Clinical trial NCT06812806: Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence
Official title: Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postpartum Urinary Incontinence
Keywords: incontinence
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: As part of the gynecologic ultrasound that is routinely performed, a transperineal scan will be performed, at rest and during maximal contraction to measure the lower portion of the pelvic floor groove. I order tho achieve this, doctors will illustrate to participants first verbally and then with the visual aid of the ultrasound monitor, how to contract the pelvic floor muscles. Transperineal ultrasound is performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora. Such ultrasound does not involve internal investigations and is in no way painful. The duration of the additional ultrasound scan involves a few minutes. In addition, in order to assess the presence of typical symptoms of urinary incontinence, the participant will undergo a standardized validated questionnaire in the Italian language, called ICIQ-UI SF, consisting of a series of questions that will investigate the type of urinary incontinence, its severity and its impact on her quality of life in the four weeks prior to administration. After delivery, the participant's medical records will be consulted and some data regarding the participant (age, ethnicity, height, weight, BMI, parity, gestational age at the time of delivery), the delivery (duration of stage II labor, mode of delivery, any vagino-perineal laceration and its degree) and the newborn (weight and head circumference measurement) will be recorded.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of the correlation between the proportional change in antero-posterior diameter of the pelvic hiatus and the incidence of postpartum urinary incontinence
timeFrame: On the second day, after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
role: PRINCIPAL_INVESTIGATOR
References: