Birth; Delayed
Conditions
Keywords
Delayed labour, dystocia, oxytocin augmentation, primiparous women, childbirth, childbirth experience, progress
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy nulliparous women * singleton pregnancy * normal pregnancy * cephalic presentation * spontaneous onset of active labour * at term (37 - 42weeks gestation) * delay or arrest of active labour
Exclusion criteria
* Non-Swedish speaking women * previous uterine surgery * intrauterine growth retardation \> - 22% * malpresentation at time of inclusion * intrapartal hemorrhage at time of inclusion * nonreassuring fetal-heart pattern at time of inclusion * meconium at time of inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caesarean delivery rate | At birth | data from clinical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of labour | At birth | data from clinical records |
| Hyper-stimulation of contractions | At birth | data from clinical records |
| Postpartum haemorrhage | Two hours postpartum | data from clinical records |
| Sphincter lacerations | At birth | data from clinical records |
| Spontaneous vaginal birth rate | At birth | data from clinical records |
| Experienced labour pain | Two hours postpartum | VAS 0-100 mm where 100 is highest pain level |
| Childbirth experience | 1 month postpartum | Childbirth Experience Questionnaire (CEQ) |
| Apgar score | Five minutes postpartum | data from clinical records |
| Neonatal intensive care | 1 month postpartum | data from clinical records |
| Epidural analgesia | At birth | data from clinical records |
Countries
Sweden