Clinical trial NCT06861335: Examination of the Effects of Pelvic Floor Muscle Exercises on Blood Flow in Pregnant Women
Official title: Examination of the Effects of Pelvic Floor Muscle Exercises on Vulvovaginal, Umbilical, Uterine and Middle Cerebral Artery Blood Flow in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Training
Pregnancy
Blood Flow Indexes
Keywords: pelvic floor muscle training, MCA, uterine artery, pregnancy
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
First posted: 2025-03-06
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research will be conducted on pregnant volunteers who have applied to the Department of Obstetrics and Gynecology at Dokuz Eylul University Faculty of Medicine Hospital and undergone a comprehensive examination by an Obstetrician and Gynecologist. After these participants are informed about the content of the study, a signed informed consent form will be obtained. In the study, during mutual interviews with all participants, initial assessments will include a data recording form, digital palpation and the PERFECT system to evaluate pelvic floor muscle strength and endurance, and clitoral Doppler ultrasound to evaluate vulvovaginal blood flow. Routine pregnancy assessments will also include umbilical, uterine artery, and MCA Doppler ultrasound. Participants will be divided into two groups: exercise and control. Pregnant women in the exercise group will receive an individualized pelvic floor exercise program created by a physiotherapist (individual exercise sessions will be arranged based on data obtained from each participant's pelvic floor examination), with the first session conducted with the physiotherapist, and then they will be asked to continue this as a home program. Participants will be reassessed during their routine doctor check-ups throughout the pregnancy, and the exercise program will be updated by the physiotherapist. An exercise tracking chart will be created and given to the participants for the home program, and they will be asked to fill these out daily. Pregnant women in the control group will only receive education about the pelvic floor muscles, their functions, pelvic structure, and changes in these structures during pregnancy. Assessments will be repeated from the 2nd trimester until delivery during the participants' routine doctor check-ups. The differences between these two groups in the obtained data will be examined.

Detailed description: This research will be conducted on pregnant women aged 18 and over, with their first pregnancy, who apply to the Department of Obstetrics and Gynecology at Dokuz Eylul University Faculty of Medicine Hospital. Participants will be informed about the purpose of the study and the assessment methods to be applied, and informed consent forms will be obtained from each participant. The demographic information of the participants will be recorded in the evaluation form.

The sociodemographic characteristics of the individuals will be evaluated through face-to-face interviews, and physical characteristics such as age (years), height (cm), weight (kg), BMI (kg/m²), and demographic data such as education level, occupation, and marital status will be recorded in the data recording form. In addition, past and family medical history, lifestyle habits, medical and surgical history, obstetric history, gynecological history, and pregnancy history will be questioned (Appendix 4). In the study, digital palpation with the PERFECT evaluation system will be used to assess pelvic floor muscle strength, and clitoral Doppler ultrasound will be used to assess vulvovaginal blood flow. Umbilical, uterine artery, and MCA blood flow will be measured by Doppler ultrasound during routine pregnancy check-ups. Assessments will be repeated three times from the 2nd trimester onwards, during the participants' regular doctor check-ups. After the first interview, participants will be randomized into exercise and control groups.

An individualized pelvic floor muscle exercise program will be created for each participant in the exercise group based on their digital palpation and PERFECT values, and will be taught in the first session with the physiotherapist, and they will be asked to do this as a home program. During the weeks they come for pregnancy check-ups, the pelvic floor muscles will be re-evaluated and the exercise program will be updated according to the new evaluation results. An exercise tracking chart will be created and given to control the home program, and participants will be asked to keep this daily and follow-up will be done. Pregnant women in the control group will not be given any exercise program and will continue their routine pregnancy follow-ups. All assessments will be repeated three times during their routine pregnancy check-ups. Separate WhatsApp groups will be created for the control and exercise groups. Reminders will be made in the exercise WhatsApp group to encourage regular exercise. Routine pregnancy information will be shared in the control WhatsApp group

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Having at least a primary school education
* Being pregnant for the first time
* Being in the 12th week of pregnancy or later
* Having a singleton pregnancy
* Having signed the informed voluntary consent form

Exclusion Criteria:

* Multiple pregnancies
* Pregnant women with pregnancy-related symptoms (hypertension, preeclampsia, gestational diabetes...)
* Pregnant women considered high-risk by an obstetrician
* Pregnant women at risk of premature birth, early delivery, or miscarriage
* Pregnant women diagnosed with neurological diseases
* Pregnant women with severe back pain (regularly unable to perform tasks)
* Pregnant women diagnosed with psychiatric diseases
* Pregnant women with severe cognitive impairment

Primary outcomes:
measure: uterine artery blood flow
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
measure: umbilical artery blood flow
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
measure: middle cerebral artery blood flow
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
measure: vulvovaginal blood flow
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
measure: pelvic floor muscle function
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
measure: pelvic floor muscle function
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
measure: pelvic floor muscle function
timeFrame: The first measurement will be performed between the 20th and 24th weeks of pregnancy, the second measurement between the 25th and 28th weeks of pregnancy, and the third measurement between the 35th and 38th weeks of pregnancy.
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar Univercity
Study officials:
affiliation: Dokuz Eylul University
name: Özge Çeliker Tosun, professor
role: PRINCIPAL_INVESTIGATOR
References: