对照试验纳入了 100 例诊断为产程延长的初产妇。将其随机分为两组,每组 50 例。I 组产妇静脉注射 40mg HBB,II 组产妇静脉注射 2ml 生理盐水。主要结局是第一产程的持续时间。次要结局包括阴道分娩成功率、宫颈扩张率、第二产程和第三产程持续时间、剖宫产原因、新生儿结局和药物副作用。

结果

接受 HBB 的产妇第一产程持续时间为 322.3±89.8min,而对照组产妇为 451.3±198.3min(P<0.001)。接受 HBB 的产妇宫颈扩张率从 0.4±0.2 增加到 1.5±0.6,而对照组产妇从 0.4±0.1 增加到 0.9±0.2(P<0.001)。与接受 HBB 的产妇相比,对照组产妇行剖宫产术的比例显著更高(34%比 20%,P<0.001)。手术最常见的指征是宫颈扩张停止(分别为 28%和 16%)。

结论

HBB 可缩短第一产程,降低剖宫产率,且无任何副作用。

政府标识符

NCT03430362 注册日期 2018 年 2 月 6 日。摘要 氢溴酸东莨菪碱可缩短初产妇产程延长的第一产程,降低剖宫产率。

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