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A comparison of carbetocin and oxytocin in prevention of uterine atony following emergency Caesarean section

A double blind randomized comparison of carbetocin and oxytocin in prevention of uterine atony following emergency Caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18976822
Enrollment
600
Registered
2010-04-07
Start date
2008-12-15
Completion date
Unknown
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post delivery via emergency caesarean section Pregnancy and Childbirth Single delivery by caesarean section

Interventions

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

Sponsors

University Malaya Medical Centre (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026