Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence

NCT06812806 | Recruiting

• 1 other identifier: APD.IUP
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

During pregnancy, the strength of the pelvic floor muscles may decrease, which can lead to musculoskeletal changes that may facilitate the onset of urinary incontinence. The investigators decided to conduct this study firstly to analyze, through simple ultrasound indices, how the contractile capacity of the pelvic floor muscles affects postpartum urinary incontinence; secondly to study the correlation between the use of perineal gymnastics, the incidence of postpartum urinary incontinence, and the strength of floor contraction.

Conditions

Postpartum Urinary Incontinence

Keywords

incontinence

Outcome Measures

Primary Outcomes (1)

• Evaluation of the correlation between the proportional change in antero-posterior diameter of the pelvic hiatus and the incidence of postpartum urinary incontinence

  Evaluation of the correlation between the proportional change (in percentage) in pelvic antero-posterior diameter (APD) between rest and maximal contraction of pelvic floor muscles and the incidence of postpartum urinary incontinence

  On the second day, after delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have given birth by vaginal delivery, obstetric suction, or cesarean section and who result exclusively in inpatient care during puerperium.

You may qualify if:

• age of 18 years or older
• completion of delivery by vaginal delivery, vaginal delivery with obstetric suction cup or cesarean section
• acquisition of informed consent form

You may not qualify if:

• presence of severe maternal complications (e.g., ongoing postpartum hemorrhage, severe sepsis, pulmonary embolism, heart failure).
• presence of clinically demonstrable vulvar or vaginal infection

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD

CONTACT

0512144412; aly.youssef@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 6, 2025
• Study Start: December 17, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2025

Record last verified: 2024-11

Locations

IT (1)