UnknownNot Applicable

Perineorraphy Versus Pelvic Floor Exercise - a Randomized Trial

Sweden70 participantsStarted 2015-09

Plain-language summary

The perineal body is commonly injured during labor. It is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. The aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor * height of perineum 2 cm or less. * A least 6 months post partum * stopped "exclusive breastfeeding" * no indication for other gynecological surgical procedure Exclusion Criteria: * history of 4th degree laceration * connective tissue disorder (Systemic lupus erythematosus, Sjögrens syndrome, Polymyalgia rheumatica, Marfans syndrome, Ehlers-Danlos syndrome) * current use of systemic corticosteroids * diabetes mellitus * suspect occult sphincter tear on ultrasound * history of previous urogynecological operation

What they're measuring

Patient Global Impression of Improvement (PGI-1)

Timeframe: 6 months after intervention (operation or start of pelvic floor training)

Trial details

NCT IDNCT02545218

SponsorStockholm South General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06

View on ClinicalTrials.gov More Perineal Tear Resulting From Childbirth trials