Carbetocin for preventing excessive bleeding after birth.
- Conditions
- Postpartum haemorrhageMedDRA version: 17.1Level: LLTClassification code 10005128Term: Bleeding postpartumSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2014-004445-26-GB
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 30000
Participants will be eligible for the trial if:
1.They are expected to deliver vaginally
2.They have a cervical dilatation equal to or less than 6cm
3.They have a known singleton pregnancy
4.They provide written informed consent before any trial-related procedures are carried out.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1290
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28710
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Participants will be excluded from participating in the trial if they are/have:
1.In an advanced first stage of labour (>6 cm cervical dilatation) or too distressed to understand, confirm and give informed consent regardless of cervical dilatation
2.Non-emancipated minors (as per local regulations) without a guardian
3.Scheduled for a planned caesarean section
4.A birth considered as an abortion according to local guidelines
5.Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial
6.Serious cardiovascular disorders
7.Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method