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A comparative study to know efficacy and safety of IM carbetocin verses IV carbetocin (drug to prevent PPH) in vaginal delivery

A COMPARATIVE STUDY OF SAFETY AND EFFICACY OF INTRAVENOUS CARBETOCIN VERSUS INTRAMUSCULAR CARBETOCIN IN PREVENTION OF POSTPARTUM HEMORRHAGE DURING VAGINAL DELIVERY - A randomized parallel group trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050468
Enrollment
134
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: A COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF INTRAVENOUS CARBETOCIN VERSUS INTRAMUSCULAR CARBETOCIN IN PREVENTION OF POSTPARTUM HEMORRHAGE DURING VAGINAL DELIVERY: GROUP1- Group 1

Sponsors

DR SWATI TALWADE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient consenting for study . 2. Term pregnancy (37 – 42 weeks of gestation) Expected to delivery vaginally

Exclusion criteria

Exclusion criteria: 1. Elective cesarean section 2. Have known allergies to Carbetocin, other Oxytocin homologs or excipients in the medicinal products used in the trial; 3. Have cardiovascular disorders 4. Hypertensive disorders 5. Have hepatic or renal disease 6. Have epilepsy 7. Women with coagulopathies 8. Women having known conditions predisposing to atonic PPH like hydramnios,multiple gestations, and prolonged labor etc. 9. Are not willing to give consent

Design outcomes

Primary

MeasureTime frame
Assessment of blood loss after administering Carbetocin both intramuscularly and intravenously By following criteria 1.Blood loss by using caliberated drape . 2.pre and post hemoglobin levels and hematocrit (48hrs) Timepoint: blood loss after administration carbetocin immediately and 48hr after delivery—

Secondary

MeasureTime frame
.Assessment of cardiovascular changes after administering Carbetocin both intramuscularly and intravenously 2. To assess the tone of uterus on scale of 1-5 3. Need for other uterotonics 4. Need for any blood transfusion 5. Retension of placenta Timepoint: 18 MONTHS—

Countries

India

Contacts

Public ContactDR SWATI TALWADE

SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER

ryaliwal@gmail.com9845152240

Outcome results

None listed

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