Clinical trial NCT02983591: Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin
Official title: Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Post Partum Hemorrhage After Labor Induction
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* women with single viable pregnancy,
* cephalic presentation,
* at full term
* whom labor was induced by Oxytocin were eligible

Exclusion Criteria:

* delivery by cesarean section
* received other prophylactic uterotonics

Primary outcomes:
measure: Hemoglobin level
timeFrame: 12 to 24 hours post partum
Secondary outcomes:
measure: mean hemoglobin drop
timeFrame: 12 to 24 hours post partum
measure: mean estimated blood loss
timeFrame: during the first hour post partum
measure: drop in hemoglobin
timeFrame: 12 to 24 hours post partum
measure: side effect of medication
timeFrame: upto 48 hours after delivery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
References: