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Clinical Trials/NCT02221427
NCT02221427Active, not recruitingNot Applicable

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

Ostfold Hospital Trust2 sites in 1 country6,582 target enrollmentStarted: December 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
6,582
Locations
2
Primary Endpoint
Rate of emergency caesarean section

Study Overview

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 Description

  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. Background and status of knowledge Traditionally the labour process is divided in two stages; the first stage and the second stage. The first stage is divided in two phases; the latent phase and the active phase, the latent phase is defined from onset of labour until the cervix is dilated four centimetres with 3-4 painful contractions per ten minutes. The active phase is defined from a cervix dilatation of four centimetres until fully dilated. The second stage is divided in two phases; the deceleration phase where the baby's head is decelerating towards the pelvic floor and the expulsion phase where the mother is actively pushing the baby out.

To visualize the progression of labour, the status of the cervix dilatation is traditionally measured and recorded throughout labour on a graphic curve often called a partogram. The partogram is widely used internationally and facilitates that midwives' and doctors' can monitor labour progression, and together with criteria for labour dystocia, consequently carry out necessary interventions.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Robson group I:First time mothers with a singleton foetus in a vertex position, in spontaneous onset of labour between gestational week 37-42

Exclusion Criteria

  • Robson groups 2-10

Outcomes

Primary Outcomes

Rate of emergency caesarean section

Time Frame: 14 months

Secondary Outcomes

  • The use of oxytocin for augmenting uterus contractions(14 months)

Investigators

Sponsor
Ostfold Hospital Trust
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stine Bernitz

Midwife, PhD

Ostfold Hospital Trust

Study Sites (2)

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