Carbetocin RTS A65870
Research type
Research Study
Full title
A Phase III, randomized, double blind, active, controlled, multinational, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally
IRAS ID
160165
Contact name
Mariana Widmer
Contact email
Sponsor organisation
World Health Organisation
Eudract number
2014-004445-26
Clinicaltrials.gov Identifier
ANZCTR366743, Additional WHO Reference Number; ACTRN12614000870651, Australian New Zealand Clinical Trial Registry
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Postpartum haemorrhage (PPH) (bleeding after birth) is the leading cause of maternal mortality in low-income countries and it contributes to nearly a quarter of maternal deaths globally. The majority of deaths due to PPH could be avoided through the use of certain drugs (uterotonics) during the third stage of labour.
Oxytocin is currently the recommended uterotonic drug of choice, but this needs to be refrigerated. The manufacturer of carbetocin, another uterotonic, (Ferring Pharmaceuticals) has recently developed a room temperature stable formulation (carbetocin RTS) which makes it an attractive option for countries where refrigeration of drugs can be problematic.
Merck for Mothers, Ferring Pharmaceuticals and the World Health Organization would like to evaluate carbetocin RTS as a promising intervention for reducing PPH, particularly in settings where cold storage is difficult to achieve and maintain.
This will be a hospital-based, multicentre, double-blind, randomised, non-inferiority, active controlled trial.
Each woman will be randomised to receive either oxytocin 10 IU IM or carbetocin RTS 100 µg IM after the vaginal birth of her baby, and blood loss will be measured for one hour or up to two hours postpartum if the bleeding continues beyond one hour, by placing a calibrated drape (a sheet that measures amount of blood lost) under the woman.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0071
Date of REC Opinion
27 Mar 2015
REC opinion
Further Information Favourable Opinion