Contact information
Type
Scientific
Primary contact
Dr Nuguelis Razali
ORCID ID
Contact details
Department of Obstetrics and Gynaecology
University Malaya Medical Center
Lembah Pantai
Kuala Lumpur
59100
Malaysia
nuguelis@um.edu.my
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A double blind randomized comparison of Carbetocin and Oxytocin in prevention of uterine atony following emergency caesarean section.
Acronym
Study hypothesis
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
University Malaya Medical Centre Ethics Committee Board, Reference no : 678.18. Date of approval 17 September 2008
Study design
Randomised double blind prospective single centre study
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
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
Phase
Not Specified
Drug names
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 trial start date
15/12/2008
Overall trial end date
15/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant 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
Recruitment start date
15/12/2008
Recruitment end date
15/12/2010
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics and Gynaecology, University Malaya Medical Center, Lembah Pantai
Kuala Lumpur
59100
Malaysia
Sponsor information
Organisation
University Malaya Medical Centre (Malaysia)
Sponsor details
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
43000
Malaysia
nuguelis@um.edu.my
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The University of Malaya (Malaysia) - research grant (ref: UMRG 108/09 HTM)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list