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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Prenatal Pilates Assisted Childbirth Preparation Training
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06185439
Study groupRoleWhat they receive
Experimental: Study groupExperimentalIn 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 groupNo interventionThe control group was in the usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)

  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.

  1. First posted29 Dec 2023
  2. Study start2 Mar 2022
  3. Primary completion1 May 2022
  4. Study completion1 Aug 2022

Resources

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)
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 29861243

  • Sargin 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 27307713

  • Ahlund 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 31139858

  • Chang 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 33835213

  • Dias 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 28543751

  • Buran 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

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.

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