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Clinical Trials/NCT07268014
NCT07268014
Recruiting
Not Applicable

The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial

Selcuk University1 site in 1 country151 target enrollmentStarted: December 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
151
Locations
1
Primary Endpoint
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.

Overview

Brief Summary

The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial

Detailed Description

The study is a randomized controlled trial. It will be conducted at Konya City Hospital between December 2025 and June 2026. A total of 151 primiparous pregnant women will be included in the study (intervention group n=75, control group n=76). The intervention group will receive a pelvic floor exercise program, while the control group will not perform any pelvic floor exercises. Data will be collected using a personal information form, a pre-labor and post-labor follow-up form, and the Michigan Incontinence Severity Index.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Registered in the hospital's prenatal school and actively participating in the 3-day training sessions,
  • Aged between 18 and 35 years,
  • Between 28 and 30 weeks of gestation,
  • Having a singleton and low-risk pregnancy,
  • Primiparous (expecting their first birth),
  • Voluntarily agreeing to participate by signing the written informed consent form,
  • Able to read, understand, and communicate in Turkish.

Exclusion Criteria

  • Those who have previously given birth vaginally or by cesarean section (multiparous women),
  • Those with multiple pregnancies,
  • Those who conceived through assisted reproductive techniques,
  • Those diagnosed with serious obstetric or medical complications during pregnancy (e.g., preeclampsia, gestational diabetes, risk of preterm birth),
  • Those with chronic constipation or cough,
  • Those who are overweight or obese,
  • Those with chronic or recurrent urinary tract infections,
  • Those with a history of psychiatric diagnosis or currently receiving psychiatric treatment,
  • Those with a diagnosis of or treatment for urinary incontinence,
  • Those unable to regularly attend the education sessions or who discontinue the program,

Outcomes

Primary Outcomes

Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.

Time Frame: 7 month

Sociodemographic information of pregnant women will be collected through surveys, compared, and reported.

Comparison of obstetric characteristics of pregnant women before the training with a questionnaire.

Time Frame: 7 month

Obstetric data of pregnant women will be collected through questionnaires, compared, and reported.

Comparison of delivery methods among pregnant women across groups.

Time Frame: 7 month

Labor and postpartum data will be collected, compared, and reported using a follow-up form.

Comparison of the severity of episiotomy in pregnant women between groups.

Time Frame: 7 month

Pregnancy and postpartum follow-up data will be collected, compared, and reported using a form.

Comparison of the Michigan Incontinence Severity Index for pregnant women between groups.

Time Frame: 7 month

The Michigan Incontinence Severity Index (M-ISI) will be administered to pregnant women. The scale consists of three subscales: stress incontinence, urge incontinence, and pad use/discomfort. Each subscale is scored separately. The RM-ISI ranges from 0 to 40 points (min-max), a higher score indicates more severe symptoms/discomfort for the relevant subscale.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seyhan Çankaya

Assoc. Prof. Seyhan Çankaya

Selcuk University

Study Sites (1)

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