- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268014
Effects of Pelvic Exercises on Birth and Incontinence
The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seyhan Çankaya, PhD
- Phone Number: 05054300733
- Email: seyhane32@gmail.com
Study Locations
-
-
-
Konya, Turkey (Türkiye), 42250
- Recruiting
- Seyhan Çankaya
-
Contact:
- Seyhan Çankaya, PhD
- Phone Number: 05054300733
- Email: seyhane32@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: No intervention
The control group will consist of pregnant women who do not do any pelvic floor exercises.
|
Pregnant women in the exercise group will participate in an eight-week pelvic floor exercise program. The program begins with a face-to-face group training session during a childbirth preparation class at Konya City Hospital, in groups of 15, led by a midwife. Training covers pelvic floor anatomy, correct muscle identification, Kegel exercises, breathing, relaxation techniques, and exercise demonstrations. Following the session, participants will perform exercises three times a week for eight weeks, including Kegels, breathing-coordinated contractions, pelvic floor exercises in various positions, core stabilization exercises, and integration into daily activities. Weekly video materials will support proper exercise and motivation, and participants will record their practice in an exercise diary. At the end, experiences will be evaluated, and guidance for postpartum continuation will be provided. |
|
Experimental: Intervention Group
Pregnant women in the exercise group will participate in an eight-week pelvic floor exercise program. The program begins with a face-to-face group training session during a childbirth preparation class at Konya City Hospital, in groups of 15, led by a midwife. Training covers pelvic floor anatomy, correct muscle identification, Kegel exercises, breathing, relaxation techniques, and exercise demonstrations. Following the session, participants will perform exercises three times a week for eight weeks, including Kegels, breathing-coordinated contractions, pelvic floor exercises in various positions, core stabilization exercises, and integration into daily activities. Weekly video materials will support proper exercise and motivation, and participants will record their practice in an exercise diary. At the end, experiences will be evaluated, and guidance for postpartum continuation will be provided. |
Pregnant women in the exercise group will participate in an eight-week pelvic floor exercise program. The program begins with a face-to-face group training session during a childbirth preparation class at Konya City Hospital, in groups of 15, led by a midwife. Training covers pelvic floor anatomy, correct muscle identification, Kegel exercises, breathing, relaxation techniques, and exercise demonstrations. Following the session, participants will perform exercises three times a week for eight weeks, including Kegels, breathing-coordinated contractions, pelvic floor exercises in various positions, core stabilization exercises, and integration into daily activities. Weekly video materials will support proper exercise and motivation, and participants will record their practice in an exercise diary. At the end, experiences will be evaluated, and guidance for postpartum continuation will be provided. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 month
|
|
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.
|
7 month
|
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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.
|
7 month
|
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Comparison of the severity of episiotomy in pregnant women between groups.
Time Frame: 7 month
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Pregnancy and postpartum follow-up data will be collected, compared, and reported using a form.
|
7 month
|
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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.
|
7 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Pelvic Floor Disorders
Other Study ID Numbers
- 2025/1051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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