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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587625
First Posted: April 30, 2012
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
  Purpose
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 Intervention
Birth; Delayed Drug: Oxytocin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Caesarean delivery rate [ Time Frame: At birth ]
    data from clinical records


Secondary Outcome Measures:
  • Spontaneous vaginal birth rate [ Time Frame: At birth ]
    data from clinical records

  • Length of labour [ Time Frame: At birth ]
    data from clinical records

  • Hyper-stimulation of contractions [ Time Frame: At birth ]
    data from clinical records

  • Postpartum haemorrhage [ Time Frame: Two hours postpartum ]
    data from clinical records

  • Sphincter lacerations [ Time Frame: At birth ]
    data from clinical records

  • Epidural analgesia [ Time Frame: At birth ]
    data from clinical records

  • Experienced labour pain [ Time Frame: Two hours postpartum ]
    VAS 0-100 mm where 100 is highest pain level

  • Childbirth experience [ Time Frame: 1 month postpartum ]
    Childbirth Experience Questionnaire (CEQ)

  • Apgar score [ Time Frame: Five minutes postpartum ]
    data from clinical records

  • Neonatal intensive care [ Time Frame: 1 month postpartum ]
    data from clinical records


Enrollment: 1376
Study Start Date: August 2013
Study Completion Date: October 8, 2016
Primary Completion Date: June 9, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587625


Locations
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41685
NU Hospital Group
Trollhättan, Sweden
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
  More Information

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01587625     History of Changes
Other Study ID Numbers: Oxytocin high low dose
First Submitted: April 19, 2012
First Posted: April 30, 2012
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Göteborg University:
Delayed labour
dystocia
oxytocin augmentation
primiparous women
childbirth
childbirth experience
progress

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs