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A study on side effects such as nausea and vomitus after medication to prevent excessive bleeding after a caesarean section
ISRCTN ISRCTN95504420
DOI 10.1186/ISRCTN95504420
ClinicalTrials.gov identifier
EudraCT number
Public title A study on side effects such as nausea and vomitus after medication to prevent excessive bleeding after a caesarean section
Scientific title 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
Acronym NAVOCASY
Serial number at source OBGYN-1
Study hypothesis Single shot intraveneous carbetocin is accompanied with more nausea and vomitus as compared to intravenous oxytocin.
Lay 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
Yves.jacquemyn@uza.be
Ethics approval Ethics Committee Ethisch Comité Universitair Zieknhusi Antwerpen, 21/02/2011, ref: B300201110299
Study design Prospective randomized controlled trial
Countries of recruitment Belgium
Disease/condition/study domain Pregnancy and delivery
Participants - inclusion criteria Term uncomplicated pregnant women who undergo a planned cesarean section.
Participants - exclusion criteria 1. Unplanned caesarean section
2. Complications including: hypertension, preterm labour, any gatsrointestinal or cardiovascular disease necessitating treatment
Anticipated start date 15/02/2013
Anticipated end date 15/02/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions Standard intravenous carbetocin vs standard intravenous oxytocin
Primary outcome measure(s) 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 measure(s) Any other complaint
Sources of funding Department of Obstetrics, Antwerp University Hospital (Belgium)
Trial website
Publications
Contact name Prof  Yves  Jacquemyn
  Address Wilrijkstraat 10
  City/town Edegem
  Zip/Postcode 2650
  Country Belgium
  Email yves.jacquemyn@uza.be
Sponsor Antwerp University Hospital (Belgium)
  Address Department of Obstetrics
Wilrijkstraat 10
  City/town Edegem
  Zip/Postcode 2650
  Country Belgium
  Email yves.jacquemyn@uza.be
Date applied 03/02/2013
Last edited 01/11/2013
Date ISRCTN assigned 28/02/2013
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