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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 April 2015 |
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Main ID: |
NCT01113229 |
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Date of registration:
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28/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
CYTOCINON |
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Scientific title:
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Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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1721 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01113229 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Patrick Rozenberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHI POISSY ST GERMAIN |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hemorrhage; Complicating Delivery
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Intervention(s)
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Drug: Misoprostol
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Primary Outcome(s)
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Occurrence of post partum hemorrhage > 500mL in 1 hour
[Time Frame: 1 HOUR]
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Secondary Outcome(s)
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Occurrence of post partum hemorrhage > 1000mL in 1 hour
[Time Frame: 1 HOUR]
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Secondary ID(s)
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2009-013177-18
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P 081104
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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