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

Prevention of Post Partum Hemorrhage After Labor Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983591
• Other study ID #: 16082016
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: January 12, 2018
• Start date: November 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: January 2018
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Prevention of Post Partum Hemorrhage After Labor Induction

Intervention

Drug:
• Misoprostol after delivery
Patients will receive 1000 mcg Misoprostol per rectum
• Oxytocin after delivery
Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
• 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

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level	10% or more drop in hemoglobin	12 to 24 hours post partum
Secondary	mean hemoglobin drop	difference between pre and post partum hemoglobin levels	12 to 24 hours post partum
Secondary	mean estimated blood loss	visual estimation of blood loss	during the first hour post partum
Secondary	drop in hemoglobin	2g/dl drop in hemoglobin	12 to 24 hours post partum
Secondary	side effect of medication	fever > 38°C, diarrhea, and shivering	upto 48 hours after delivery