Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin

Not Applicable

Completed

• Conditions: Anaesthesia; Pregnancy Related
• Interventions: Drug: Carbetocin; Drug: Oxytocin

• Registration Number: NCT01719952
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbetocin	Carbetocin	Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal
Oxytocin	Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Haemodynamic effects	2 years	1. Haemodynamic effect (blood pressure, heart rate, saturation of oxygen); 2. Presence of ECG changes such as ST depression and changes in T-waves; 3. Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain); 4. To compare the troponin T levels

Secondary Outcome Measures

Name	Time	Method
Blood loss measurement	2 years	1. Need for additional oxytocin infusion; 2. Total blood loss; 3. Drop in haemoglobin level post-operatively

Trial Locations

Locations (1)

Department of O&G; 🇲🇾 Cheras, Kuala Lumpur, Malaysia