Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use in the third stage of labor ineffective in reducing post partum blood loss as compared to other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in reducing post partum hemorrhage.
详细描述
Our study will be carried out at Makassed General Hospital, a tertiary-level maternity unit performing about 1000 deliveries annually. After approval by the hospital Ethics and Research Committee, women with single viable pregnancy, in cephalic presentation, at full term and whom labor was induced by Oxytocin will be eligible for inclusion.
After informed consents is obtained, the parturients will be assigned randomly according to a computer generated sequence in block lists of 25each time to receive either 1000mcg of Misoprostol rectally or 20 units of Oxytocin intravenously to run at a rate of 150ml/hr. The medications will be given just after cord clamping and before delivery of the placenta. Active management of the third stage of labor will be carried out simultaneously with early cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine massage in addition to the uterotonic according to assignment of the patient. Assessment of the uterine condition will be done by the obstetrician or his assistant, together with visually estimating the amount of blood loss. Once uterine atony or estimated blood loss (EBL) of more than 500 ml is noticed, another uterotonics will be administered according to the condition and at the discretion of the obstetrician.
Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH) by the routine uterine massage will urge the use of either different uterotonics or surgical intervention if necessary. Blood transfusion will be ordered for the cases whose visual estimation of blood loss is more than 1000ml or when the patient was hemodynamically unstable. In order to compare the effect of each medication alone on the amount of blood loss, we will then exclude those patients who received blood transfusion or additional uterotonics. A base line hemoglobin and hematocrit levels will be withdrawn on admission and another reading 12 hours postpartum.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with single viable pregnancy,
- •cephalic presentation,
- •at full term
- •whom labor was induced by Oxytocin were eligible
排除标准
- •delivery by cesarean section
- •received other prophylactic uterotonics
研究组 & 干预措施
Misoprostol
Rectal misoprostol
干预措施: Misoprostol after delivery (Drug)
Misoprostol
Rectal misoprostol
干预措施: Oxytocin before delivery (Drug)
Oxytocin
intravenous oxytocin
干预措施: Oxytocin after delivery (Drug)
Oxytocin
intravenous oxytocin
干预措施: Oxytocin before delivery (Drug)
结局指标
主要结局
Hemoglobin level
时间窗: 12 to 24 hours post partum
10% or more drop in hemoglobin
次要结局
- mean hemoglobin drop(12 to 24 hours post partum)
- drop in hemoglobin(12 to 24 hours post partum)
- mean estimated blood loss(during the first hour post partum)
- side effect of medication(upto 48 hours after delivery)
研究者
Manal Hubeish
OBGYN attending physician
Makassed General Hospital