High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour (OxyHighLow)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ]
- Spontaneous vaginal birth rate [ Time Frame: At birth ]
- Length of labour [ Time Frame: At birth ]
- Hyper-stimulation of contractions [ Time Frame: At birth ]
- Postpartum haemorrhage [ Time Frame: Two hours postpartum ]
- Sphincter lacerations [ Time Frame: At birth ]
- Epidural analgesia [ Time Frame: At birth ]
- Experienced labour pain [ Time Frame: Two hours postpartum ]
- Childbirth experience [ Time Frame: 1 month posptartum ]Childbirth Experience Questionnaire (CEQ)
- Apgar score [ Time Frame: Five minutes postpartum ]
- Neonatal intensive care [ Time Frame: 1 month postpartum ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: High dose of oxytocin infusion
High dose of oxytocin infusion
Active Comparator: Low dose of oxytocin infusion
Low dose of oxytocin 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 three hospitals in the southwest of 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 < 7 at 5 minutes, 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), 688 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
|Contact: Marie Berg, PhD, Professor||+46 31 786 email@example.com|
|Contact: Lotta Selin, Master||+46 520 firstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Sweden, 41685|
|Contact: Ulla-Britt Wennerholm, PhD, Ass. professor email@example.com|
|Principal Investigator: Marie Berg, PhD, Professor|
|NU Hospital Group||Recruiting|
|Contact: Lotta Selin, Master firstname.lastname@example.org|
|Principal Investigator: Marie Berg, PhD, professor|