NCT07430865

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

The RECOVER Study - Recovery of Pelvic Floor Structure and Function After Vaginal Childbirth- a Longitudinal Cohort Study With an Embedded Pilot Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The RECOVER study is a prospective observational cohort with an embedded pilot randomized controlled trial (RCT) designed to investigate postpartum recovery of the pelvic floor and the effects of early, individualized pelvic floor training. Pelvic floor disorders, such as urinary incontinence, vaginal heaviness, and pelvic organ prolapse, are common after vaginal childbirth and can significantly reduce quality of life and limit physical activity. Vaginal deliveries are the primary risk factor, yet little is known about how anatomical changes in different pelvic floor structures, including the levator ani muscles, perineal body, and urethral support, relate to symptoms and function. The study recruits approximately 380 participants at week 36 of pregnancy and follows them for 12 months postpartum. Data collection occurs at 6 weeks, 4 months, 6 months, and 12 months, including self-reported questionnaires, ultrasound and clinical assessments. The pilot RCT randomizes 124 symptomatic participants to either standard postpartum care or early (2-3 weeks after delivery) individualized physiotherapy. Ultrasound assessments, including transperineal and endovaginal imaging, are used to evaluate the pelvic floor's morphology, such as bladder neck height, urogenital and levator ani hiatus, levator ani tears, and perineal body integrity. Clinical assessments include vaginal palpation of pelvic floor muscle strength, tone and perineal body integrity. Pelvic floor symptoms are measured by validated questionnaires. Primary outcomes are urinary, vaginal, and bowel symptoms, as well as pelvic floor morphology. Secondary outcomes include self-efficacy for physical activity, adherence to training, and perceived improvements. Data are analyzed to identify associations between anatomical changes, symptoms, obstetric factors, and intervention effects. This research aims to provide detailed understanding of postpartum pelvic floor recovery, identify factors influencing recovery, and evaluate the feasibility and preliminary effectiveness of early, individualized pelvic floor interventions. Findings are expected to inform best practices for postpartum care, guide individualized rehabilitation, and help prevent long-term pelvic floor dysfunction, thereby supporting lifelong pelvic health and physical activity.

Conditions

• Urinary Incontinence
• Pelvic Organ Prolapse (POP)
• Bowel Symptoms
• Postpartum
• Physiotherapy and Rehabilitation
• Pelvic Floor Muscle Training
• Pelvic Floor
• Recovery

Interventions

Type	Name	Description
BEHAVIORAL	Early individualized pelvic floor muscle training (PFMT)	Participants receive individualized pelvic floor muscle training (PFMT) delivered by a physiotherapist starting 2-3 weeks postpartum. The program must include pelvic floor exercises at least three times per week, with three sets of 8-10 contractions per session, progressing from light to stronger and endurance-focused contractions. Physiotherapists may also include relaxation techniques, hip, back, and abdominal exercises, breathing exercises, and advice on general physical activity according to each participant's needs. Treatment is adapted based on ultrasound images and a video of pelvic floor contractions, allowing physiotherapists to tailor exercises to any detected tears or weaknesses. All interventions are documented in a checklist to record which components were delivered. Ultrasound files and videos are provided for physiotherapists to guide treatment, but the assessor remains blinded to group allocation.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Sweden