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临床试验/NCT01571323
NCT01571323已完成1 期

Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section

Qazvin University Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
150
试验地点
1
主要终点
changes in hemoglobin levels after delivery

研究概览

简要总结

The purpose of this study is to demonstrate that the combined used of low dose of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 50 each. The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate . The main outcome measures were blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and added to volume from suction bottle. Hemoglobin values were determined both before surgery and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during surgery .The need for additional oxytocic therapy, operating time, infusion volume given intraoperatively, need for blood transfusion, side effects of study drug and any significant puerperal morbidity were also recorded.

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 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section

排除标准

  • women with any risk factor
  • associated with an increased risk of postpartum
  • hemorrhage were excluded i.e. anemia (Hb8 g%), multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus.
  • current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy

研究组 & 干预措施

Misoprostol

Active Comparator

干预措施: Misoprostol (Drug)

Oxytocin

Active Comparator

干预措施: Oxytocin (Drug)

Oxytocin and Misoprostol

Active Comparator

干预措施: Oxytocin and Misoprostol (Drug)

结局指标

主要结局

changes in hemoglobin levels after delivery

时间窗: Hemoglobin values will be determined both before surgery and 24 h following surgery

次要结局

  • Hemodynamic variables(every 5 minutes during surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

marzieh beigom khezri

assistant professor

Qazvin University Of Medical Sciences

研究点 (1)

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