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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Sweden
Sahlgrenska hospital, Östra
RECRUITING
Gothenburg
University of Gothenburg
RECRUITING
Gothenburg
Contact Information
Primary
Sabine Vesting, PhD
sabine.vesting@gu.se
0046722095484
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 380
Treatments
Experimental: Early individualized pelvic floor muscle training (PFMT)
Individualized early postpartum pelvic floor muscle training starting 2-3 weeks postpartum, based on progressive overload principles. Training is progressively adapted according to tissue healing, pain, symptoms, and ultrasound findings. The target is 8-10 maximal voluntary contractions held for 6-8 seconds, performed in 3 sets, 2-3 times daily for at least 12 weeks, with progression in intensity, endurance, and motor control while prioritizing contraction quality over quantity. Load (intensity, volume, and complexity) is adjusted in response to recovery and symptom response.~Participants receive structured education, an exercise diary, and regular digital follow-ups (every second week for 3 months, then every fourth week), with additional physical visits if needed for guiding of pelvic floor muscle contraction
No_intervention: Standard postpartum care
Participants in this group receive routine postpartum care in Sweden, which typically includes 1-2 visits at the midwife center. The midwife may recommend that participants seek physiotherapy if needed. Any physiotherapy visits that occur are self-reported by participants and documented at the end of the study to evaluate the type, frequency, and content of care received. Participants do not have access to ultrasound files before the end of the study.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov