Clinical Trial: The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers

Brief Summary: The purpose of this study is to evaluate if the rate of emergency caesarean section can be reduced if adhering to a dynamic labour progression curve compared to a static progression curve for first time mothers without jeopardising maternal and neonatal outcomes

Detailed Summary:

  1. Introduction The increasing rate of emergency caesarean sections in developed countries is of great concern as it is associated with adverse outcomes for mother and infant. The rate of caesarean sections for first time mothers with a singleton foetus in a vertex position and spontaneous onset of labour at term has increased from 5.7 % to 9.2 % in Norway. The most common indication for emergency caesarean sections is Labour dystocia, even if there is no consensus on criteria for the diagnosis.

    Labour dystocia is characterised by abnormally slow progress of labour and is among the most common challenges of birth care especially in first time mothers. When the labour progression is assessed to be prolonged according to current guidelines, labour dystocia is treated by amniotomy followed by oxytocin infusion to augment uterus contractions. Oxytocin is a potent drug and classified by the Institute for Safe Medication Practices in the USA as one of 12 medications which is "bearing heightened risk of harm".

    In Norway the guidelines for expected progression of labour is based on modifications of Friedman's curve of cervical dilatation, a linear labour progression curve developed in 1953. Contemporary research by Zhang shows that the dilatation of the cervix can be substantially slower than earlier expected, especially at an early stage of labour.

    Hypothesis: By adhering to the guideline for labour progression presented by Zhang, the rate of emergency caesarean sections in first time mothers will decrease compared to adhering to the guideline for labour progression based on a modified Friedman's curve, without jeopardising the maternal and neonatal outcomes.

  2. Same as current

    Current Secondary Outcome: The use of oxytocin for augmenting uterus contractions [ Time Frame: 14 months ]

    The rate of women augmented with oxytocin including indication for initiating oxytocin infusion, cervical dilatation at onset of augmentation and length of augmentation


    Original Secondary Outcome: Same as current

    Information By: Ostfold Hospital Trust

    Dates:
    Date Received: August 18, 2014
    Date Started: December 2014
    Date Completion: December 2018
    Last Updated: January 4, 2017
    Last Verified: January 2017