Birth; Delayed Clinical Trial
Official title:
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04888013 -
Birth Environment and Childbirth-stress, Control & Outcome
|
N/A |