Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

National University of Malaysia (UKM)

Status: Completed

Conditions: Anaesthesia; Pregnancy Related

Treatments: Drug: Carbetocin; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01719952

UKMMC

Details and patient eligibility

About

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.

Full description

OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate (HR), saturation of oxygen (SpO2) in certain time after drug injection.

The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such as ST depression and changes in T-waves.

Hemoglobin and troponin-T level

The need for additional oxytocin infusion and estimated blood loss

The time interval between initial drug administration, type of additional oxytocic intervention that used and complication that happened.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups

Carbetocin

Experimental group

Description:

Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal

Treatment:

Drug: Carbetocin

Oxytocin

Active Comparator group

Description:

Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.

Treatment:

Drug: Oxytocin