Room Temperature Stable Carbetocin for Preventing Blood Loss after Delivery

Effect of Carbetocin RTS vs Oxytocin for Preventing Postpartum Hemorrhage on Post-Delivery Hemoglobin: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/06/006996

Enrollment

1400

Registered

2016-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: O720- Third-stage hemorrhage

Interventions

Intervention1: Carbetocin Room Temperature Stable: Carbetocin RTS 100 Î¼g/mL IM will be administered as a single IM dose of 100 Î¼g (in a 1 mL solution)within one minute of birth of the baby after as

Eligibility

Inclusion criteria

Inclusion criteria: 1. Expected to deliver vaginally 2. Cervical dilatation equal to or less than 6 cm. 3. Able to provide written informed consent before any trial related activities are carried out.

Exclusion criteria

Exclusion criteria: 1. In advanced first stage of labour ( > 6 cm cervical dilatation). 2. Too distressed to understand, confirm and give informed consent regardless of cervical dilatation. 3. Non-emancipated minors (as per local regulations) without a guardian. 4. Planned/Emergency caesarean section. 5. Birth considered an abortion according to local guidelines. 6. Allergic to Carbetocin, other oxytocin homologues or excipients. 7. Serious cardiovascular disorders. 8. Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum hemorrhage) or mental disorder

Design outcomes

Primary

Measure	Time frame
Post-delivery (48-72 hours) Hemoglobin level adjusted for pre-delivery Hemoglobin.Timepoint: Post-delivery (48-72 hours) Hemoglobin level adjusted for pre-delivery Hemoglobin.	—

Secondary

Measure	Time frame
1 Blood loss of 500mL or more within one hour 2 Blood loss of 1,000mL or more within one hour 3 Additional uterotonics 4 Blood transfusion 5 Manual removal of placenta 6 Additional surgical procedures 7 Maternal death 8 Composite outcome of maternal death or severe morbidity up to time of discharge. 9 Incidence and severity of adverse or serious adverse events up to time of discharge. Timepoint: Postpartum day 3.	—

Measure

Time frame

1 Blood loss of 500mL or more within one hour 2 Blood loss of 1,000mL or more within one hour 3 Additional uterotonics 4 Blood transfusion 5 Manual removal of placenta 6 Additional surgical procedures 7 Maternal death 8 Composite outcome of maternal death or severe morbidity up to time of discharge. 9 Incidence and severity of adverse or serious adverse events up to time of discharge. Timepoint: Postpartum day 3.

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Countries

India

Contacts

Public ContactDr Shivaprasad S Goudar

KLE Universitys J N Medical College

swati.goudar90@gmail.com7760875261

Outcome results

None listed

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