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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000786695

Enrollment

Registered

2014-07-24

Start date

2015-01-16

Completion date

2015-05-18

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This project aims to test the feasbility of a trial into a new type of partograph for measuring progress in labour with the goal of increasing rates of spontaneous vaginal birth (SVB), improving maternal and infant health outcomes and reducing maternity costs. The partograph is a paper based tool recommended by the World Health Organisation (WHO), and universally used to measure progress in labour and to assist in the diagnosis and management of prolonged labour. Research suggests that a newly designed partograph could be more appropriate to the high resource setting and may result in increased SVB rates without harmful effects on mother or baby. We hypothesise that such a partograph will result in fewer women requiring augmentation (medical acceleration of labour) and increase the rate of SVBs. This trial will also determine the effect of the new partograph on analgesic use, operative birth (caesarean section and instrumental), maternal and infant outcomes. Appropriate management in labour is critical to achieving optimal SVB rates

Interventions

The 'physiological' 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 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 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)

Outcome results