Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 2
- 主要终点
- Vaginal bleeding during the 1st 24 hours postoperative.
研究概览
简要总结
obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries. Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development.
Some obstetricians believe that the cervix of women at non-labor cesarean section is undilated and might cause obstruction of blood or lochia drainage, leading to postpartum hemorrhage and endometritis from the collection of lochia or debris. Dilatation of the cervix helps with the drainage of blood during postpartum, reducing intrauterine infection or the risk of postpartum hemorrhage. To avoid this problem, some obstetricians routinely dilate the cervix from above during an elective/ non-labor cesarean section using finger, sponge forceps or other instruments
详细描述
Obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries.
Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development. Obstetric hemorrhage encompasses both antepartum and postpartum bleeding.
The direct pregnancy-related maternal mortality rate in the United States is approximately 7-10 women per 100,000 live births. National statistics suggest that approximately 8% of these deaths are caused by Post Partum Hemorrhage (PPH).
In industrialized countries, PPH usually ranks in the top 3 causes of maternal mortality, along with embolism and hypertension. In the developing world, several countries have maternal mortality rates in excess of 1000 women per 100,000 live births, and World Health Organization statistics suggest that 25% of maternal deaths are due to PPH, accounting for more than 100,000 maternal deaths per year . The most recent Practice Bulletin from the American College of Obstetricians and Gynecologists places the estimate at 140,000 maternal deaths per year or 1 woman every 4 minutes. The rate of PPH increased from 1.5% in 1999 to 4.1% in 2009, and the rate of atonic PPH rose from 1% in 1999 to 3.4% in 2009. In the triennium 2006-2008, 261 women in the UK died directly or indirectly related to pregnancy. The overall maternal mortality rate was 11.39 per 100,000 maternities. Direct deaths decreased from 6.24 per 100,000 maternities in 2003-2005 to 4.67 per 100,000 maternities in 2006-2008 (p = 0.02). The number of deaths from postpartum hemorrhage (PPH) has halved to five.
In many countries cesarean section (CS) has become the mode of delivery in over a quarter of all births. It is the most commonly performed operation in obstetrics.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The included patients will be randomized using sealed opaque envelope method into two groups
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with a single term fetus >37 weeks of gestational age, with American Society of Anesthesiology (ASA) physical status I or II undergoing Elective Cs (primary or repeated CS).
- •Age group 20 - 35 years old
排除标准
- •Chorioamnionitis.
- •Placenta previa.
- •Multiple gestations.
- •Preeclampsia.
- •Macrosomia.
- •Hydramnios.
- •Uterine leiomyomata.
- •Previous cervical surgery.
- •Previous post-partum hemorrhage.
- •Bleeding tendency.
- •Hypertension.
- •Diabetes mellitus.
结局指标
主要结局
Vaginal bleeding during the 1st 24 hours postoperative.
时间窗: the 1st 24 hours postoperative.
The amount of vaginal bleeding will be calculated according to number of soaked pads used after the cesarean section for the 1st 24 hours. Where each soaked pad = 50 cc
次要结局
- Total blood loss(operation time plus the 1st 24 hours after operation)
- intraoperative blood loss(during the time of the operation)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University