Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

Phase 4

Terminated

• Conditions: Hemorrhage; Complicating Delivery
• Interventions: Drug: Misoprostol

• Registration Number: NCT01113229
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

Detailed Description

Objective :

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.

Method :

Double blinded Randomized controlled trial in two centers over 30 months.

Treatment :

Patients will be randomly allocated into one of the two following group :

Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp.

Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.

Number of patients:

1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). Patients were included in the study during 48 hours.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1721

Inclusion Criteria

• Women>18 years,
• during first stage of normal labor,
• at 36 to 42 weeks,
• with epidural analgesia and informed signed consent

Exclusion Criteria

• Cesarean section delivery,
• clotting disorders,
• prostaglandin allergy,
• absent consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	Misoprostol	10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.
Misoprostol	Misoprostol	10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp

Primary Outcome Measures

Name	Time	Method
Occurrence of post partum hemorrhage > 500mL in 1 hour	1 HOUR

Secondary Outcome Measures

Name	Time	Method
Occurrence of post partum hemorrhage > 1000mL in 1 hour	1 HOUR

Trial Locations

Locations (1)

Chi Poissy St Germain; 🇫🇷 Poissy, France