A comparison of carbetocin and oxytocin in prevention of uterine atony following emergency Caesarean section
| ISRCTN | ISRCTN18976822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18976822 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/03/2010
- Registration date
- 07/04/2010
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nuguelis Razali
Scientific
Scientific
Department of Obstetrics and Gynaecology, University Malaya Medical Center, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| nuguelis@um.edu.my |
Study information
| Study design | Randomised double blind prospective single centre study |
|---|---|
| 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 | A double blind randomized comparison of carbetocin and oxytocin in prevention of uterine atony following emergency Caesarean section |
| Study objectives | A single injection of carbetocin is as effective as oxytocin in preventing excessive intraoperative blood loss after caesarean section and less likely to need additional oxytocin for uterine atony or excessive bleeding. |
| Ethics approval(s) | University Malaya Medical Centre Ethics Committee Board, Reference no : 678.18. Date of approval 17 September 2008 |
| Health condition(s) or problem(s) studied | Post delivery via emergency caesarean section |
| Intervention | This is a randomised double blind study comparing Oxytocin and Carbetocin. For each of the study subjects, the kits containing each study drugs (which are identical) will be prepared according to the randomisation made so as to secure the blinding of the clinician as well as the patient. After the foetus and placenta has been delivered, 1 ml of the study drug as prepared in each kit will be administered intravenously through the subject's intravenous line with the help of the anaesthetic staff in charge. |
| Intervention type | Other |
| Primary outcome measure | Need for additional uterotonic intervention within 24 hours after LSCS to maintain the adequacy of uterine tone as judged by the attending surgeon and clinician. |
| Secondary outcome measures | 1. Drop in haemoglobin and haematocrit level by 24 hours postoperatively 2. Total estimated blood loss 3. Vital signs 4. Side effects 5. Operating time 6. Need for blood transfusion |
| Overall study start date | 15/12/2008 |
| Completion date | 15/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 600 |
| Total final enrolment | 547 |
| Key inclusion criteria | Women of 18 years or older with a term (more than 37 weeks period of gestation), singleton pregnancy who will be undergoing an emergency Lower Segment Caesarean Section (LSCS) under regional anaesthesia. An emergency LSCS has been defined as an unplanned LSCS which is performed once labour has commenced or during the process of labour for any reasons indicated. Labour in this context has been defined as documented regular contractions with frequency of at least once in 10 minutes with cervical dilatation of 3cm and more. |
| Key exclusion criteria | 1. Suspected or known coagulopathy 2. Hypersensitivity to the study drugs 3. History of heart disease including 3.1. Cardiac arrhythmia 3.2. Hypertension 3.3. Evidence of liver, renal or endocrine diseases (other than gestational diabetes) 4. LSCS is done under general anaesthesia for any reason 5. Diagnosed placenta praevia 6. Placental abruption 7. Fibroid in pregnancy |
| Date of first enrolment | 15/12/2008 |
| Date of final enrolment | 15/12/2010 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Department of Obstetrics and Gynaecology, University Malaya Medical Center, Lembah Pantai
Kuala Lumpur
59100
Malaysia
59100
Malaysia
Sponsor information
University Malaya Medical Centre (Malaysia)
University/education
University/education
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
43000
Malaysia
| nuguelis@um.edu.my | |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
The University of Malaya (Malaysia) - research grant (ref: UMRG 108/09 HTM)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
