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Clinical Trials/EUCTR2014-001948-37-GB
EUCTR2014-001948-37-GB
Active, not recruiting
Phase 1

Intramuscular oxytocics: A multi-centre randomised comparison study of intramuscular Carbetocin, Syntocinon and Syntometrine for the third stage of labour following vaginal birth - IMox study

orth Bristol NHS Trust0 sites6,285 target enrollmentSeptember 30, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
orth Bristol NHS Trust
Enrollment
6285
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 30, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
orth Bristol NHS Trust

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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