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to evaluate the prophylactic effect of carbitoicn and oxytocin in pph in vaginal delivery

A COMPARATIVE STUDY TO EVALUATE THE EFFECT OF PROPHYLACTIC CARBETOCIN AND OXYTOCIN IN PREVENTION OF POSTPARTUM HEMORRHAGE AFTER NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLLED TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082455
Enrollment
42
Registered
2025-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None listed

Interventions

Intervention1: CARBITOCIN: Prophylactic Carbetocin (100mcg IV over 1 minute) is as good as Oxytocin (10 units IM and 10 units infusion in 1 pint RL) in the prevention of PPH after normal vaginal deliv

Sponsors

DMMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All PRIMI and 2nd GRAVIDA with pervious 1 FTND and who can undergo normal vaginal delivery

Exclusion criteria

Exclusion criteria: a) Assisted vaginal delivery b) LSCS c) VBAC d) Multiple pregnancy e) History of pregnancy induced Hypertension and epilepsy f) Fetal macrosomia and fetal malformations associated with polyhydramnios g) Presence of uterine fibroids, presence of placenta previa h) Women with cardiac, renal or liver diseases i) Women with history of hypersensitivity to carbetocin or oxytocin j) Severe CPD k) Bleeding disorders

Design outcomes

Primary

MeasureTime frame
There is significant reduction in blood loss using carbitocin,there is no much change in HBTimepoint: Blood loss less than 500ml No extra use of uterotonics No much reduction in HB HB will be evalated on post natal day 2 blood loos will be calculated after placental separation in immediate post partum

Secondary

MeasureTime frame
Prophylactic Carbetocin (100mcg IV over 1 minute) is as good as Oxytocin (10 units IM & 10 units infusion in 1 pint RL) in the prevention of PPH after normal vaginal delivery.Timepoint: blood loss will be calculated after delivery of placenta HB will be evaluated on post natal day 2 Both drugs are good for prevention of PPH after vgainal delivery Carbetocin is good as oxytocin for PPH ,Only single dose is needed in carbetocin immediately after delivering the placenta

Countries

India

Contacts

Public ContactDr Jeena Darsan

DR MOOPENS MEDICAL COLLEGE

drelizabethjoseph@gmail.com06238241480

Outcome results

None listed

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