NCT07430865 The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation

Eligibility & Interventions

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This trial targets 380 participants in total. It began in 2026-04-07 with a primary completion date of 2028-12-31.

Brief Summary

The goal of this observational study with an embedded pilot clinical trial is to learn how the pelvic floor recovers after vaginal childbirth and whether early individualized pelvic floor muscle training can improve recovery in people who experience pelvic floor symptoms after vaginal delivery. The main questions it aims to answer are: * How do pelvic floor muscles and surrounding tissues change and recover during the first year after vaginal childbirth? * How are these structural changes and their recovery related to urinary, bowel, and vaginal symptoms? * In participants with pelvic floor symptoms after vaginal childbirth, does early individualized pelvic floor muscle training improve symptoms and support structural recovery compared with usual care? Researchers will compare participants who receive the early pelvic floor muscle training to those receiving standard postpartum care to see if the training helps improve pelvic floor function and reduce symptoms. Participants will: Attend clinic visits at six weeks, and six months after childbirth Complete questionnaires about urinary, bowel, and vaginal symptoms, as well as physical activity and quality of life at six weeks, and four, six months, and twelve months after childbirth Undergo clinical pelvic floor assessments, including vaginal palpation of muscle strength, tone, and perineal body stability Have ultrasound examinations of the pelvic floor to assess muscle structure, tissue integrity, and perineal body morphology For those in the pilot trial, participate in an early, individualized pelvic floor muscle training program This study will provide important information about how the pelvic floor heals after childbirth, how structural changes are linked to symptoms, and whether early personalized training can help prevent long-term problems.

Eligibility Criteria

Inclusion Criteria: * Individuals (over 18 years) who delivered a single child vaginally between 37 and 41 weeks of gestation, with a birthweight of at least 2500 grams. Exclusion Criteria: * Delivered via c-section * Multiparous with previous third- or fourth-degree tears * History of major urogynecological surgery * Known neurological disorder (e.g., stroke, multiple sclerosis) that could affect the assessment outcomes * Severe connective tissue disorders that could affect the assessment outcomes * New pregnancy of more than 6 weeks during the study period * Pain with vaginal penetration, tampon use, or gynecological examinations that would prevent participation in assessments * Visible signs for wound complications assessed via REEDA tool (redness, oedema, ecchymosis, discharge, approximation) will exclude the participants from the first ultrasound assessment and vaginal palpation.

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