Continued versus discontinued oxytocin stimulation of labour in a doubleblind randomised controlled trial.

Phase 1

• Conditions: Syntocinon is used for labour induction or labour augmentation tostimulate contractions. The current recommendation is to stimulate untildelivery. We hypothesize that discontinuation of Syntocinon when theactive phase of labour is established will reduce risk of harm of bothmother and child and labour will progress.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-002942-30-NL
• Lead Sponsor: Regional Hospital of Randers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-18
• Study Completion: 2020-07-02
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1200

Inclusion Criteria

Women stimulated with Syntocinon® infusion for induction of labour
(with or without cervical priming by prostaglandin) or for augmentation
of slow labour in the latent phase (regular contractions for at least four
hours 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

Exclusion Criteria

<18 years and >45 years
Unable to read and understand the Danish language or to give informed consent
Cervical dilatation > 4 cm
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