CONDISOX: Continued versus discontinued oxytocin stimulation of labour in a double-blind randomised controlled trial.
- Conditions
- Syntocinon is used for labour induction to stimulate contractions. The current recommendation is to stimulate until delivery. We hypothesize that discontinuation of Syntocinon when the active phase of labour is established will reduce risk of harm of both mother and child and labour will progress.MedDRA version: 20.0Level: LLTClassification code 10062462Term: Labor stimulationSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10023540Term: Labor inducedSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2015-002942-30-DK
- Lead Sponsor
- Regional Hospital of Randers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1700
Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin and a cervical dilatation of = 4cm).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
<18 years
Unable to read and understand the Danish language or to give informed consent
Non-cephalic presentation
Multiple gestation
Pathological fetal heart rate pattern (cardiotocogram, CTG) before Syntocinon® initiation
Fetal weight estimation > 4500 g (clinical or ultrasonic)
Subject declines participation
Gestational age less than 37 completed weeks
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