High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour (OxyHighLow)

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.

Study Overview

• Status: Completed
• Conditions: Birth; Delayed
• Intervention / Treatment: Drug: Oxytocin

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.

• Study Type: Interventional
• Enrollment (Actual): 1376
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41685
    • Sahlgrenska University Hospital
  • Trollhättan, Sweden
    • NU Hospital Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caesarean delivery rate	data from clinical records	At birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous vaginal birth rate	data from clinical records	At birth
Length of labour	data from clinical records	At birth
Hyper-stimulation of contractions	data from clinical records	At birth
Postpartum haemorrhage	data from clinical records	Two hours postpartum
Sphincter lacerations	data from clinical records	At birth
Epidural analgesia	data from clinical records	At birth
Experienced labour pain	VAS 0-100 mm where 100 is highest pain level	Two hours postpartum
Childbirth experience	Childbirth Experience Questionnaire (CEQ)	1 month postpartum
Apgar score	data from clinical records	Five minutes postpartum
Neonatal intensive care	data from clinical records	1 month postpartum

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region

Publications and helpful links

General Publications

• Selin L, Berg M, Wennerholm UB, Dencker A. Dosage of oxytocin for augmentation of labor and women's childbirth experiences: A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 May;100(5):971-978. doi: 10.1111/aogs.14042. Epub 2021 Jan 28.
• Selin L, Wennerholm UB, Jonsson M, Dencker A, Wallin G, Wiberg-Itzel E, Almstrom E, Petzold M, Berg M. High-dose versus low-dose of oxytocin for labour augmentation: a randomised controlled trial. Women Birth. 2019 Aug;32(4):356-363. doi: 10.1016/j.wombi.2018.09.002. Epub 2018 Oct 16.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 9, 2016
• Study Completion (Actual): October 8, 2016

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: dystocia; childbirth; childbirth experience; oxytocin augmentation; progress; Delayed labour; primiparous women
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: Oxytocin high low dose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data for primary and secondary outcome measures from the two groups will be submitted to the Swedish National Data Service (Svensk Nationell Datatjänst, SND), a national authority responsible for administrating sharing of research data.