Delivery Clinical Trial
Official title:
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
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.
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 from the genital tract within 24 hours of the birth of a baby. PPH can be
minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine
atony, contributing up to 80 % of the PPH cases.
Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body
mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.
Oxytocin is currently the uterotonic of first choice. It has proven to decrease the
incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A
disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a
continuous intravenous infusion or repeated intramuscular injections.
Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony
after child birth by CS under epidural or spinal anaesthesia. Carbetocin has a rapid onset
of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of
sustained uterine response with contractions of higher amplitude and frequency. Its safety
profile is comparable to that of oxytocin.
The study will be conducted in Cairo university hospitals and BeniSuef university hospitals.
All patients with at least 2 risk factors for developing atonic PPH will be approached in
the antenatal clinic or early in labour if appropriate. Risk factors include previous PPH,
BMI>35, multiple pregnancy, prolonged labour >12 hours, fetal macrosomia>4kg and induction
of labour. Women will be invited to participate in the study, the invitation will include a
clear full explanation of the study. Only patients signing informed written consents will
participate in the study.
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. We will not include a control group for ethical reasons.
The uterine tone and amount of bleeding will be noted and the need for further uterotonic
agents will be determined 2 minutes after giving the drug. Blood loss will be estimated
through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24
hours after delivery.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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