Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Frequency of episiotomy
概览
简要总结
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons Pakistan approval, to assess whether intrapartum perineal massage reduces mediolateral episiotomy and lowers the frequency and severity of perineal tears in women undergoing term (37-42 weeks), singleton, cephalic vaginal delivery. Women aged 18-45 years in active labour who provided written informed consent were consecutively enrolled and randomized (1:1) by a computer-generated sequence with sequentially numbered, opaque, sealed envelopes to either standard intrapartum care or standard care plus perineal massage; women with conditions requiring urgent delivery/caesarean section or contraindicating vaginal delivery/perineal manipulation were excluded. In the intervention arm, a trained doctor performed standardized perineal massage using sterile water-based lubricant during the first stage and again near the second stage, with predefined stopping criteria for safety; the control arm received routine care without massage beyond usual perineal support at delivery. Primary outcomes were episiotomy (Yes/No) and perineal tear occurrence and grade (first-fourth), assessed immediately post-delivery by a consultant obstetrician not involved in providing massage.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-45 years
- •Primigravida and multigravida women in active labor.
- •Singleton, cephalic presentation of the fetus.
- •Women who provide informed consent to participate in the study.
- •Women at Term pregnancy (37 - 42 weeks).
排除标准
- •Women with placental abruption, vaginal bleeding, macrosomia, fetal distress, vaginal infections, placenta previa and preterm births.
- •Non-vertex fetal presentations such as breech.
- •Women scheduled for a cesarean section.
- •Pregnancies with multiple gestations (e.g., twins, triplets).
- •Presence of active genital herpes or other contraindications to vaginal birth (HIV).
- •Active vaginal infections, including bacterial vaginosis or yeast infections.
研究组 & 干预措施
Intrapartum Perineal Massage Group
Women received routine intrapartum care plus standardized intrapartum perineal massage performed by a trained doctor during the first stage of labour (repeated sessions) and an additional session as the second stage approached, using a sterile water-based obstetric lubricant.
干预措施: Intrapartum perineal massage (Procedure)
Control Group
Standard Intrapartum Care
干预措施: Standard Intrapartum Care Group (Control) (Other)
结局指标
主要结局
Frequency of episiotomy
时间窗: Immediately at the time of delivery (during second stage and recorded immediately after birth)
Proportion of participants in whom a mediolateral episiotomy was performed during vaginal delivery, based on predefined clinical indications and documented by the consultant obstetrician.
Frequency of perineal tears
时间窗: Immediately after birth (post-delivery examination in the labour room)
Proportion of participants with any spontaneous perineal laceration after vaginal delivery, determined on systematic post-delivery perineal and vaginal examination by the consultant obstetrician.
次要结局
未报告次要终点
研究者
Kainat usman
Principal Investigator
Sheikh Zayed Medical College