Incontinence, UrinaryNCT06185439
Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence
A study testing Prenatal Pilates Assisted Childbirth Preparation Training in people with Incontinence, Urinary and Training Group, Sensitivity, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled trial was made to determine the effectiveness of prenatal pilates-supported childbirth preparation training on birth outcomes, incontinence during pregnancy, and the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Urinary, Training Group, Sensitivity
- What is being tested?
- Prenatal Pilates Assisted Childbirth Preparation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2022to 1 Aug 2022
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35,
- Being in the 28th-30th week of pregnancy
- Having a singleton pregnancy
- Being nulliparous
Who cannot join
- Having chronic constipation
- Having a chronic cough
- Having a history of any psychiatric condition, multiple sclerosis, spinal cord injury, congenital or acquired anatomical abnormalities of the urogenital tract, bladder malignancy
- Being overweight and obese
- Giving birth outside of 37-42 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludağ Üniversitesi
Nilufer, Bursa, 16059
About this study
Official title: The Effect of Prenatal Pilates-Supported Childbirth Training on Birth Outcomes and Incontinence: A Randomized Controlled Study
A randomized controlled trial was made to determine the effectiveness of prenatal pilates-supported childbirth preparation training on birth outcomes, incontinence during pregnancy, and the postpartum period.
Read the detailed description
One of the risk factors for the development of stress incontinence in women is pregnancy and childbirth. This problem increases as pregnancy progresses and continues in the postpartum period.
It was tested the hypothesis, there is no difference in the development of urinary incontinence in the prenatal and postpartum periods among women who receive Pilates-assisted childbirth preparation training and women who were into the usual care.
- Conditions
- Incontinence, Urinary, Training Group, Sensitivity
- Being tested
- Prenatal Pilates Assisted Childbirth Preparation Training
- Keywords
- Pregnancy pilates, Urinary incontinence, childbirth training
- Medical subject headings
- Urinary Incontinence, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Pilates Assisted Childbirth Preparation TrainingBehavioural
Also called Experimental: Study group
Training was given twice a week for two hours a day (one hour of theory, one An hour of exercise = 45 minutes of pregnant plates and 15 minutes of breathing exercises) total eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Study group | Experimental | In this study, the study group was provided with prenatal pilates-assisted childbirth preparation training and follow-up, in addition to the usual care provided by health professionals. Receives: Behavioral: Prenatal Pilates Assisted Childbirth Preparation Training |
| Control group | No intervention | The control group was in the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-intervention
During the prenatal period, evaluation of incontinence score with the Michigan Incontinence Severity Index Form (minimum score : 0- maximum score:40) during an assessment at registration before intervention (before education and pilates). A score higher than the given cut-off values indicates that the severity of incontinence is worsening.
Measured: During assessment at registration
Intervention- Childbirth training program and prenatal pilates intervention
Evaluation of incontinence score with the Michigan Incontinence Severity Index Form ( minimum score: 0 -maximum score: 40 cut of the point: 7 and above ) after the intervention. Questions 1st-3th on the MISIF scale indicate stress incontinence severity, 4th-6th questions measure the severity of urge incontinence, and 1st-8th questions measure the severity of incontinence. There points above indicate stress incontinence and the total score of questions 4-6 indicates 5 points and above for urge incontinence severity.A score higher than the given cut-off values indicates that the severity of incontinence is worsening.
Measured: Immediately after at the end of the eight-week prenatal pilates-supported birth preparation training
Secondary outcomes (1)
Postpaortum period- Post-discharge
Evaluation of incontinence score with the Michigan Incontinence Severity Index Form( minimum score: 0 - maximum score: 40; seven and above was accepted as the cut-off point) after discharge, after one month of childbirth. Questions 1st-3th on the Michigan Incontinence Severity Index Form indicate stress incontinence severity, 4th-6th questions measure the severity of urge incontinence, and 1st-8th questions measure the severity of incontinence. There points and above indicate stress incontinence and the total score of questions 4-6 indicates 5 points and above for urge incontinence severity.A score higher than the given cut-off values indicates that the severity of incontinence is worsening.
