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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01113229
First received: April 28, 2010
Last updated: October 12, 2012
Last verified: February 2011
History of Changes
  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:

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

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 ]

Estimated Enrollment: 3100
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113229

Locations
France
Chi Poissy St Germain Recruiting
Poissy, France, 78300
Contact: Patrick Rozenberg, PH     +33(0)1 39 27 52 57 ext +33     prozenberg@chi-poissy-st-germain.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Patrick Rozenberg, PH 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: October 12, 2012
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
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 19, 2013