NCT02983591

Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin

Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Makassed General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prevention of Post Partum Hemorrhage After Labor Induction

Interventions

Type	Name	Description
DRUG	Misoprostol after delivery	Patients will receive 1000 mcg Misoprostol per rectum
DRUG	Oxytocin after delivery	Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
DRUG	Oxytocin before delivery	All patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-12-30
• Completion: 2017-12-30
• First posted: 2016-12-06
• Last updated: 2018-01-16

Locations

1 site across 1 country: Lebanon