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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2014

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.

Interventions

  • Drug: Misoprostol
    • two misoprostol tablets taken orally (400µg)

Arms, Groups and Cohorts

  • Experimental: 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
  • Placebo Comparator: PLACEBO
    • 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of post partum hemorrhage > 500mL in 1 hour
    • Time Frame: 1 HOUR

Secondary Measures

  • Occurrence of post partum hemorrhage > 1000mL in 1 hour
    • Time Frame: 1 HOUR

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrick Rozenberg, MD, Principal Investigator, CHI POISSY ST GERMAIN

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