Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

A double-blinded randomised control trial conducted in the Department of Obstetrics and Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for two years duration from January 1st, 2012 till December 31st, 2013.

The aim of the study is to compare the haemodynamic and cardiovascular effects between intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective Lower Segment Caesarean Section (EL LSCS).

Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly safe and has similar efficacy in comparison to a single injection of oxytocin.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Treatments: Carbetocin; Oxytocin

Criteria

Inclusion Criteria:

1. Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS.

2. Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH, obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby.

3. Ability to provide informed consent.

Exclusion Criteria:

1. Emergency caesarean section

2. Preterm Labour

3. Grandmultipara

4. Multiple Pregnancy

5. Placenta Previa

6. Previous PPH

7. Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2))

8. Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac diseases, history or evidence of liver, renal, vascular, or endocrine disease and bleeding disorder.

9. Contraindication to carbetocin and oxytocin

10. Language Barrier

11. Women undergoing general anaesthesia

12. Women who has abnormal baseline ECG that suggestive myocardial ischemia