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Labour Augmentation by Means of Oxytocin - Obstetric Outcome and Women's Experiences

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263158
First Posted: December 20, 2010
Last Update Posted: August 11, 2015
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.
Collaborators:
Sahlgrenska University Hospital, Sweden
Ryhov County Hospital
Information provided by (Responsible Party):
Göteborg University
  Purpose

Slow labour progress is common in nulliparous women and is associated with childbirth complications and negative birth experiences. Oxytocin augmentation is widely used to treat slow labour despite associated risks for the fetus. An ongoing debate concerns whether oxytocin should be administered directly or postponed after arrested labour. The overall aim is to study labour progress in healthy nulliparous women and to compare childbirth outcomes and experiences in women randomised to expectant versus early oxytocin augmentation for slow labour progress.

The hypothesis is that it is to early to start oxytocin treatment when labour progress has been slow for 2 to 3 hours in healthy women having their first baby and therefore beneficial for childbirth outcomes to postpone oxytocin for another 3 hours. In this randomised controlled trial nulliparous women with a normal pregnancy, spontaneous onset of active labor at term, and a cervical dilatation of 4 - 9 centimetres on admission to the delivery ward were included (n=2,072). All women whose labour did not progress after amniotomy (n=630) were randomly allocated either to labour augmentation by oxytocin infusion (Early oxytocin, n=314) or to postponement of oxytocin augmentation for another three hours (Expectant, n=316). One month postpartum the women received a postal questionnaire concerning their experiences of labour and birth. All participating women gave their informed consent. Maternal and neonatal outcomes like mode of delivery, postpartum haemorrhage, perinatal lacerations, low Apgar score, need of neonatal intensive care and maternal experiences of childbirth were compared between the randomised groups.


Condition Intervention
Slow Labour Progress Other: Expectancy of standard oxytocin treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Mode of delivery (spontaneous vaginal, instrumental vaginal or caesarean delivery)

Secondary Outcome Measures:
  • Postpartum haemorrhage
  • Sphincter lacerations
  • Need of neonatal intensive care
  • Maternal experiences of childbirth

Enrollment: 2072
Study Start Date: October 1998
Study Completion Date: December 2003
Arms Assigned Interventions
Experimental: Expectant group
Arrest in labour progress for 2-3 hours and no progress after amniotomy. Expectancy of standard oxytocin treatment for 3 hours.
Other: Expectancy of standard oxytocin treatment
No Intervention: Early oxytocin group
Arrest in labour progress for 2-3 hours and no progress after amniotomy. Oxytocin treatment started within 20 minutes.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Nulliparity Normal pregnancy 37+0 - 41+6 weeks Single foetus Cephalic presentation Spontaneous onset of active labour Informed consent

Exclusion Criteria:

Prelabour rupture of membranes Serious maternal disease Fetal intrauterine death

  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): NCT01263158


Locations
Sweden
Institute of Health and Care Sciences, University of Gothenburg
Gothenburg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Ryhov County Hospital
  More Information

Publications:
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01263158     History of Changes
Other Study ID Numbers: L586-97
First Submitted: December 17, 2010
First Posted: December 20, 2010
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Göteborg University:
randomised controlled trial
nulliparous women
slow labour progress
prolonged labour
oxytocin augmentation
operative delivery
childbirth experience

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