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

This study is not yet open for participant recruitment.
Verified November 2012 by Göteborg University
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01587625
First received: April 19, 2012
Last updated: November 23, 2012
Last verified: November 2012
History of Changes
  Purpose

In a randomized control trial conducted in three hospitals in the southwest of 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 < 7 at 5 minutes, 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: Syntocinon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

Resource links provided by NLM:

Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Caesarean delivery rate [ Time Frame: At birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Spontaneous vaginal birth rate [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Length of labour [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Hyper-stimulation of contractions [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Postpartum haemorrhage [ Time Frame: Two hours postpartum ] [ Designated as safety issue: Yes ]
  • Sphincter lacerations [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Epidural analgesia [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
  • Experienced labour pain [ Time Frame: Two hours postpartum ] [ Designated as safety issue: Yes ]
  • Childbirth experience [ Time Frame: 1 month posptartum ] [ Designated as safety issue: Yes ]
    Childbirth Experience Questionnaire (CEQ)

  • Apgar score [ Time Frame: Five minutes postpartum ] [ Designated as safety issue: Yes ]
  • Neonatal intensive care [ Time Frame: 1 month postpartum ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1376
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose of oxytocin infusion
High dose of oxytocin infusion
 Drug: Syntocinon
Active Comparator: Low dose of oxytocin infusion
Low dose of oxytocin infusion
 Drug: Syntocinon

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 three hospitals in the southwest of 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 < 7 at 5 minutes, 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), 688 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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587625

Contacts
Contact: Marie Berg, PhD, Professor +46 31 786 6084 marie.berg@gu.se
Contact: Lotta Selin, Master +46 520 911339 lotta.selin@vgregion.se

Locations
Sweden
Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Sweden, 41685
Contact: Ulla-Britt Wennerholm, PhD, Ass. professor         ulla-britt.wennerholm@vgregion.se    
Principal Investigator: Marie Berg, PhD, Professor            
NU Hospital Group Not yet recruiting
Trollhättan, Sweden
Contact: Lotta Selin, Master         lotta.selin@vgregion.se    
Principal Investigator: Marie Berg, PhD, professor            
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01587625     History of Changes
Other Study ID Numbers: Oxytocin high low dose
Study First Received: April 19, 2012
Last Updated: November 23, 2012
Health Authority: Sweden: Medical Products Agency

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013