Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence

Incontinence, Urinary Clinical Trial

Official title:

The Effect of Prenatal Pilates-Supported Childbirth Training on Birth Outcomes and Incontinence: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06185439
• Other study ID #: 2011-KAEK-26/193
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2023
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary
• Training Group, Sensitivity
• Urinary Incontinence

Intervention

Behavioral:
• Prenatal Pilates Assisted Childbirth Preparation Training
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.

Locations

Country	Name	City	State
Turkey	Bursa Uludag Üniversitesi	Nilüfer	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 — View Citation

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 — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Birth Outcomes	To evaluate the effect of prenatal pilates-assisted birth preparation training on the duration of birth (hours, minutes), the analgesia/anesthesia used, and the mode of birth rate (number and percentage) with the questionnaire	After labor in 48 hour
Primary	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
Primary	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	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.	Post-discharge - one month after birth