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
Yves.jacquemyn@uza.be

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yves Jacquemyn

ORCID ID

Contact details

Wilrijkstraat 10
Edegem
2650
Belgium
yves.jacquemyn@uza.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OBGYN-1

Study information

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

Study hypothesis

Single shot intraveneous carbetocin is accompanied with more nausea and vomitus as compared to intravenous oxytocin.

Ethics approval

Ethics Committee Ethisch Comité Universitair Zieknhusi Antwerpen, 21/02/2011, ref: B300201110299

Study design

Prospective randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pregnancy and delivery

Intervention

Standard intravenous carbetocin vs standard intravenous oxytocin

Intervention type

Other

Phase

Not Applicable

Drug names

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

15/02/2013

Overall trial end date

15/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Term uncomplicated pregnant women who undergo a planned cesarean section.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Unplanned caesarean section
2. Complications including: hypertension, preterm labour, any gatsrointestinal or cardiovascular disease necessitating treatment

Recruitment start date

15/02/2013

Recruitment end date

15/02/2014

Locations

Countries of recruitment

Belgium

Trial participating centre

Wilrijkstraat 10
Edegem
2650
Belgium

Sponsor information

Organisation

Antwerp University Hospital (Belgium)

Sponsor details

Department of Obstetrics
Wilrijkstraat 10
Edegem
2650
Belgium
yves.jacquemyn@uza.be

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Obstetrics, Antwerp University Hospital (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Editorial Notes