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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
April 19, 2012
April 30, 2012
August 7, 2017
August 2013
June 9, 2016   (Final data collection date for primary outcome measure)
Caesarean delivery rate [ Time Frame: At birth ]
data from clinical records
Caesarean delivery rate [ Time Frame: At birth ]
Complete list of historical versions of study NCT01587625 on ClinicalTrials.gov Archive Site
  • 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
  • Spontaneous vaginal birth rate [ Time Frame: At birth ]
  • Length of labour [ Time Frame: At birth ]
  • Hyper-stimulation of contractions [ Time Frame: At birth ]
  • Postpartum haemorrhage [ Time Frame: Two hours postpartum ]
  • Sphincter lacerations [ Time Frame: At birth ]
  • Epidural analgesia [ Time Frame: At birth ]
  • Experienced labour pain [ Time Frame: Two hours postpartum ]
  • Childbirth experience [ Time Frame: 1 month posptartum ]
    Childbirth Experience Questionnaire (CEQ)
  • Apgar score [ Time Frame: Five minutes postpartum ]
  • Neonatal intensive care [ Time Frame: 1 month postpartum ]
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Birth; Delayed
Drug: Oxytocin
  • Experimental: High dose of oxytocin infusion
    Oxytocin: High dose infusion
    Intervention: Drug: Oxytocin
  • Active Comparator: Low dose of oxytocin infusion
    Oxytocin: Low dose infusion
    Intervention: Drug: Oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1376
October 8, 2016
June 9, 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
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01587625
Oxytocin high low dose
Yes
Not Provided
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.
Göteborg University
Göteborg University
Vastra Gotaland Region
Not Provided
Göteborg University
August 2017

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