Labour Augmentation by Means of Oxytocin - Obstetric Outcome and Women's Experiences
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|ClinicalTrials.gov Identifier: NCT01263158|
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : August 11, 2015
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 or disease||Intervention/treatment||Phase|
|Slow Labour Progress||Other: Expectancy of standard oxytocin treatment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2072 participants|
|Masking:||None (Open Label)|
|Study Start Date :||October 1998|
|Actual Study Completion Date :||December 2003|
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.
- Mode of delivery (spontaneous vaginal, instrumental vaginal or caesarean delivery)
- Postpartum haemorrhage
- Sphincter lacerations
- Need of neonatal intensive care
- Maternal experiences of childbirth
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
|Institute of Health and Care Sciences, University of Gothenburg|
|Gothenburg, Sweden, 40530|