NCT07268014

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 24, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

Pelvic Floor ExerciseObstetric OutcomesUrinary IncontinenceBirth, First

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    7 month

Study Arms (2)

No intervention

PLACEBO COMPARATOR

The control group will consist of pregnant women who do not do any pelvic floor exercises.

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.

Other: Pelvic Exercise Group

Interventions

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.

Intervention GroupNo intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyhan Çankaya

Konya, 42250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary IncontinencePelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy Complications

Central Study Contacts

Seyhan Çankaya, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations