Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- The duration of the second stage of labor was compared between the study and control groups
研究概览
简要总结
The investigators hypothesized that the application of lubricant gels at the beginning of the active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim of this study is to investigate and confirm this hypothesis through a randomised controlled trial.
All participants in the study received standard routine antepartum care in the delivery room. Obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups.
详细描述
The participants were divided into two groups based on their parity: nulliparous and primiparous. Initially, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups using a computer-generated random number table. In this randomized controlled trial, participant allocation was carried out using a computer program to ensure a randomized and unbiased selection process. The randomization procedure was conducted in a double-blind manner, with the study investigators remaining unaware of the allocation until the conclusion of the study. All participants in the study received standard routine antepartum care in the delivery room. Among all patients, 25 participants were lost to follow-up during the study. Consequently, obstetric lubricant gel was applied to patients in the study groups, which included 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization was performed using a computer program. Accordingly, the study group patients were administered Obstetric gel. The researcher administering Obstetric gel ensured the blinding of healthcare providers and other researchers.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous and primiparous singleton pregnancies between 37 and 41 weeks + six days of gestation and vertex presentation of fetus with an estimated birth weight of 2000 - 4500g were included in the study
排除标准
- •Multiparous pregnancies and women who had ceserean section before and/or contraindication for vaginal delivery were excluded from the study.
结局指标
主要结局
The duration of the second stage of labor was compared between the study and control groups
时间窗: 0 to 240 minutes
The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn.
The duration of the active phase of the first stage of labor was compared between the study and control groups
时间窗: 0 to 600 minutes
The active phase of labor begins when the cervical dilation is between 4-6 cm and refers to the time elapsed until full cervical dilation.
次要结局
- Episiotomy rates(Episiotomy is a technique performed during the second stage of labor.)
研究者
kaan baydemir
Investigator
Ankara University