Clinical trial NCT06185439: Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence
Official title: The Effect of Prenatal Pilates-Supported Childbirth Training on Birth Outcomes and Incontinence: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urinary
Training Group, Sensitivity
Keywords: Pregnancy pilates
Urinary incontinence
childbirth training
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-intervention
timeFrame: During assessment at registration
measure: Intervention- Childbirth training program and prenatal pilates intervention
timeFrame: Immediately after at the end of the eight-week prenatal pilates-supported birth preparation training
Secondary outcomes:
measure: Postpaortum period- Post-discharge
timeFrame: Post-discharge - one month after birth
Other outcomes:
measure: Birth Outcomes
timeFrame: After labor in 48 hour
Locations:
city: Nilüfer
country: Turkey
facility: Bursa Uludağ Üniversitesi
state: Bursa
Study officials:
affiliation: Uludag University
name: Gonca Buran, Asis Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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/s00192-021-04788-w. Epub 2021 Apr 9.
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/nau.23308. Epub 2017 May 23.