Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Blood loss 500 ml or more after enrolment
研究概览
简要总结
the investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of additional uterotonics and need for blood transfusion.
详细描述
the investigators conduct a prospective non- randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since April 2014 till May 2016, after approval of the study protocol by the Local Ethical Committee. A written informed consent is obtained from eligible women before induction or at early stage of labour.
Women with singleton pregnancies of more than 28 weeks' gestation who are admitted to hospital and candidates for vaginal delivery are eligible for the study .Gestational age more than 28 weeks the gestational age is determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester.
The patients (520) are divided into two groups, Group A (260) receive bimanual uterine compression immediately after delivery of the placenta for 5 minutes while Group B (260) receive no intervention.
The third stage of labour was managed as usual by clamping and cutting of umbilical cord, waiting for signs of placental separation and delivering the placenta by controlled cord traction.
Duration of the 3rd stage of labour is calculated. Patients are kept in labor room under observation for a period of 1 h.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester
- •Women at high risk for primary atonic postpartum hemorrhage
- •Over distended uterus
- •Large fetus
- •Multiple fetuses
- •Hydramnios
- •Distension with clots accidental hemorrhage
- •Exhausted myometrium
- •Prolonged labor
- •Oxytocin or prostaglandin stimulation
- •Chorioamnionitis
- •Previous uterine atony
- •Placenta previa
- •Marked anemia
排除标准
- •Cervical tear
- •extensive birth canal tear
- •Postpartum hemorrhage
- •Retained placenta
- •Coagulopathy
- •Chronic medical illness hepatic renal
- •Pregnancy induced hypertension PIH
- •Refusal to participate in the study
结局指标
主要结局
Blood loss 500 ml or more after enrolment
时间窗: 60 minutes after enrolment
estimating blood loss from vagina
次要结局
- Blood loss 1000 ml or more after enrolment((up to 30 and 60 minutes) after enrolment)
- Blood transfusion(60 minutes)
- Use of additional uterotonics or other procedures(60 minutes)
研究者
khalid abd aziz mohamed
lecturer of ob/gyn
Benha University