Assessment of comparative efficacy of standard practice of labour with Modified perineal protection Device (MPPD) versus standard practice of labour alone in prevention perineal tear during second Stage of labour amongst Primi Parturient mothers:RCT
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Improvement of Maternal outcome in terms of perineal tear
研究概览
简要总结
This study is a randomized controlled trial, Participants will be selected by simple random sampling technique. Modified perineal protection device will be used for normal labour of primi parturient Mothers and will be compared with normal delivery in terms of maternal and fetal outcome. The Primary outcomes of primi parturient mother will be studied in terms of perineal tear. The secondary outcome of primi parturient mother like ,Hemorrhage, Length of second stage of labour, Incidence of episiotomy, Status of perineal wound, Perineal pain and neonatal outcomes like Birth weight and APGAR score will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Delivery with cephalic presentation
- •During Delivery Fully flexed Head
- •Birth Weight between 2.5 -3.5 kg
- •An understanding of both oral and written information in Hindi, Marathi and English.
排除标准
- •Mothers undergoing emergency caesarean section were excluded.
- •Mother with Breech presentation
- •Mother with high risk pregnancy (hypertension in pregnancy, Diabetes Mellitus , Cephalopelvic Disproportion etc)
- •Mother undergoing instrumental deliveries.(Forceps or Ventouse)
- •Mother participated in this type of study
- •Less than 32 weeks of gestation mother.
结局指标
主要结局
Improvement of Maternal outcome in terms of perineal tear
时间窗: Assessment will be done immediately after delivery and at 6 weeks.
次要结局
- Maternal and neonatal Outcomes(like Hemorrhage, Length of second stage of labour, Incidence of episiotomy, Status of perineal wound, Perineal pain, Sphincter function Urinary incontinence, faecal incontinence)
研究者
Shalini H Moon
Datta Meghe Institute of Higher Education and Research