الفهرس 
Acknowledgement
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Abstract
Postpartum haemorrhage (PPH) is defined as a blood loss of 500 mL or more within 24 hours of delivery, while severe PPH (sPPH) is defined as a blood loss of 1000 mL or more within the same time frame (WHO 2012).
Aim of the study:
The trial has two primary objectives:
(1) To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.
(2) To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.
Patients and methods:
This was a hospital based, multicenter, double-blind, randomized, non-inferiority, active controlled trial. Each woman had been randomized within centers to receive either oxytocin 10 IU IM or carbetocin RTS 100 ug IM. A non-inferiority design was chosen because the aim of the trial is to determine if carbetocin RTS, an alternative intervention with thermostability advantages is similar in efficacy to the standard intervention (oxytocin 10 IU IM).
Results:
In the present study, our center (Women’s Health Center) was a part of large multicenter randomized controlled study included ten different countries with our center as the only one in Egypt. Out of 29,645 women recruited globally, 3200 women were from Assiut center (11 %), 1600 in each arm who were randomized blindly to receive either carbetocin or oxytocin intramuscularly after delivery of the baby.
The first case was recruited in 20th November 2015 and the last one in 8th January 2017.
Regarding the primary outcome in our center, there is no difference regarding blood loss ≥500 ml or the need for the use of additional uterotonic agents. However, incidence of sPPH is 0% in both groups in our center in comparison to 1.5% in all centers.
Non-inferiority was demonstrated within the margin of non-inferiority on the relative scale, as the two-sided 95% CI fell entirely to the left of the margin 1.16 for the endpoint blood loss 500 mL or more or additional uterotonic use up to 2 hours. It just failed to be demonstrated for the endpoint blood loss 1000 mL or more, as the upper limit of the 95% is just above the non-inferiority margin of 1.23.
Conclusion:
Carbetocin RTS is not inferior to oxytocin in reduction of postpartum hemorrhage (blood loss more than 500ml) and or use of additional uterotonics after vaginal delivery. However, non-inferiority had not been proven regarding the incidence of severe PPH.
Conflict of interest:
The trial was supported by MSD, through the MSD for Mothers Program, an initiative of Merck; MSD had no commercial interest in the investiga- tional drug. Heat-stable carbetocin was provided by Ferring Pharmaceuticals and oxytocin by Novartis free of charge.
All investigators submitted declaration of disclosure to steering committee.