Measured: Post-discharge - one month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start2 Mar 2022
- Primary completion1 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incontinence, UrinaryStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Buran, Aydin Adnan Menderes University
- Investigators
- Gonca Buran, Asis Prof, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185439
- Sponsor's protocol ID
- 2011-KAEK-26/193
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Mazzarino M, Kerr D, Morris ME. Pilates program design and health benefits for pregnant women: A practitioners' survey. J Bodyw Mov Ther. 2018 Apr;22(2):411-417. doi: 10.1016/j.jbmt.2017.05.015. Epub 2017 May 31.
PubMed 29861243Sargin MA, Yassa M, Taymur BD, Ergun E, Akca G, Tug N. Adaptation and validation of the Michigan Incontinence Severity Index in a Turkish population. Patient Prefer Adherence. 2016 May 26;10:929-35. doi: 10.2147/PPA.S106209. eCollection 2016.
PubMed 27307713Ahlund S, Rothstein E, Radestad I, Zwedberg S, Lindgren H. Urinary incontinence after uncomplicated spontaneous vaginal birth in primiparous women during the first year after birth. Int Urogynecol J. 2020 Jul;31(7):1409-1416. doi: 10.1007/s00192-019-03975-0. Epub 2019 May 28.
PubMed 31139858Chang SR, Lin WA, Chang TC, Lin HH, Lee CN, Lin MI. Risk factors for stress and urge urinary incontinence during pregnancy and the first year postpartum: a prospective longitudinal study. Int Urogynecol J. 2021 Sep;32(9):2455-2464. doi: 10.1007/s00192-021-04788-w. Epub 2021 Apr 9.
PubMed 33835213Dias NT, Ferreira LR, Fernandes MG, Resende APM, Pereira-Baldon VS. A Pilates exercise program with pelvic floor muscle contraction: Is it effective for pregnant women? A randomized controlled trial. Neurourol Urodyn. 2018 Jan;37(1):379-384. doi: 10.1002/nau.23308. Epub 2017 May 23.
PubMed 28543751Buran G, Erim Avci S. The effect of pregnancy pilates-assisted childbirth preparation training on urinary incontinence and birth outcomes: a randomized-controlled study. Arch Gynecol Obstet. 2024 Nov;310(5):2725-2735. doi: 10.1007/s00404-024-07653-5. Epub 2024 Jul 31.
PubMed 39083052
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prenatal Pilates-Supported Childbirth Training on Birth Outcomes and Incontinence: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06185439
- Acronym / sponsor ID
- 2011-KAEK-26/193
- Conditions
- Incontinence, Urinary, Training Group, Sensitivity
- Keywords
- Pregnancy pilates, Urinary incontinence, childbirth training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 29 Dec 2023 (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.
A randomized controlled trial was made to determine the effectiveness of prenatal pilates-supported childbirth preparation training on birth outcomes, incontinence during pregnancy, and the postpartum period.
Detailed description
One of the risk factors for the development of stress incontinence in women is pregnancy and childbirth. This problem increases as pregnancy progresses and continues in the postpartum period.
It was tested the hypothesis, there is no difference in the development of urinary incontinence in the prenatal and postpartum periods among women who receive Pilates-assisted childbirth preparation training and women who were into the usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Experimental: Study group | Experimental | Behavioral: Prenatal Pilates Assisted Childbirth Preparation TrainingIn this study, the study group was provided with prenatal pilates-assisted childbirth preparation training and follow-up, in addition to the usual care provided by health professionals. |
| Control group | No intervention | –The control group was in the usual care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-35,
- Being in the 28th-30th week of pregnancy
- Having a singleton pregnancy
- Being nulliparous
Key exclusion criteria (5 listed)
- Having chronic constipation
- Having a chronic cough
- Having a history of any psychiatric condition, multiple sclerosis, spinal cord injury, congenital or acquired anatomical abnormalities of the urogenital tract, bladder malignancy
- Being overweight and obese
- Giving birth outside of 37-42 weeks
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 |
|---|---|---|
| Prenatal Pilates Assisted Childbirth Preparation TrainingAlso: Experimental: Study groupTraining was given twice a week for two hours a day (one hour of theory, one An hour of exercise = 45 minutes of pregnant plates and 15 minutes of breathing exercises) total eight weeks. | Behavioural | Experimental: Study group |
Primary outcome
Pre-intervention
Time frame: During assessment at registration
During the prenatal period, evaluation of incontinence score with the Michigan Incontinence Severity Index Form (minimum score : 0- maximum score:40) during an assessment at registration before intervention (before education and pilates). A score higher than the given cut-off values indicates that the severity of incontinence is worsening.
