Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Number of patients with perineal tear
研究概览
简要总结
There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery.
According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.
Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.
详细描述
Various techniques have been developed to prevent the development of perineal tears. As reported in the literature, active protection of the perineum during the second stage of labor can reduce the rate of tears. These include massage of the perineum, hands-on technique, use of gel, and warm compresses.
According to a Cochrane review that examined the use of warm compresses published in 2017, there is no difference in terms of the rate of events of an intact perineum, perineal trauma that requires suturing, but in a subanalysis it showed that there is a decrease in the rate of advanced tears, involving the anal sphincter and the rectal mucosa (grade three and four).
According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.
Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term pregnancy
- •Singleton pregnancy
- •Vertex presentation
排除标准
- •Women with a history of third degree perineal tear in the past
- •Intrauterine fetal death
- •Crohn disease with perineal involvement
结局指标
主要结局
Number of patients with perineal tear
时间窗: 2 years
Perineal tear (spontaneous) that required suturing
次要结局
- Number of patients with mild perineal tear(2 years)
- Number of patients with with advanced perineal tear(2 years)
- Number of patients with episiotomy(2 years)
研究者
Dr Raneen Abu Shqara
Principal investigator, clinical instructor
Western Galilee Hospital-Nahariya