A study on side effects such as nausea and vomitus after medication to prevent excessive bleeding after a caesarean section

ISRCTN ISRCTN95504420
DOI https://doi.org/10.1186/ISRCTN95504420
Secondary identifying numbers OBGYN-1
Submission date
03/02/2013
Registration date
28/02/2013
Last edited
07/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 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

Contact information

Prof Yves Jacquemyn
Scientific

Wilrijkstraat 10
Edegem
2650
Belgium

Email yves.jacquemyn@uza.be

Study information

Study designProspective randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleOBGYN-1: A randomized controlled trial on nausea, vomitus and blood pressure changes comparing carbetocine versus oxytocine in the prevention of hemorrhage after caesarean section
Study acronymNAVOCASY
Study objectivesSingle shot intraveneous carbetocin is accompanied with more nausea and vomitus as compared to intravenous oxytocin.
Ethics approval(s)Ethics Committee Ethisch Comité Universitair Zieknhusi Antwerpen, 21/02/2011, ref: B300201110299
Health condition(s) or problem(s) studiedPregnancy and delivery
InterventionStandard intravenous carbetocin vs standard intravenous oxytocin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Carbetocin, oxytocin
Primary outcome measureFrom 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 measuresAny other complaint
Overall study start date15/02/2013
Completion date15/02/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants60
Key inclusion criteriaTerm uncomplicated pregnant women who undergo a planned cesarean section
Key exclusion criteria1. Unplanned caesarean section
2. Complications including: hypertension, preterm labour, any gastrointestinal or cardiovascular disease necessitating treatment
Date of first enrolment15/02/2013
Date of final enrolment15/02/2014

Locations

Countries of recruitment

  • Belgium

Study participating centre

Antwerp University Hospital
Edegem
2650
Belgium

Sponsor information

Antwerp University Hospital (Belgium)
Hospital/treatment centre

Department of Obstetrics
Wilrijkstraat 10
Edegem
2650
Belgium

Email yves.jacquemyn@uza.be
ROR logo "ROR" https://ror.org/01hwamj44

Funders

Funder type

Hospital/treatment centre

Department of Obstetrics, Antwerp University Hospital (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 02/01/2018 Yes No

Editorial Notes

07/03/2018: Publication reference added.