Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence

NCT06185439 | Completed

• 1 other identifier: 2011-KAEK-26/193
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incontinence, Urinary; Training Group, Sensitivity

Keywords

Pregnancy pilates; Urinary incontinence; childbirth training

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately after at the end of the eight-week prenatal pilates-supported birth preparation training

Secondary Outcomes (1)

• Postpaortum period- Post-discharge

  Post-discharge - one month after birth

Other Outcomes (1)

• Birth Outcomes

  After labor in 48 hour

Study Arms (2)

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.

Behavioral: Prenatal Pilates Assisted Childbirth Preparation Training

Control group

NO INTERVENTION

The control group was in the usual care.

Interventions

Prenatal Pilates Assisted Childbirth Preparation Training BEHAVIORAL

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.

Also known as: Experimental: Study group

Experimental: Study group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: for pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-35,
• Being in the 28th-30th week of pregnancy
• Having a singleton pregnancy
• Being nulliparous

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Bursa Uludağ Üniversitesi

Nilufer, Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 29861243 BACKGROUND

• 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.

  PMID: 27307713 BACKGROUND

• 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.

  PMID: 31139858 RESULT

• 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.

  PMID: 33835213 RESULT

• 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.

  PMID: 28543751 RESULT

• 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.

  PMID: 39083052 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Hypersensitivity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Gonca Buran, Asis Prof

  Uludag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data will be collected by the assistant researcher and entered into the SPSS program as A and B groups. Analyzes will be performed by the principal investigator who is blind to the groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 29, 2023
• Study Start: March 2, 2022
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)