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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050426
Enrollment
70
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Carbetocin: Carbetocin 100 mcg single i.v. bolus would be given over 1 minute on delivery of the foetus and the clamping of the umbilical cord. Control Intervention1: Oxytocin: Oxytocin

Sponsors

PDU Govt Medical College Rajkot
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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) Timepoint: 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

MeasureTime frame
1)Demographic data 2)Uterine tone 3)Additional uterotonic used 4)Additional side effectsTimepoint: 1)Maternal Age(years) and Gestational Age(weeks) 2)Likert Scale at time of delivery, after 3 minutes, after 6 minutes, after 9 minutes, after 12 minutes after 2 hours, after 12 hours(Likert scale 0-4, 0-floppy,1-soft, 2-poorly contracted, 3-well contracted, 4-hard rock) 3)Additional uterotonics used 4)Nausea, Vomitting, Flushing, Tachycardia, Hypotension, Headache, Chestpain

Countries

India

Contacts

Public ContactDr Kalrav Rawal

PDU Govt Medical College,Rajkot

kalravrawal@gmail.com9016055443

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026