Clinical trial NCT05004402: Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women
Official title: Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Disorders
Diastasis Recti
Lead sponsor: Żelazna Medical Centre, LLC
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primiparous women after vaginal delivery

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
timeFrame: 24-72 hours postpartum
measure: Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
timeFrame: 12-16 weeks postpartum
measure: Ultrasound measurement of inter-recti distance (IRD)
timeFrame: 24-72 hours postpartum
measure: Ultrasound measurement of inter-recti distance (IRD)
timeFrame: 12-16 weeks postpartum
measure: Polish version of the Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 12-16 weeks postpartum
measure: Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)
timeFrame: 12-16 weeks postpartum
measure: Polish Version of the Female Sexual Function Index (FSFI)
timeFrame: 12-16 weeks postpartum
Secondary outcomes:
measure: Palpation evaluation of pelvic muscle tone with Reissing scale
timeFrame: 24-72 hours postpartum
measure: Palpation evaluation of pelvic muscle tone with Reissing scale
timeFrame: 12-16 weeks postpartum
measure: Palpable measurement of inter-recti distance (IRD)
timeFrame: 24-72 hours postpartum
measure: Palpable measurement of inter-recti distance (IRD)
timeFrame: 12-16 weeks postpartum
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: St. Sophia's Specialist Hospital
Study officials:
affiliation: Department of Midwifery, Centre of Postgraduate Medical Education, Warsaw, Poland
name: Małgorzata Starzec-Proserpio, PhD
role: PRINCIPAL_INVESTIGATOR
References: