Abstract：
OBJECTIVE: To compare the labor duration and other maternal and neonatal outcomes between hospitalized women with uncomplicated pregnancies receiving amniotomy at 5 cm cervical dilatation and those not receiving amniotomy.
METHODS: This prospective, randomized controlled trial was conducted at a tertiary hospital between June 2020 and October 2021. The study included low-risk pregnant women with spontaneous onset of labor at term, carrying a single fetus in cephalic presentation and with intact amniotic membranes. When the cervical dilatation reached 5 cm, participants were randomly assigned to receive or not receive amniotomy. Maternal demographics, labor and delivery data, and neonatal outcomes were compared between the two groups.
RESULTS: The amniotomy group had a significantly shorter duration of labor compared with the control group (mean difference 49.4 min, 95% confidence interval [CI] 16.8-81.9, P = 0.003). The following outcomes were not significantly different between the two groups: (1) the need for oxytocin to augment labor; (2) cesarean section rates; (3) the incidence rates of suspected fetal distress and instrumental delivery; and (4) neonatal outcomes.
CONCLUSIONS: Compared with expectant management, amniotomy during the active phase of labor (as newly defined by WHO) can shorten the labor duration without an increased risk of cesarean delivery or other negative consequences. THAI CLINICAL TRIALS REGISTRY (TCTR) (TCTR20200522001): https://www.thaiclinicaltrials.org/show/TCTR20200522001.
METHODS: This prospective, randomized controlled trial was conducted at a tertiary hospital between June 2020 and October 2021. The study included low-risk pregnant women with spontaneous onset of labor at term, carrying a single fetus in cephalic presentation and with intact amniotic membranes. When the cervical dilatation reached 5 cm, participants were randomly assigned to receive or not receive amniotomy. Maternal demographics, labor and delivery data, and neonatal outcomes were compared between the two groups.
RESULTS: The amniotomy group had a significantly shorter duration of labor compared with the control group (mean difference 49.4 min, 95% confidence interval [CI] 16.8-81.9, P = 0.003). The following outcomes were not significantly different between the two groups: (1) the need for oxytocin to augment labor; (2) cesarean section rates; (3) the incidence rates of suspected fetal distress and instrumental delivery; and (4) neonatal outcomes.
CONCLUSIONS: Compared with expectant management, amniotomy during the active phase of labor (as newly defined by WHO) can shorten the labor duration without an increased risk of cesarean delivery or other negative consequences. THAI CLINICAL TRIALS REGISTRY (TCTR) (TCTR20200522001): https://www.thaiclinicaltrials.org/show/TCTR20200522001.
摘要：
目的：比较宫颈扩张5cm羊膜切开术和未羊膜切开术的住院妇女的产程和其他母婴结局。
方法：这种前瞻性，随机对照试验于2020年6月至2021年10月在一家三级医院进行.该研究包括足月自发分娩的低风险孕妇，携带单个胎儿的头颅表现和完整的羊膜。当宫颈扩张达到5厘米时，参与者被随机分配接受或不接受羊膜切开术.孕产妇人口统计，人工和交货数据，比较两组新生儿结局。
结果：与对照组相比，羊膜切开术组的产程明显缩短（平均差异49.4分钟，95%置信区间[CI]16.8-81.9，P=0.003）。两组之间的以下结果没有显着差异：（1）需要催产素以增加分娩；（2）剖宫产率；（3）可疑胎儿窘迫和器械分娩的发生率；（4）新生儿结局。
结论：与预期管理相比，在活产期(WHO新定义)羊膜切开术可以缩短产程,而不会增加剖宫产的风险或其他负面后果.泰国临床试验注册（TCTR）（TCTR20200522001）：https：//www。thaiclinicaltrials.org/show/TCTR20200522001。
方法：这种前瞻性，随机对照试验于2020年6月至2021年10月在一家三级医院进行.该研究包括足月自发分娩的低风险孕妇，携带单个胎儿的头颅表现和完整的羊膜。当宫颈扩张达到5厘米时，参与者被随机分配接受或不接受羊膜切开术.孕产妇人口统计，人工和交货数据，比较两组新生儿结局。
结果：与对照组相比，羊膜切开术组的产程明显缩短（平均差异49.4分钟，95%置信区间[CI]16.8-81.9，P=0.003）。两组之间的以下结果没有显着差异：（1）需要催产素以增加分娩；（2）剖宫产率；（3）可疑胎儿窘迫和器械分娩的发生率；（4）新生儿结局。
结论：与预期管理相比，在活产期(WHO新定义)羊膜切开术可以缩短产程,而不会增加剖宫产的风险或其他负面后果.泰国临床试验注册（TCTR）（TCTR20200522001）：https：//www。thaiclinicaltrials.org/show/TCTR20200522001。
