Plain English Summary
Background and study aims
At the end of a cesarean section in Belgium, in general some medication is given to the mother to prevent excessive bleeding. The two products used most frequently are called carbetocin and oxytocin and work well. No difference has been demonstrated as far as the effect on prevention of bleeding is concerned. A major side effect of this kind of medication is nausea and vomitus and a lowering of blood pressure resulting in dizziness. The aim of the present study is to compare nausea, vomiting and changes in blood pressure between carbetocin and oxytocin.
Who can participate?
Any pregnant woman for whom a caesarean section is planned in a term ( full grown) pregnancy without any other complication can participate.
What does the study involve?
Participants are randomly allocated to one of two groups:
All women will receive an intravenous medication to prevent bleeding and no one (participant, operating or treating team) will not know whether the medication used is carbetocin or oxytocin.
What are the possible benefits and risks of participating?
There is no difference with routine management during which both medications are used. The results of this study will help future patients to receive the product with the fewest side effects.
Where is the study run from?
The study will be run in the Obstetrics Ward at Antwerp University Hospital UZA, Belgium.
When is the study starting and how long is it expected to run for?
The study will be running for one year and will start in March 2013.
Who is funding the study?
This study is not funded by any pharmaceutical company, all costs are taken care of by the local Fund for perinatal Medicine of the Department of Obstetrics at Antwerp University Hospital
Who is the main contact?
Prof Dr Yves Jacquemyn
Prof Yves Jacquemyn
OBGYN-1: A randomized controlled trial on nausea, vomitus and blood pressure changes comparing carbetocine versus oxytocine in the prevention of hemorrhage after caesarean section
Single shot intraveneous carbetocin is accompanied with more nausea and vomitus as compared to intravenous oxytocin.
Ethics Committee Ethisch Comité Universitair Zieknhusi Antwerpen, 21/02/2011, ref: B300201110299
Prospective randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Pregnancy and delivery
Standard intravenous carbetocin vs standard intravenous oxytocin
Primary outcome measures
From the moment the participant enters the operating theatre until one hour later, blood pressure and heart frequence are carefully registered every 5 minutes or more as during routine monitoring of surgery. Nausea and vomitus are evaluated before surgery (just before incision), during surgery: before giving the intravenous medication and after 5, 10 and 15 minutes based on the standardized scale:
0: no nausea, no vomitus
1: mild nausea, no vomiting
2: nausea but with retching, no vomiting
3: nausea and vomiting
Secondary outcome measures
Any other complaint
Overall trial start date
Overall trial end date
Participant inclusion criteria
Term uncomplicated pregnant women who undergo a planned cesarean section.
Target number of participants
Participant exclusion criteria
1. Unplanned caesarean section
2. Complications including: hypertension, preterm labour, any gatsrointestinal or cardiovascular disease necessitating treatment
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Antwerp University Hospital (Belgium)
Department of Obstetrics
Department of Obstetrics, Antwerp University Hospital (Belgium)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting