Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women

NCT ID: NCT05004402

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-04

Study Completion Date

2023-12-31

Brief Summary

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Background: Pregnancy and childbirth are factors that affect a woman's pelvic floor. Pelvic floor disorders (PFD) often occur in the perinatal period. Symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the quality of life and sexual activity. Patient education that includes both the anatomy and function of the pelvic floor, as well as information on the prevention of PFD during pregnancy and postpartum is an important part of the prevention of these dysfunctions. Diastasis recti abdominis (DRA) is another common musculoskeletal issue related to pregnancy and postpartum period. In addition to the cosmetic consequences, it can be associated with abdominal pain, the occurrence of pelvic floor dysfunction and a negative correlation with the image of a woman's own body.

Material and Methods: Primiparous women after vaginal delivery will be invited to this study. The study will consist of three stages. First phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (PERFECT scheme, OXFORD scale, Reissing scale), palpation and ultrasound examination of diastasis recti abdominis. After 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. Third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated.

Objectives: The aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. Our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of PFD and/or DRA 3 months postpartum.

Expected results: Results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in Poland. Additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. Prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. To our knowledge this will be the first study in this area conducted in Poland.

Detailed Description

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Conditions

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Pelvic Floor Disorders Diastasis Recti

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primiparous women

Primiparous women after vaginal delivery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Vaginal delivery between 38-42 weeks of pregnancy
* First delivery
* Agreement to participate
* Good command of spoken and written Polish

Exclusion Criteria

* Contraindications for the examination of the pelvic floor muscles (postpartum hematoma of the perineum, extensive perineal swelling, perineal wound dehiscence, bladder catheterization).
* Lack of consent to participate in the study
* Lack of good command of spoken and written Polish
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Żelazna Medical Centre, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Małgorzata Starzec-Proserpio, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Midwifery, Centre of Postgraduate Medical Education, Warsaw, Poland

Locations

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St. Sophia's Specialist Hospital

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Małgorzata Starzec-Proserpio, PhD

Role: CONTACT

503383584 ext. +48

Agata Szymańska, MSc

Role: CONTACT

888496947 ext. +48

Facility Contacts

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Agata Szymańska, MSc

Role: primary

888496947 ext. +48

Other Identifiers

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PN/56/2021

Identifier Type: -

Identifier Source: org_study_id

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