A study comparing three drugs given immediately after child birth, used to prevent excessive maternal bleeding (post-partum haemorrhage).

Phase 1

• Conditions: Post partum haemorrhage; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2014-001948-37-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 6285

Inclusion Criteria

- 18 years of age, or older, at time of delivery
- Singleton pregnancy
- Vaginal birth (spontaneous and instrumental)
- Any gestation

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6285
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Significant antepartum haemorrhage (>50ml) or suspected or proven placenta abruption
- Maternal coagulation disorder
- Multiple pregnancy (twins or higher order)
- Intrauterine fetal death
- Patients who would decline blood products if required (ie: Jehovah's Witnesses - clinicians may have a lower threshold for administering additional prophylactic uterotonic drugs to these patients)
- Known or suspected hypertensive disorders, including pre-eclampsia, pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled), and patients with hypertension in labour
- Patients with peripheral, hepatic or cardiac disease
- Patients with an allergy or hypersensitivity to any of the active ingredients in Carbetocin, Syntometrine or Syntocinon

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified