NCT01587625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,376

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2016

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

April 19, 2012

Last Update Submit

March 1, 2019

Conditions

Birth; Delayed

Keywords

Delayed labourdystociaoxytocin augmentationprimiparous womenchildbirthchildbirth experienceprogress

Outcome Measures

Primary Outcomes (1)

  • Caesarean delivery rate

    data from clinical records

    At birth

Secondary Outcomes (10)

  • Spontaneous vaginal birth rate

    At birth

  • Length of labour

    At birth

  • Hyper-stimulation of contractions

    At birth

  • Postpartum haemorrhage

    Two hours postpartum

  • Sphincter lacerations

    At birth

  • +5 more secondary outcomes

Study Arms (2)

High dose of oxytocin infusion

EXPERIMENTAL

Oxytocin: High dose infusion

Drug: Oxytocin

Low dose of oxytocin infusion

ACTIVE COMPARATOR

Oxytocin: Low dose infusion

Drug: Oxytocin

Interventions

OxytocinDRUG
High dose of oxytocin infusionLow dose of oxytocin infusion

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Non-Swedish speaking women
  • previous uterine surgery
  • intrauterine growth retardation \> - 22%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, 41685, Sweden

Location

NU Hospital Group

Trollhättan, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 33176392DERIVED

  • 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.

    PMID: 30341003DERIVED

MeSH Terms

Conditions

Dystocia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2012

First Posted

April 30, 2012

Study Start

August 1, 2013

Primary Completion

June 9, 2016

Study Completion

October 8, 2016

Last Updated

March 4, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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.

Locations

SE(2)