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

Study Overview
=================
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.

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

Conditions
-----------------
Hemorrhage; Complicating Delivery

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp | Drug: Misoprostol<br>* two misoprostol tablets taken orally (400µg)<br>* Other names: two misoprostol tablets taken orally (400µg;|
| Placebo Comparator: PLACEBO<br>10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp. | Drug: Misoprostol<br>* two misoprostol tablets taken orally (400µg)<br>* Other names: two misoprostol tablets taken orally (400µg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of post partum hemorrhage > 500mL in 1 hour |  | 1 HOUR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of post partum hemorrhage > 1000mL in 1 hour |  | 1 HOUR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post Partum Haemorrhage,, oxytocin,, misoprostol,, prevention,, delivery.