A pilot randomised controlled trial to determine the effect of two designs of partographs, including labour progress lines, on the rate of spontaneous vaginal birth amongst low risk women in labour for the first time: The Partograph Trial

For women in labour for the first time does a partograph with a graduated dystocia line compared to a standard sloping action line increase the likelihood of a spontaneous vaginal birth: Pilot Partograph study 2

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000445572

Enrollment

246

Registered

2015-05-08

Start date

2016-01-12

Completion date

2018-11-10

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this pilot study is to test the procedures for a larger trial that will compare two different tools (partographs) for measuring progress in labour. In particular we aim to achieve a compliance rate of 85% with both the intervention and control arms of the trial. The outcomes will inform any necessary changes to the main study protocol. If no substantial changes are required the data from this pilot study will be incorporated into the results of the main study

Interventions

The Dystocia line partogram is a visual tool that uses a graduated (stepped) line to indicate whether cervical dilatation, determined by vaginal assessment at regular intervals, is slower than a mean of 0.5cm per hour. The tool is administered by a midwife and the results of vaginal assessments are recorded on the partograph every four hours or as clinically indicated.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 40 Years

Healthy volunteers

Yes

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 isoimmunisation; 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)

Outcome results