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

April 7, 2015 updated by: Assistance Publique - Hôpitaux de Paris
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1721

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poissy, France, 78300
        • Chi Poissy St Germain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Misoprostol
two misoprostol tablets taken orally (400µg)
Other Names:
  • two misoprostol tablets taken orally (400µg
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.
Drug: Misoprostol
two misoprostol tablets taken orally (400µg)
Other Names:
  • two misoprostol tablets taken orally (400µg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Patrick Rozenberg, MD, Chi Poissy St Germain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (Estimate)

April 29, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 081104
  • 2009-013177-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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