NCT02509351已完成2 期
Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- volume of intraoperative blood loss
研究概览
简要总结
- Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
- The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin
详细描述
Research question:
In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?
Research hypothesis:
pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •38-41 weeks of amenorrhea
- •scheduled for elective lower segment cesarean section
排除标准
- •confirmed intrauterine fetal death
- •more than previous 2 ceserean sections
- •multiple pregnancy
- •antepartum haemorrhage
- •self-reported maternal heart disease
- •current diagnosis of severe malaria or acute bacterial infection
研究组 & 干预措施
misoprostol
Experimental
women receiving pre-operative rectally administered 400 microgram misoprostol
干预措施: misoprostol (Drug)
placeboo
Active Comparator
women receiving placebo
干预措施: placeboo (Drug)
结局指标
主要结局
volume of intraoperative blood loss
时间窗: 30 minute
volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor
次要结局
- mean measured blood loss(1, 2, and 24 h postpartum)
- maternal mortality(6 months)
- mean postpartum hematocrit(24 hours)
- requirement for blood transfusion(24 hours)
- placental retention(30 minutes)
- requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures(24 hours)
- postpartum hemoglobin(24 hours)
研究者
Ahmed Mohamed El Kotb Abdel Fattah
doctor
Ain Shams University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home BirthsPostpartum HaemorrhageNCT01485562Gynuity Health Projects84
已完成
2 期
Randomized double blind placebo-controlled clinical trial comparison vaginal with sublingual misoprostol in preoperative ripening of the cervix before operative -diagnostic hysteroscopy in premenopausal women in Mirzakuchak-khan hospital at 2010-2011Hysteroscopy.Non inflammatory disorder of cervix uteri, unspecifiedIRCT201012272576N3Vice chancellor for research., Tehran university of medical science100
已完成
2 期
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis (CONVERT)Prevention of Thromboembolic Events in ESRD Patients on Hemodialysis Who Are at Risk for Thromboembolic Events.JPRN-jRCT2080225371Bayer Yakuhin, Ltd.859
已完成
不适用
Randomized double blind trial for inhibitory effect of sulindac and etodorac on aberrant crypt foci (ACF)JPRN-C0000001004th Department of Internal Medicine, Sapporo Medical University School of Medicine360
进行中（未招募）
1 期
A study of the effects of OSU6162 on chronic fatigue in patients who suffered a mild traumatic brain injuryMental fatigue after traumatic brain injuryEUCTR2011-004990-10-SESahlgrenska Academy60