High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour (OxyHighLow)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour|
- Caesarean delivery rate [ Time Frame: At birth ]data from clinical records
- Spontaneous vaginal birth rate [ Time Frame: At birth ]data from clinical records
- Length of labour [ Time Frame: At birth ]data from clinical records
- Hyper-stimulation of contractions [ Time Frame: At birth ]data from clinical records
- Postpartum haemorrhage [ Time Frame: Two hours postpartum ]data from clinical records
- Sphincter lacerations [ Time Frame: At birth ]data from clinical records
- Epidural analgesia [ Time Frame: At birth ]data from clinical records
- Experienced labour pain [ Time Frame: Two hours postpartum ]VAS 0-100 mm where 100 is highest pain level
- Childbirth experience [ Time Frame: 1 month postpartum ]Childbirth Experience Questionnaire (CEQ)
- Apgar score [ Time Frame: Five minutes postpartum ]data from clinical records
- Neonatal intensive care [ Time Frame: 1 month postpartum ]data from clinical records
|Study Start Date:||August 2013|
|Study Completion Date:||October 8, 2016|
|Primary Completion Date:||June 9, 2016 (Final data collection date for primary outcome measure)|
Experimental: High dose of oxytocin infusion
Oxytocin: High dose infusion
Active Comparator: Low dose of oxytocin infusion
Oxytocin: Low dose infusion
The aim is to compare starting dose and increment of amount of oxytocin for augmentation of delayed labour to determine whether augmentation by high dose of oxytocin improves labour outcomes compared with a low dose of oxytocin, without effecting neonatal outcomes or birth experiences negatively.
Delay in labour, also described as poor progress, due to ineffective uterine contraction is a major problem in modern obstetric care and one of the main reasons for the increased rate of caesarean deliveries, in particular among nulliparous women. Infusion with synthetic oxytocin is a commonly used treatment of hypotonic uterine contractions. Despite the widespread use of oxytocin no consensus exists regarding the dosage of oxytocin, both starting dose and increment of amount of oxytocin.
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. The expected outcome is a decreased caesarean section rate and increased rate of spontaneous vaginal delivery for women with high dose of oxytocin for augmentation, without affecting neonatal outcomes or childbirth experiences negatively.
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). Based on a sample size calculation (α=0.05, β=0.80), 1045 women will be needed in each group. Analysis will be performed by the intention to treat.
Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587625
|Sahlgrenska University Hospital|
|Göteborg, Sweden, 41685|
|NU Hospital Group|