Maternal-Fetal RelationsNCT07268014
Effects of Pelvic Exercises on Birth and Incontinence
A study testing Pelvic Exercise Group in people with Maternal-Fetal Relations and Birth, First, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations, Birth, First, Incontinence, Urinary
- What is being tested?
- Pelvic Exercise Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial
The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial
Read the 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.
- Being tested
- Pelvic Exercise Group
- Keywords
- Pelvic Floor Exercise, Obstetric Outcomes, Urinary Incontinence, Birth, First
- Medical subject headings
- Urinary Incontinence, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Exercise GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Placebo comparator | The control group will consist of pregnant women who do not do any pelvic floor exercises. Receives: Other: Pelvic Exercise Group |
| Intervention Group | Experimental | 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. Receives: Other: Pelvic Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.
Sociodemographic information of pregnant women will be collected through surveys, compared, and reported.
Measured: 7 month
Comparison of obstetric characteristics of pregnant women before the training with a questionnaire.
Obstetric data of pregnant women will be collected through questionnaires, compared, and reported.
Measured: 7 month
Comparison of delivery methods among pregnant women across groups.
Labor and postpartum data will be collected, compared, and reported using a follow-up form.
Measured: 7 month
Comparison of the severity of episiotomy in pregnant women between groups.
Pregnancy and postpartum follow-up data will be collected, compared, and reported using a form.
Measured: 7 month
Comparison of the Michigan Incontinence Severity Index for pregnant women between groups.
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.
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal RelationsStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268014
- Sponsor's protocol ID
- 2025/1051
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Exercises During Pregnancy on Obstetric Outcomes and Urinary Incontinence: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07268014
- Acronym / sponsor ID
- 2025/1051
- Keywords
- Pelvic Floor Exercise, Obstetric Outcomes, Urinary Incontinence, Birth, First
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | Placebo comparator | Other: Pelvic Exercise GroupThe control group will consist of pregnant women who do not do any pelvic floor exercises. |
| Intervention Group | Experimental | Other: Pelvic Exercise GroupPregnant 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Exercise GroupPregnant 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. | Other | Intervention Group, No intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Exercise Group in people with Maternal-Fetal Relations and Birth, First, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey. (time frame: 7 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.