Pessary insertion directly post partum: does it reduce pelvic organ prolapse symptoms one year postpartum compared with standard care? A randomised controlled trial
Not Applicable
Recruiting
- Conditions
- N39.3CystoceleStress incontinenceN81.1
- Registration Number
- DRKS00007897
- Lead Sponsor
- Charité Campus Benjamin Franklin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 302
Inclusion Criteria
Primipara, vaginal birth, physical and mental health, able to attend follow up examination
Exclusion Criteria
Death of Fetus, severe birth trauma, postpartum hysterectomy, severe pain, unable to attend follow up, neurological diseases, previous pelvic floor operation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pelvic floor function (Prolapse symptoms) 12 months postpartum (assessment with validated Pelvic Floor Questionnaire)
- Secondary Outcome Measures
Name Time Method Prolapse (POPQ) and pelvic floor symptoms 6 weeks and one year postpartum (German version of Australian Pelvic Floor Questionnaire)<br>Interim analysis scheduled at 6 weeks to assess<br>pelvic floor function