Carbetocin versus oxytocin for the prevention of post-partum hemorrhage in caesarean section
| ISRCTN | ISRCTN69805695 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69805695 |
| Secondary identifying numbers | SSMCH201476 |
- Submission date
- 10/03/2016
- Registration date
- 20/04/2016
- Last edited
- 13/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Popular Diagnostic centre
Shyamoli
Dhaka
-
Bangladesh
 ORCID ID |
0000-0002-4087-1818 |
|---|
Scientific
Department of Obstetrics and Gynecology
Sir Salimullah Medical College and Mitford Hospital
Dhaka
-
Bangladesh
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Carbetocin versus oxytocin for the prevention of post-partum hemorrhage in caesarean section: a randomised controlled trial |
| Study objectives | Carbetocin is more effective than oxytocin in the active management of third stage of labour. |
| Ethics approval(s) | Institutional Ethics Committee of Sir Salimullah Medical College, Dhaka, Bangladesh, 22/12/2014, Ref no- SSMC /2014/76 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Carbetocin, oxytocin |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Completion date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 64 |
| Key inclusion criteria | Women with a single pregnancy undergoing cesarean delivery at term |
| Key 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 |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 01/12/2015 |
Locations
Countries of recruitment
- Bangladesh
Study participating centre
-
Bangladesh
Sponsor information
Industry
153-154 Tejgaon I/A
Dhaka-1208
Dhaka
-
Bangladesh
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Next issue of FIGO journal |
| IPD sharing plan |
