The Epi-No trial: Effect of intravaginal balloon device on levator trauma in mothers following childbirth

The Epi-No Study: Effect of antenatal intravaginal balloon device on levator trauma in mothers following childbirth

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000592246

Acronym

EpiNo

Enrollment

600

Registered

2009-07-16

Start date

2007-07-01

Completion date

Unknown

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

The EpiNo trial is trialing the use of a commercially available intravaginal balloon device in order to determine whether this device reduces the risk of major pelvic floor trauma at vaginal delivery.

Interventions

Use of intravaginal balloon device to distend pelvic floor muscle and reduce likelihood of traumas at childbirth, from 37 weeks' gestation to delivery. The patient inserts the device vaginally and inflates it intermittently, several times a day, to dilate the birth canal.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

First pregnancy progressing beyond 20 weeks, singleton, cephalic, no contraindications to normal vaginal delivery.

Exclusion criteria

Complications requiring planned Caesarean Section, multiple pregnancy, malpresentation, previous pregnancies beyond 20 weeks' gestation

Outcome results