Obstetric Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial.

IF 2.7 4区 医学 Q2 OBSTETRICS & GYNECOLOGY
Elie Hobeika, Ihab M Usta, Labib Ghulmiyyah, Ghina Ghazeeri, Hani Tamim, Anwar H Nassar
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引用次数: 0

Abstract

Objectives: Vaginal delivery is associated with numerous forms of lower genital tract trauma. Several practices were developed to decrease the duration of the second stage of labor and the likelihood of lower genital tract trauma. Applying obstetric gel is one practice that has been studied in literature, with insufficient and somewhat conflicting evidence. The aim of this study was to compare the duration of the first and second stages of labor, and the integrity of lower genital tract, with or without the application of obstetric gel.

Design: A randomized controlled trial was conducted, where delivering women were randomly assigned, based on individual stratifications, to receive either standard care during labor and delivery (n = 82), or with the additional application of the obstetric gel (n = 78).

Participants/materials, setting, methods: A specifically designed sterile obstetric gel (Natalis®) was applied in the intervention group starting with the first vaginal examination after admission, with a total of 20-30 mL administered per childbirth. Descriptive and inferential statistics were implemented to describe the sample and compare outcomes across the intervention and the control groups, which were further divided depending on their parity (nulliparous and multiparous). The primary outcome was the duration of the second stage of labor.

Results: A total of 160 women were recruited. The obstetric gel did not significantly shorten the duration of the first and second stages of labor, among other labor outcomes. However, an underpowered subgroup analysis showed that nulliparas who had obstetric gel application have had a significantly shorter duration of the second stage of labor compared with the control group (69.5 ± 45.3 vs. 97.5 ± 54.3 min; p value = 0.041).

Limitation: A major limitation in our clinical trial is the small sample size that didn't account for subgrouping of parity when estimating the study's power.

Conclusions: The obstetric gel did not incur statistically significant effect on labor outcomes including the duration of the second stage of labor. While being underpowered, nulliparas in the intervention group had a shorter duration of the second stage of labor than the control group. The lack of certainty in our results calls for more research to tackle this problem with adequate power to conclude valid results and to further confirm our subgroup findings in order to consider utilizing this practice that aims at improving the delivery experience.

产科凝胶用于缩短产程和预防下生殖道创伤:一项随机对照试验。
目的:阴道分娩与多种形式的下生殖道创伤有关。一些做法是发展,以减少持续时间的第二阶段的劳动和可能性的下生殖道创伤。应用产科凝胶是文献中研究的一种实践,证据不足,有些相互矛盾。本研究的目的是比较第一和第二产程的持续时间,以及下生殖道的完整性,有或没有应用产科凝胶。设计:进行了一项随机对照试验,分娩妇女根据个体分层随机分配,在分娩和分娩期间接受标准护理(n = 82),或额外应用产科凝胶(n = 78)。参与者/材料、环境、方法:干预组从入院后第一次阴道检查开始使用专门设计的无菌产科凝胶(Natalis),每次分娩共使用20-30 mL。采用描述性和推断性统计来描述样本,并比较干预组和对照组的结果,对照组根据胎次(无胎和多胎)进一步划分。主要观察指标是第二产程的持续时间。结果:共招募了160名女性。产科凝胶并没有显著缩短第一和第二产程的持续时间,以及其他分娩结果。然而,一项动力不足的亚组分析显示,与对照组相比,使用产科凝胶的产妇第二产程持续时间明显缩短(69.5±45.3分钟vs 97.5±54.3分钟;p值= 0.041)。局限性:我们临床试验的一个主要局限性是样本量小,在估计研究的威力时没有考虑到奇偶次分组。结论:产科凝胶对分娩结局(包括第二产程持续时间)没有统计学上的显著影响。在动力不足的情况下,干预组的产妇在第二产程的持续时间比对照组短。我们的结果缺乏确定性,需要更多的研究来解决这个问题,以足够的力量得出有效的结果,并进一步确认我们的小组发现,以便考虑利用这一实践,旨在改善交付体验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.20
自引率
4.80%
发文量
44
审稿时长
6-12 weeks
期刊介绍: This journal covers the most active and promising areas of current research in gynecology and obstetrics. Invited, well-referenced reviews by noted experts keep readers in touch with the general framework and direction of international study. Original papers report selected experimental and clinical investigations in all fields related to gynecology, obstetrics and reproduction. Short communications are published to allow immediate discussion of new data. The international and interdisciplinary character of this periodical provides an avenue to less accessible sources and to worldwide research for investigators and practitioners.
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