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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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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN69805695 |
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Date of registration:
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20/04/2016 |
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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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Carbetocin versus oxytocin for the prevention of post-partum hemorrhage in caesarean section
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Scientific title:
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Carbetocin versus oxytocin for the prevention of post-partum hemorrhage in caesarean section: a randomised controlled trial |
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Date of first enrolment:
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01/01/2015 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN69805695 |
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Study type:
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Interventional |
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Study design:
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Single-centre randomised controlled trial (Treatment)
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Phase:
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Phase IV
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ferdousi
Begum |
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Address:
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Popular Diagnostic centre
Shyamoli
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Dhaka
Bangladesh |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Women with a single pregnancy undergoing cesarean delivery at term
Exclusion criteria: 1. Placenta praevia
2. Multiple gestations
3. Placental abruption
4. Hypertensive disorders in pregnancy
5. Preeclampsia
6. Cardiac, renal or liver diseases
7. Epilepsy
8. Women with history of hypersensitivity to carbetocin according to the Br National Formulary
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Third stage of labour
Pregnancy and Childbirth
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Intervention(s)
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64 pregnant women who had undergone cesarean delivery were randomized into two groups. One group of patients received intravenous 100 microgram carbetocin and another group of patients received intramuscular 10 IU oxytocin in the third stage of labour.
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Primary Outcome(s)
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Efficacy of carbetocin over oxytocin for the management of third stage of labor
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Secondary Outcome(s)
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1. The need for additional uterotonic within 24 hours of delivery after carbetocin or oxytocin administration
2. The amount of blood loss in 24 hours after delivery after carbetocin or oxytocin administration
3. The need for blood transfusion during the first 24 hours after delivery after carbetocin or oxytocin administration
4. The adverse effects of carbetocin and oxytocin after administration
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Secondary ID(s)
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SSMCH201476
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Source(s) of Monetary Support
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Investigator initiated and funded
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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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