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

Official title

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

Overview

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.

Interventions

• Behavioral Early individualized pelvic floor muscle training (PFMT)
  Participants receive individualized pelvic floor muscle training (PFMT) delivered by a physiotherapist from 2-3 weeks postpartum. The program is individually progressed according to recovery and aims to gradually achieve the recommended training dose of 8-10 maximal contractions held for 6-8 seconds, performed in three sets, 2-3 times daily, for at least 12 weeks. Participants receive an information booklet covering pelvic floor recovery, pain management, bowel and bladder function, relaxation,

Primary outcome measures

• Vaginal symptoms [Time frame: Participants will complete the ICIQ-VS at 6 weeks, 4, 6 and 12 months postpartum.]
• Urinary incontinence [Time frame: Participants will complete the ICIQ-UI short form at 6 weeks, 4, 6 and 12 months postpartum.]
• Bowel function [Time frame: Participants will complete the PFQ-PP at 2 and 6 weeks, 4, 6 and 12 months postpartum.]
• Changes in levator hiatus area [Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum]
• Changes in levator plate length [Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum]
• Changes in bladder neck height [Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum]
• Changes in urogenital hiatus [Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum]
• Qualitative measures for perineal body integrity [Time frame: Assessed 6 weeks and 6 months postpartum]

Secondary outcome measures (4)

• Bladder, vaginal bulge/prolapse, and sexual function. [Time frame: Participants will complete the PFQ-PP at 2 and 6 weeks, 4, 6 and 12 months postpartum.]
• Patient's global impression of improvement (PGI-I) [Time frame: Participants will complete the PGI-I 4, 6 and 12 months postpartum.]
• Pregnancy Exercise Self Efficacy Scale (P-ESES) [Time frame: Participants will complete the P-ESES at 6 weeks, 4, 6 and 12 months postpartum.]
• Pelvic floor muscle strength and tone [Time frame: Assessed at 6 weeks and 6 months postpartum]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Sweden · 2 centers

• Sahlgrenska hospital, Östra — Gothenburg
• University of Gothenburg — Gothenburg

Identifiers

NCT: NCT07430865 · 286551 · ALFGBG-1015613

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