Condition category
Pregnancy and Childbirth
Date applied
22/03/2010
Date assigned
07/04/2010
Last edited
07/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes