drugset / Trial / NCT01587625

High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

NCT01587625 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. Primary outcome is caesarean delivery rate. Secondary outcomes are: Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.

Timeline

Start
2013-08
Primary completion
2016-06-09
Completion
2016-10-08

Outcome

Missed primary endpoint

paper Caesarean section rates did not differ between groups (12.4% and 12.3%, 95% Confidence Interval -3.7 to 3.8). PMID 30341003 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide 3.3 iu Other
Subject Oxytocin Peptide 6.6 iu Other

Indications

No indication recorded.