A pilot randomised controlled trial to determine the effect of a physiological (step) versus a standard action (slope) labour progress lines on the rate of spontaneous vaginal birth amongst low risk women in labour for the first time

Not Applicable

Completed

• Conditions: ormal Labour; Normal Labour; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12614000786695
• Lead Sponsor: Prof Sue Kildea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Nulliparous women in spontaneous labour who are:
* At term (between 37 and 41 weeks plus 6 days gestation) with a singleton pregnancy, a cephalic (head down) presentation and cervical dilatation of 4cm or greater
* Equal to or greater than 18 years of age and able to provide informed consent
* Defined as ‘low risk’ i.e. no history of: stillbirth or neonatal death, three or more consecutive miscarriages, previous fetal death in utero, previous preterm birth (less than 32 weeks), previous mid-trimester loss/cervical incompetence/cone biopsy/known uterine anomaly, previous early onset of pre-eclampsia (less than 32 weeks gestation), or rhesus iso-immunisation; no complications during the current pregnancy (such as multiple pregnancy or fetal abnormality); and no precluding medical conditions (such as cardiac disease, essential hypertension, renal disease, pre-existing diabetes, previous gestational diabetes, epilepsy, severe asthma, substance use, significant psychiatric disorders, age greater than 40 years, body mass indexless than 17 or greater than 35).

Exclusion Criteria

* Private insurance status (this refers to women who utilise their health insurance to access maternity care from an obstetrician of their choice)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of women recruited, proportion of potentially eligible women recruited and reasons women are not recruited[completion of the study];Compliance with the trial interventions and reasons for non-compliance assessed using chart audit and a tool specifically designed for the study[completion of the study];Completeness of data collection for secondary outcomes and proportion lost to follow-up[Completion of the study]