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A0 study to assess safety and effectiveness of carbetocin vs oxytocin after delivery of baby in cesarean section to prevent excessive bleeding

A double blinded randomized controlled study to assess safety and effectiveness of carbetocin vs oxytocin during active management of third stage, for prevention of PPH in patients undergoing cesarean section - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062831
Enrollment
240
Registered
2024-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: CARBETOCIN: 100mcg of IV Carbetocin slowly over one minute, during active management of third stage of labour. Blood loss, need for additional uterotonics ,side effects will be noted fo

Sponsors

siddaganga medical college and research institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: willing to participate gestational age 36 weeks-41 weeks patients undergoing cesarean section

Exclusion criteria

Exclusion criteria: hypertensive pre eclampsia eclampsia ante partum hemorrhage bleeding disorders thrombocytopenia blood coagulation abnormalities cardiovascular disorders epilepsy asthma migraine renal disease liver disease general anesthesia retained placenta placenta accreta placenta previa previous pph grand multipara fibroid with pregnancy prolonged labour hypersensitivity to oxytocin or carbetocin traumatic pph

Design outcomes

Primary

MeasureTime frame
TO compare the safety and efficacy of carbetocin with oxytocin to prevent PPH during active management of third stage of labour.Timepoint: blood loss assesment intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour.

Secondary

MeasureTime frame
To compare adverse effects among both groups.Timepoint: adverse effects noted intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour.;To compare the requirement for additional uterotonics in both groupsTimepoint: need for additional uterotonics assesed intraoperatively,at 1st hour, 2nd hour post partum, 8th hour, 14th hour, 20th hour, 26th hour.

Countries

India

Contacts

Public ContactRAJANI SOMANATHAN

siddaganga medical college and research institute

kuttu2412@gmail.com8606605516

Outcome results

None listed

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