Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06279455 |
| Other study ID # |
E-74555795-050.01.04-392120 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 5, 2022 |
| Est. completion date |
October 30, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was conducted to evaluate the effects of pelvic floor muscle exercises during
pregnancy on sexual function, lower urinary tract symptoms and birth process. The research
was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul
University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed
to determine the number of samples to be included in the study. It was determined that 29
pregnant women should be included in each group (experimental and control). Considering the
possibility of data loss, 50 pregnant women were included in each group. As a result of the
exclusion of 8 women who withdrew from participating in the study, 5 women due to risky
pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean
delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in
the control group were obtained. Pregnant women in the experimental group were gestational
aged 18-20. Two sessions of training were given on female reproductive and urinary system
anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic
floor muscle exercises, using the "Pelvic Floor Health & Sexual Life Training Booklet during
Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher
between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle
exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of
pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the
researcher. Pregnant women in the control group were not given any training and were
routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient
clinic are examined by nurses, with their vital signs taken and anamnesis taken by the
physician. Recommendations are made regarding the complaints of pregnant women. Non-stress
tests are routinely applied to pregnant women who are at the 36th week of pregnancy and
above.
Description:
Purpose of the research This study was conducted to evaluate the effects of pelvic floor
muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth
process.
Type of Research This research is of randomized controlled prospective type.
Place and Time the Research The research was conducted at the Pregnancy Outpatient Clinic of
Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital, Department of
Gynecology and Obstetrics, between December 2022 and October 2023.
Population and Sample of the Research The population of the research consisted of pregnant
women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa
Cerrahpasa Faculty of Medicine Hospital, Department of Gynecology and Obstetrics. G*Power
(3.1.9.7) Program was used to determine the sample number of pelvic floor muscle exercise
(experimental group) and control groups. The Female Sexual Function Index was taken as the
main parameter in the study. As a result of the power analysis performed with α=0.05 and
power of 95% (effect size: 0.7), the sample was calculated as 29 pregnant women for each
group. Considering that there may be losses during the study period, it was decided to
include a total of 100 pregnant women between the ages of 18-40, including the experimental
group (n = 50) and the control group (n = 50).
The numbers to be included in the sample were determined using the randomization program
(www.randomizer.org).
As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women
due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due
to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant
women in the control group were obtained.
Research data were collected with "Personal Information Form" (between 18-20th week of
pregnancy), "Female Sexual Function Index" (between 18-20th week of pregnancy and 32nd week
of pregnancy), "Mid-term Evaluation Form" (26th week of pregnancy), "International
Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Long Form
(ICIQ-FLUTS LF)" (between 18-20th week of pregnancy and 32nd week of pregnancy), "Birth
Process Follow-up Form" (between 3-7th days after birth) and "Pelvic Floor Muscle Exercise
Follow-up Form" (20-32 between weeks of pregnancy).
