To compare Carbetocin with Oxytocin in Caesarean section for prevention of Post-partum haemorrhage(PPH) at a tertiary Institute: A randomised controlled study

Not yet recruiting

• Conditions: All term pregnant women undergoing Caesarean section in Regional Institute of Medical Sciences Imphal in Department of Obstetrics nd Gynaecology.

• Registration Number: CTRI/2022/04/041583
• Lead Sponsor: RIMS Imphal Golden Jubilee research Initiative

Brief Summary

Obstetric haemorrhage, especially postpartum haemorrhage (PPH) is responsible for more than a quarter of all maternal deaths worldwide. In most low-income countries, PPH is the leading cause of maternal deaths. Postpartum haemorrhage occurs in 5-15% of deliveries. The majority of PPH related morbidity and mortality are preventable through effective implementation of  evidenced-based guidelines. Uterine atony is responsible for more than 50% of occurrences of PPH, numerous strategies have been promoted to preserve uterine tone.There are several uterotonic drugs for preventing PPH but it is still debatable which drug is best. Oxytocin (10 IU) is administered for the prevention of PPH in low risk vaginal and caesarean deliveries. Carbetocin is a long-acting synthetic oxytocin analogue, 1-deamino-1- monocarbo-(2-O-Methyltyrosine)-oxytocin, firstly described in 1987. Carbetocin, given as 100 microgram as an IV bolus over 1 minute, instead of continuous infusion of oxytocin with a a similar safety profile and minor antidiuretic effect, in the third stage of labour and in the first 24 hours. Crabetocin is approved by WHO (2018) and included in the WHO (2019) essential medicines drug list. Storage and cold chain maintenance of Oxytocin is difficult unlike heat stable carbetocin in Manipur. Recently it has been approved by drug controller of India for use in prevention of  PPH and is now available in India. In Manipur, carbetocin has not been used and no such study in pregnant women for PPH prevention.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-31
• Study Start: 2022-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 346

Inclusion Criteria

Term Pregnant women reporting to the department of Obstetrics & Gynaecology who will be undergoing caesarean section and giving informed consent in the Regional Institute of Medical Sciences, a tertiary care centre of Imphal, Manipur.

Exclusion Criteria

Presence of Hypertension, antepartum haemorrhage, fibroid uterus or history of myomectomy, cardiac, renal or liver diseases, epilepsy, bleeding disorders, general anaesthesia and history of hypersensitivity to any drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the amount of blood loss as well as the uterine tone following carbetocin and oxytocin in caesareansection	Blood loss, Uterine tone and Vitals are monitored immediately, 2 hours and 24 hours after delivery

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of the drugs in terms of additional interventions needed and drop in haemoglobin	On admission and 24 hours after delivery

Trial Locations

Locations (1)

Regional Institute of Medical Sciences hospital; 🇮🇳 West, MANIPUR, India

Regional Institute of Medical Sciences hospital

🇮🇳West, MANIPUR, India

Pratima Khumanthem

Principal investigator

9612001318

pratimadutta09@gmail.com