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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

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 (Syntocinon®, Novartis, Switzerland). Both drugs will be diluted in 10ml saline and will be given by the slowly intravenously after delivery of the anterior shoulder. The investigators will not include a control group for ethical reasons.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Carbetocin; Oxytocin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Gestational age <37 weeks

• Placenta previa

• Hypertension.

• Preeclampsia.

• Cardiac, renal or liver diseases

• Known hypersensitivity to Carbetocin.