OxyHighLow: High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

Sponsor

Göteborg University (Other)

Overall Status

Completed

CT.gov ID

NCT01587625

Collaborator

Vastra Gotaland Region (Other)

1,376

Enrollment

Locations

Arms

38.2

Duration (Months)

688

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Birth; Delayed	Drug: Oxytocin	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1376 participants

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jun 9, 2016

Actual Study Completion Date :

Oct 8, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High dose of oxytocin infusion Oxytocin: High dose infusion	Drug: Oxytocin
Active Comparator: Low dose of oxytocin infusion Oxytocin: Low dose infusion	Drug: Oxytocin

Arm

Intervention/Treatment

Experimental: High dose of oxytocin infusion

Oxytocin: High dose infusion

Drug: Oxytocin

Active Comparator: Low dose of oxytocin infusion

Oxytocin: Low dose infusion

Drug: Oxytocin

Outcome Measures

Primary Outcome Measures

Caesarean delivery rate [At birth]
data from clinical records

Secondary Outcome Measures

Spontaneous vaginal birth rate [At birth]
data from clinical records
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
Epidural analgesia [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