CompletedPhase 3

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

Egypt200 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range20 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Need for other uterotonics

Timeframe: 2 minutes after giving the drug

Trial details

NCT IDNCT02304042

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

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