Room Temperature Stable Carbetocin for Preventing Blood Loss after Delivery
- Conditions
- Health Condition 1: O720- Third-stage hemorrhage
- Registration Number
- CTRI/2016/06/006996
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1799
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1 Blood loss of 500mL or more within one hour <br/ ><br>2 Blood loss of 1,000mL or more within one hour <br/ ><br>3 Additional uterotonics <br/ ><br>4 Blood transfusion <br/ ><br>5 Manual removal of placenta <br/ ><br>6 Additional surgical procedures <br/ ><br>7 Maternal death <br/ ><br>8 Composite outcome of maternal death or severe morbidity up to time of discharge. <br/ ><br>9 Incidence and severity of adverse or serious adverse events up to time of discharge. <br/ ><br>Timepoint: Postpartum day 3.