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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: January 15, 2014
Last verified: January 2014

April 19, 2012
January 15, 2014
August 2013
November 2016   (final data collection date for primary outcome measure)
Caesarean delivery rate [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01587625 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Birth; Delayed
Drug: Syntocinon
  • Experimental: High dose of oxytocin infusion
    High dose of oxytocin infusion
    Intervention: Drug: Syntocinon
  • Active Comparator: Low dose of oxytocin infusion
    Low dose of oxytocin infusion
    Intervention: Drug: Syntocinon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1376
December 2016
November 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact: Marie Berg, PhD, Professor +46 31 786 6084 marie.berg@gu.se
Contact: Lotta Selin, Master +46 520 911339 lotta.selin@vgregion.se
Sweden
 
NCT01587625
Oxytocin high low dose
Yes
Göteborg University
Göteborg University
Vastra Gotaland Region
Not Provided
Göteborg University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP