A comparison of Oxytocin andCarbetocin for the prevention of postpartum haemorrhage in high risk patients undergoing cesarean delivery

Not yet recruiting

• Conditions: High risk pregnant female patients posted for elective cesarean delivery of ASA grade III and IV aged between 18 and 40 years with 35-40 weeks of gestation

• Registration Number: CTRI/2023/03/050426
• Lead Sponsor: PDU Govt Medical College Rajkot

Brief Summary

Post partum hemorrhage(PPH) is still a major cause of maternal morbidity and mortality. PPH is responsible for majority of maternal mortality in India and globally. There have been few studies/literature of effectiveness of  carbetocin for the prevention of PPH  following cesarean delivery, hence we decided to do a prospective study comparing prophylactic administration of oxytocin and carbetocin and to study its efficacy in prevention of PPH in high-risk females undergoing cesarean delivery.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-04
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

High risk pregnant patients posted for elective cesarean delivery under spinal anaesthesia of ASA Grade III and IV with 35-40 weeks of gestation, Multiple pregnancies, Previous cesarean scar, Presence of uterine fibroids, Previous myomectomy, Presence of placenta previa, Past history of PPH.

Exclusion Criteria

Hypertension, Preeclampsia, Cardiac diseases, Renal diseases, Liver diseases, Epilepsy, Neuromuscular diseases, Severe anemia, General Anaesthesia, Women with history of hypersensitivity to carbetocin/oxytocin, Patient refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Oxytocin and Carbetocin in terms of intraoperative blood loss, additional uterotonic needed and adverse effects if any in caesarean delivery with high risk of post-partum haemorrhage. To compare the hemodynamic effects of Oxytocin and Carbetocin (effects on heart rate and blood pressure)	Heart rate and blood pressure noted before skin incision, after 1 minute, 3 minutes, 5 minutes, at the time of skin closure, after 2 hours, after 12 hours. Uterine tone noted at time of delivery and after 3 minutes, 6 minutes, 9 minutes, 12 minutes, 2 hours, 12 hours.

Secondary Outcome Measures

Name	Time	Method
1)Demographic data	2)Uterine tone

Trial Locations

Locations (1)

PDU Govt Medical College Rajkot; 🇮🇳 Rajkot, GUJARAT, India

PDU Govt Medical College Rajkot

🇮🇳Rajkot, GUJARAT, India

Dr Kalrav Rawal

Principal investigator

9016055443

kalravrawal@gmail.com