Comparison of Carbetocin vs Oxytocin for prevention of haemorrhage after delivery in women undergoing Caesarean section

Phase 3

Not yet recruiting

Conditions: Other immediate postpartum hemorrhage,

Registration Number: CTRI/2022/06/043237

Lead Sponsor: IQ City Medical College Hospital

Brief Summary: Postpartum haemorrhage (PPH) continues to be the leading cause of maternal mortality in middle and low-income countries including India. Much advancement has been made in the field of treatment of PPH, but not much progress has been made in the field of prevention, where one of its main component is administration of uterotonic, preferably oxytocin, immediately after birth of the baby. In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding other uterotonics: Ergometrine degrades when exposed to heat or light and Misoprostol degrades rapidly when exposed to moisture. Innovation in the manufacture of carbetocin has met the stability requirements in hot and humid climates. Both Carbetocin and Oxytocin are approved drugs for active managemrent of third stage of labour (AMTSL) and prevention of PPH. This study has been undertaken to evaluate the uterotonic effect of carbetocin compared to oxytocin for the prevention of primary PPH in emergency or elective Caesarean delivery. The purpose of this study is to determine if carbetocin is superior to oxytocin in terms of reduction in the need of additional uterotonic agents and the occurrence of PPH.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 340

Inclusion Criteria

1.Age 21 to 45 years 2.Emergency or elective Caesarean section 3.Singleton pregnancy.

Exclusion Criteria

1.Contraindication for carbetocin and oxytocin known allergy or hypersensitivity to carbetocin or oxytocin 2.Cases of coagulopathy 3.Multifoetal gestation 4.Medical diseases as cardiac, hypertension, liver, renal or endocrine diseases 5.Uterine fibroids 6.Suspected placental pathology (placenta accreta, praevia or abruption) 7.General anaesthesia 8.Classical uterine incision 9.Those who did not give consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of blood loss	First 24 hours post-operative
Use of additional uterotonics	First 24 hours post-operative

Secondary Outcome Measures

Name	Time	Method
change in blood pressure	after one hour of drug administration
change in pulse rate	after one hour of drug administration
change in haemoglobin	24 hours after lscs
need of blood transfusion	during first 24 hours post operative

Trial Locations

Locations (1): IQ City Medical College Hospital
🇮🇳
Barddhaman, WEST BENGAL, India
IQ City Medical College Hospital
🇮🇳Barddhaman, WEST BENGAL, India
Dr ISHA SUDRANIA
Principal investigator
7502707024
isha107@gmail.com