Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence

December 29, 2023 updated by: Gonca Buran, Aydin Adnan Menderes University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bursa
      • Nilüfer, Bursa, Turkey, 16059
        • Bursa Uludağ Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Study group
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
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.
Other Names:
  • Experimental: Study group
No Intervention: Control group
The control group was in the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During assessment at registration
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.
Immediately after at the end of the eight-week prenatal pilates-supported birth preparation training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpaortum period- Post-discharge
Time Frame: Post-discharge - one month after birth
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth Outcomes
Time Frame: After labor in 48 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Gonca Buran, Asis Prof, Uludag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-26/193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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