Condition category
Pregnancy and Childbirth
Date applied
16/01/2012
Date assigned
07/03/2012
Last edited
07/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Oxytocin (Syntocinon®) is the first-choice drug for the prevention of postpartum bleeding after Caesarean section (CS). A disadvantage of oxytocin is its short duration of action. Carbetocin (Pabal®) is the first long-acting analogue of oxytocin. Its safety is comparable with that of oxytocin. Carbetocin is indicated for the prevention of uterus atony after CS under local anaesthesia. The aim of this study is to compare the effectiveness of carbetocin with that of oxytocin by assessing the need for additional uterotonic medication after elective CS in five leading Dutch centres.

Who can participate?
Women undergoing elective CS under epidural and/or spinal anaesthesia and treated with carbetocin or oxytocin.

What does the study involve?
Information will be gathered of 50 patients per centre after a single injection of carbetocin after elective CS prescribed by the gynaecologist. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during CS. No effort is expected from the study subjects. In addition, charts of patients treated with oxytocin for the prevention of postpartum bleeding after elective CS, will be retrieved.

What are the possible benefits and risks of participating?
Possible benefits for the study subjects could be the long-acting contraction of the uterus owing to carbetocin resulting in less blood loss. There are no possible risks of participating, since carbetocin and oxytocin are given on prescription to women eligible to receive it. No extra study procedures are needed.

Where is the study run from?
The study is initiated by the University Hospital Utrecht, the Netherlands.

When is the study starting and how long is it expected to run for?
The study ran from July 2009 until December 2011.

Who is funding the study?
Ferring B.V., the Netherlands.

Who is the main contact?
Prof. dr. H.W. Bruinse, University Hospital Utrecht, The Netherlands

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hein Bruinse

ORCID ID

Contact details

University Medical Center Utrecht (WKZ)
Lundlaan 6
Utrecht
3584 EA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Study on the use of carbetocin (Pabal®) in comparison with oxytocin (Syntocinon®) for the prevention of postpartum haemorrhage (the need for additional uterotonic medication) after elective caesarean section

Acronym

Study hypothesis

To compare retrospectively the efficacy of carbetocin with oxytocin by assessing the need for additional uterotonic interventions after elective Caesarean Section (CS) in five leading Dutch centres.

Ethics approval

According to the Dutch law (The Medical Research Involving Human Subjects Act) the study does not need to be seen by an ethics committee. The medication was given only within the label in women eligible to receive it. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during CS. No effort is expected from the study subjects.

Study design

Open-label multi-centre observational study

Primary study design

Observational

Secondary study design

Multi-centre

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

Obstetrics / Caesarean section

Intervention

After treatment on prescription with carbetocin or oxytocin, information will be gathered from the patient's chart. The follow-up time is 24 hours after medication administration.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Need for additional uterotonic treatment during the first 24 hours after carbetocin or oxytocin administration.

Secondary outcome measures

1. Need for blood transfusion during the first 24 hours
2. Need for operative interventions other than the initial CS during the first 24 hours
3. Need for uterus massage during the first 24 hours
4. Change in haematocrit and haemoglobin post versus pre CS
5. Amount of intraoperative blood loss
6. Incidence of intraoperative blood loss > 500 ml
7. Incidence of intraoperative blood loss > 1000 ml
8. Position of fundus after wound closure (only in prospective part of the study)
9. Uterus tone after uterotonic treatment
10. Investigator’s subjective experience with oxytocin/carbetocin

Overall trial start date

01/07/2009

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Charts of women who have undergone elective CS under epidural and/or spinal anaesthesia and treated with carbetocin or oxytocin.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1500

Participant exclusion criteria

Contraindications, warnings, precautions and interactions with other drugs mentioned in the summary of product characteristics of carbetocin and oxytocin.

Recruitment start date

01/07/2009

Recruitment end date

01/12/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (WKZ)
Utrecht
3584 EA
Netherlands

Sponsor information

Organisation

Ferring B.V. (Netherlands)

Sponsor details

Polarisavenue 130
Hoofddorp
2130 AD
Netherlands

Sponsor type

Industry

Website

http://www.ferring.nl

Funders

Funder type

Industry

Funder name

Ferring B.V. (Netherlands)

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

Additional files

Editorial Notes