Condition category
Pregnancy and Childbirth
Date applied
10/03/2016
Date assigned
20/04/2016
Last edited
13/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A caesarean section is an operation to deliver a baby. There is a risk of heavy bleeding after caesarean section, known as postpartum haemorrhage (PPH). The aim of this study is to evaluate the effectiveness and safety of the drug carbetocin in comparison to oxytocin at preventing PPH in the third stage of labour (when the placenta is delivered) after caesarean section.

Who can participate?
Women with a single pregnancy undergoing cesarean delivery at term

What does the study involve?
Participants are randomly allocated to be treated with either intravenous (into a vein) carbetocin or intramuscular (into a muscle) oxytocin in the third stage of labour. The amount of blood lost, the need for additional drugs and blood transfusions, and adverse effects are recorded in both groups.

What are the possible benefits and risks of participating?
The possible benefit is control of bleeding after cesarean section, which could otherwise lead to postpartum hemorrhage with fatal outcome. There is a small risk of minor side effects.

Where is the study run from?
Sir Salimullah Medical College and Mitford Hospital (Bangladesh)

When is the study starting and how long is it expected to run for?
January to December 2015

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Prof Ferdousi Begum
2. Dr Shakila Yesmin

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ferdousi Begum

ORCID ID

http://orcid.org/0000-0002-4087-1818

Contact details

Popular Diagnostic centre
Shyamoli
Dhaka
-
Bangladesh

Type

Scientific

Additional contact

Dr Shakila Yesmin

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Sir Salimullah Medical College and Mitford Hospital
Dhaka
-
Bangladesh

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SSMCH201476

Study information

Scientific title

Carbetocin versus oxytocin for the prevention of post-partum hemorrhage in caesarean section: a randomised controlled trial

Acronym

Study hypothesis

Carbetocin is more effective than oxytocin in the active management of third stage of labour.

Ethics approval

Institutional Ethics Committee of Sir Salimullah Medical College, Dhaka, Bangladesh, 22/12/2014, Ref no- SSMC /2014/76

Study design

Single-centre randomised 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

Third stage of labour

Intervention

64 pregnant women who had undergone cesarean delivery were randomized into two groups. One group of patients received intravenous 100 microgram carbetocin and another group of patients received intramuscular 10 IU oxytocin in the third stage of labour.

Intervention type

Drug

Phase

Phase IV

Drug names

Carbetocin, oxytocin

Primary outcome measures

Efficacy of carbetocin over oxytocin for the management of third stage of labor

Secondary outcome measures

1. The need for additional uterotonic within 24 hours of delivery after carbetocin or oxytocin administration
2. The amount of blood loss in 24 hours after delivery after carbetocin or oxytocin administration
3. The need for blood transfusion during the first 24 hours after delivery after carbetocin or oxytocin administration
4. The adverse effects of carbetocin and oxytocin after administration

Overall trial start date

01/01/2015

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Women with a single pregnancy undergoing cesarean delivery at term

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

64

Participant exclusion criteria

1. Placenta praevia
2. Multiple gestations
3. Placental abruption
4. Hypertensive disorders in pregnancy
5. Preeclampsia
6. Cardiac, renal or liver diseases
7. Epilepsy
8. Women with history of hypersensitivity to carbetocin according to the Br National Formulary

Recruitment start date

01/01/2015

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Sir Salimullah Medical College and Mitford Hospital
Dhaka
-
Bangladesh

Sponsor information

Organisation

Beacon Pharmaceuticals Ltd (Bangladesh)

Sponsor details

153-154 Tejgaon I/A
Dhaka-1208
Dhaka
-
Bangladesh

Sponsor type

Industry

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Next issue of FIGO journal

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes