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

This study has been terminated.
(reason of halt prematurely: futility of the trial)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01113229
First received: April 28, 2010
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hemorrhage; Complicating Delivery
Drug: Misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Occurrence of post partum hemorrhage > 500mL in 1 hour [ Time Frame: 1 HOUR ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of post partum hemorrhage > 1000mL in 1 hour [ Time Frame: 1 HOUR ] [ Designated as safety issue: Yes ]

Enrollment: 1721
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: two misoprostol tablets taken orally (400µg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113229

Locations
France
Chi Poissy St Germain
Poissy, France, 78300
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Patrick Rozenberg, MD CHI POISSY ST GERMAIN
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01113229     History of Changes
Other Study ID Numbers: P 081104, 2009-013177-18
Study First Received: April 28, 2010
Last Updated: August 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Post Partum Haemorrhage,
oxytocin,
misoprostol,
prevention,
delivery.

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 16, 2014