Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin
- Conditions
- Prevention of Post Partum Hemorrhage After Labor Induction
- Interventions
- Registration Number
- NCT02983591
- Lead Sponsor
- Makassed General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- women with single viable pregnancy,
- cephalic presentation,
- at full term
- whom labor was induced by Oxytocin were eligible
- delivery by cesarean section
- received other prophylactic uterotonics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol Misoprostol after delivery Rectal misoprostol Misoprostol Oxytocin before delivery Rectal misoprostol Oxytocin Oxytocin after delivery intravenous oxytocin Oxytocin Oxytocin before delivery intravenous oxytocin
- Primary Outcome Measures
Name Time Method Hemoglobin level 12 to 24 hours post partum 10% or more drop in hemoglobin
- Secondary Outcome Measures
Name Time Method mean hemoglobin drop 12 to 24 hours post partum difference between pre and post partum hemoglobin levels
drop in hemoglobin 12 to 24 hours post partum 2g/dl drop in hemoglobin
mean estimated blood loss during the first hour post partum visual estimation of blood loss
side effect of medication upto 48 hours after delivery fever \> 38°C, diarrhea, and shivering
Trial Locations
- Locations (1)
Makassed General Hospital
🇱🇧Beirut, Lebanon