Perineal Massage and Warm Compresses During Second Stage of Labor - Randomised Controlled Trial for Reduce Perineal Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Intact Perineum
研究概览
简要总结
The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.
详细描述
A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomization envelope was opened by the midwife when the participant entered the second stage of labor and was destroyed thereafter. The allocation was only shown to the midwife and if necessary, the obstetrician. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on). The participants were blinded to their allocation. After the placenta delivery, a blinded midwife not otherwise involved in the birth but trained, assessed the perineum (graded the perineal tears). The data about the variables included in the study were registered by the midwife responsible for the birth. Midwives who assess the primary outcomes and the principal investigator were blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with 18 years or older
- •Between 37 and 41 weeks of pregnancy
- •Expected spontaneous vaginal birth
- •Fetus in the cephalic presentation
- •Able to provide informed written consent
排除标准
- •Multiple pregnancy
- •Meconial amniotic fluid
- •Fetal distress
- •Suspicion of fetal growth restriction
- •Gestational hypertensive disorders
结局指标
主要结局
Intact Perineum
时间窗: up to 10 minutes after childbirth
Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)
First-degree perineal tear
时间窗: up to 10 minutes after childbirth
Skin and vaginal tear
Second-degree perineal tear
时间窗: up to 10 minutes after childbirth
Skin and muscle tear (posterior compartment)
OASIS
时间窗: up to 10 minutes after childbirth
Obstetric anal sphincter injuries (Third-degree tears (injury of anal sphincter) and Fourth-degree tears (Injury of anal sphincter and the anal canal or rectum) without episiotomy
OASIS + episiotomy
时间窗: up to 10 minutes after childbirth
Third and fourth degree tear with episiotomy
Episiotomy
时间窗: up to 10 minutes after childbirth
without spontaneous perineal trauma or vaginal tears
Episiotomy and second degree tear
时间窗: up to 10 minutes after childbirth
Episiotomy and spontaneous skin and muscle tear
OASIS with/without episiotomy
时间窗: up to 10 minutes after childbirth
with and without episiotomy
Vaginal tears
时间窗: up to 10 minutes after childbirth
only vaginal tear
Episiotomy and first degree tear
时间窗: up to 10 minutes after childbirth
Episiotomy with spontaneous skin tear
Anterior Compartment tears
时间窗: up to 10 minutes after childbirth
Without episiotomy or any other degree of perineal trauma
次要结局
- Admission to Neonatal Intensive Unit Care(up to 2 hours after childbirth)
- Apgar 5 minutes(5 minutes after childbirth)
- Recommend an intervention allocated to a friend(24 hours after childbirth)
- Pelvic Floor Dysfunction symptoms(24 hours, 3 months and 6 months after childbirth)
- Maternal satisfaction with intervention(24 hours after childbirth)
- Maternal Pain(24 hours, 3 months and 6 months after childbirth)
- Female Sexual Function Index score(24 hours, 3 months and 6 months after childbirth)
- Breastfeeding(24 hours, 3 months and 6 months after childbirth)
研究者
Sílvia Leite Rodrigues
Principal Investigator
Universidade do Porto