Artificial rupture of membranes versus repeat intra-vaginal prostaglandins for induction of labour: a randomised controlled trial

The effect of artificial rupture of membranes (ARM) following one dose of Prostaglandin vaginal gel (PGE2), versus ARM following repeat doses of PGE2, on time interval between induction and birth, maternal satisfaction, likelihood of obstetric intervention and adverse maternal/perinatal outcomes amongst women undergoing an induction of labour at term: a randomised controlled trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000370707

Acronym

The ARRIVaL study

Enrollment

250

Registered

2013-04-08

Start date

2010-10-01

Completion date

2014-09-01

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

Induction of labour is very common and may be associated with increased obstetric intervention. Information which helps guide the best approach to induction would potentially benefit many women and may help reduce healthcare costs. It is proposed to conduct a randomised controlled trial of women undergoing induction of labour who have commenced induction with a single dose of intravaginal Prostaglandin gel (PGE2). Women would be randomised to PGE2 arm (continue to administer further doses of PGE2 until the cervix is ripened and then perform an artificial rupture of membranes (ARM) and commence Syntocinon infusion to induce contractions) or the ARM group (perform ARM immediately or as soon as technically possible, followed by Syntocinon infusion to induce contractions).

Interventions

Women randomised to the ARM (artificial rupture of membranes) arm are to undergo ARM using an amnihook as soon as is practical from 6 hours following a single dose of vaginal 2mg (multiparas) or 1mg (nulliparas) PGE2, regardless of the Modified Bishop’s score.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

All women with live singleton pregnancies greater than or equal to 37+0 weeks planning induction of labour using intravaginal Dinoprostone (PGE2) will be suitable for inclusion in this study

Exclusion criteria

Fetus with major congenital abnormality Multiple pregnancies Intrauterine fetal death Any contraindication to vaginal birth Women <18 years Inability to consent

Outcome results