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

Not Applicable

Recruiting

• Conditions: Pelvic floor trauma in childbirth; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12609000592246
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evator trauma as assessed by translabial ultrasound[3 months postpartum]

Secondary Outcome Measures

Name	Time	Method
>20% increase in hiatal dimensions at rest as assessed by translabial ultrasound[3 months, 2 years postpartum];>20% increase in hiatal dimensions on Valsalva as assessed by translabial ultrasound[3 months, 2 years postpartum]