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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004402
• Other study ID #: PN/56/2021
• Status: Recruiting
• Start date: August 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Zelazna Medical Centre, LLC
• Contact: Malgorzata Starzec-Proserpio, PhD
• Phone: 503383584
• Email: m.starzec[@]szpitalzelazna.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis Recti
• Diastasis, Muscle
• Pelvic Floor Disorders

Locations

Country	Name	City	State
Poland	St. Sophia's Specialist Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Zelazna Medical Centre, LLC

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palpation examination of pelvic floor muscles with the use of PERFECT Scheme	Assesment of pelvic floor muscles with the use of PERFECT Scheme.	24-72 hours postpartum
Primary	Palpation examination of pelvic floor muscles with the use of PERFECT Scheme	Assesment of pelvic floor muscles with the use of PERFECT Scheme.	12-16 weeks postpartum
Primary	Ultrasound measurement of inter-recti distance (IRD)	Measurement of inter-recti distance (IRD) using the ultrasound.	24-72 hours postpartum
Primary	Ultrasound measurement of inter-recti distance (IRD)	Measurement of inter-recti distance (IRD) using the ultrasound.	12-16 weeks postpartum
Primary	Polish version of the Pelvic Floor Distress Inventory (PFDI-20)	Condition-specific questionnaire will be used to assess how pelvic floor disorders affect quality of life. It consist of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from 3 scales are summarized to achieve summary score (0-300).	12-16 weeks postpartum
Primary	Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)	Condition-specific questionnaire, will be used to assess impact of pelvic floor disorders on quality of life (daily activities, relationships and emotions). It consists of 3 scales which are scored 0-100. The results from 3 scales are summarized to achieve the summary score (0-300). Higher numbers indicate greater impact.	12-16 weeks postpartum
Primary	Polish Version of the Female Sexual Function Index (FSFI)	Assessment of sexual function in women, in 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) scored 0-6. The summarized maximum score is 36. Results =27,50 indicate risk for sexual dysfunction.	12-16 weeks postpartum
Secondary	Palpation evaluation of pelvic muscle tone with Reissing scale	Assessment of muscle tone. Reissing scale for palpation evaluation of muscle tone with use of 7-level grade where -3 means hypotonic, 0 -normotonus and +3 hypertonic muscles.	24-72 hours postpartum
Secondary	Palpation evaluation of pelvic muscle tone with Reissing scale	Assessment of muscle tone. Reissing scale for palpation evaluation of muscle tone with use of 7-level grade where -3 means hypotonic, 0 -normotonus and +3 hypertonic muscles.	12-16 weeks postpartum
Secondary	Palpable measurement of inter-recti distance (IRD)	Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.	24-72 hours postpartum
Secondary	Palpable measurement of inter-recti distance (IRD)	Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.	12-16 weeks postpartum