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

Department of Obstetrics and Gynaecology, University Malaya Medical Center, Lembah Pantai
Kuala Lumpur
59100
Malaysia

Email nuguelis@um.edu.my

Study information

Study designRandomised double blind prospective single centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA double blind randomized comparison of carbetocin and oxytocin in prevention of uterine atony following emergency Caesarean section
Study objectivesA 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) studiedPost delivery via emergency caesarean section
InterventionThis 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 typeOther
Primary outcome measureNeed 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 measures1. 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 date15/12/2008
Completion date15/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants600
Total final enrolment547
Key inclusion criteriaWomen 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 criteria1. 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 enrolment15/12/2008
Date of final enrolment15/12/2010

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Department of Obstetrics and Gynaecology, University Malaya Medical Center, Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor information

University Malaya Medical Centre (Malaysia)
University/education

Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
43000
Malaysia

Email nuguelis@um.edu.my
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.