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
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