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

NCT01263158 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2072

Last updated 2015-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Slow Labour Progress

Interventions

OTHER

Expectancy of standard oxytocin treatment

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Ryhov County Hospital

    collaborator OTHER

  • Göteborg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-10-31
Completion
2003-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263158 on ClinicalTrials.gov