Intervention- Childbirth training program and prenatal pilates intervention
Time frame: Immediately after at the end of the eight-week prenatal pilates-supported birth preparation training
Evaluation of incontinence score with the Michigan Incontinence Severity Index Form ( minimum score: 0 -maximum score: 40 cut of the point: 7 and above ) after the intervention. Questions 1st-3th on the MISIF scale indicate stress incontinence severity, 4th-6th questions measure the severity of urge incontinence, and 1st-8th questions measure the severity of incontinence. There points above indicate stress incontinence and the total score of questions 4-6 indicates 5 points and above for urge incontinence severity.A score higher than the given cut-off values indicates that the severity of incontinence is worsening.
1 secondary outcome
Postpaortum period- Post-discharge
Time frame: Post-discharge - one month after birth
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 3 Jan 2024.
- Background: PubMed 29861243Mazzarino M, Kerr D, Morris ME. Pilates program design and health benefits for pregnant women: A practitioners' survey. J Bodyw Mov Ther. 2018 Apr;22(2):411-417. doi: 10.1016/j.jbmt.2017.05.015. Epub 2017 May 31.
- Background: PubMed 27307713Sargin MA, Yassa M, Taymur BD, Ergun E, Akca G, Tug N. Adaptation and validation of the Michigan Incontinence Severity Index in a Turkish population. Patient Prefer Adherence. 2016 May 26;10:929-35. doi: 10.2147/PPA.S106209. eCollection 2016.
- Results publication: PubMed 31139858Ahlund S, Rothstein E, Radestad I, Zwedberg S, Lindgren H. Urinary incontinence after uncomplicated spontaneous vaginal birth in primiparous women during the first year after birth. Int Urogynecol J. 2020 Jul;31(7):1409-1416. doi: 10.1007/s00192-019-03975-0. Epub 2019 May 28.
- Results publication: PubMed 33835213Chang SR, Lin WA, Chang TC, Lin HH, Lee CN, Lin MI. Risk factors for stress and urge urinary incontinence during pregnancy and the first year postpartum: a prospective longitudinal study. Int Urogynecol J. 2021 Sep;32(9):2455-2464. doi: 10.1007/s00192-021-04788-w. Epub 2021 Apr 9.
- Results publication: PubMed 28543751Dias NT, Ferreira LR, Fernandes MG, Resende APM, Pereira-Baldon VS. A Pilates exercise program with pelvic floor muscle contraction: Is it effective for pregnant women? A randomized controlled trial. Neurourol Urodyn. 2018 Jan;37(1):379-384. doi: 10.1002/nau.23308. Epub 2017 May 23.
- Derived from this study: PubMed 39083052Buran G, Erim Avci S. The effect of pregnancy pilates-assisted childbirth preparation training on urinary incontinence and birth outcomes: a randomized-controlled study. Arch Gynecol Obstet. 2024 Nov;310(5):2725-2735. doi: 10.1007/s00404-024-07653-5. Epub 2024 Jul 31.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Gonca Buran, Asis Prof principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Pilates Assisted Childbirth Preparation Training in people with Incontinence, Urinary and Training Group, Sensitivity, run by Aydin Adnan Menderes 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 4 inclusion and 5 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 3 Jan 2024. 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. 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?
Pre-intervention (time frame: During assessment at registration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185439, which also lists 6 linked publications.
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 3 Jan 2024.