Status:
COMPLETED
Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Delivered Vaginally With at Least 2 Risk Factors for Atonic PPH: A Randomised Controlled Trial
Lead Sponsor:
Cairo University
Conditions:
Delivery
Eligibility:
FEMALE
20-40 years
Phase:
PHASE3
Brief Summary
250 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Synt...
Detailed Description
Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries (1). Postpartum haemorrhage (PPH) is defined as a blood loss \>500 ml more of blood f...
Eligibility Criteria
Inclusion
- Women with at least 2 risk factors for developing PPH. Risk factors include previous PPH, BMI\>35, multiple pregnancy, prolonged labour \>12 hours, ultrasound estimated fetal weight\>4kg and induction of labour.
Exclusion
- Gestational age \<37 weeks
- Placenta previa
- Hypertension.
- Preeclampsia.
- Cardiac, renal or liver diseases
- Known hypersensitivity to Carbetocin.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02304042
Start Date
November 1 2014
End Date
July 1 2015
Last Update
July 2 2015
Active Locations (2)
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1
BeniSuef University hospitals
BeniSuef, Egypt
2
Cairo University Hospitals
Cairo, Egypt