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Pilates and the Pelvic Floor: A Quasi-experimental Study

Primary Purpose

Pregnancy, Perineum; Injury, Pilates Method

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PILATES METHOD
Sponsored by
University of Huelva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Nursing, Midwifery, Nurse, Pilates Method, Pelvic floor, Injuries, Episiotomy, Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • To go to the Maternal Education program.
  • Give your written consent to participate in the study.
  • Singleton pregnancy.
  • Low-risk pregnancy.
  • No contraindication to physical exercise.
  • Age equals or more than 18 years old.

Excusion Criteria:

  • Pregnant women with poor pregnancy control.
  • Difficulty in speaking or understanding Spanish.
  • Required a C-section during delivery.
  • Refusal to participate in the study.

Sites / Locations

  • Carmen Feria Ramírez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PILATES METHOD

MATERNAL EDUCATION

Arm Description

It was intended the Pilates program were low supervision and easily realizable by all patients, which implied flexibility in the schedule. In this sense the sessions of Pilates was adjusted to these assumptions and the Pilates monitor offered several schedules on diferent days of the week. The pregnant women assigned to the intervention group were supervised by the midwifery of reference and trained by a Pilates monitor who explained the training program. The women received eight sessions of Pilates, given with a frequency of two classes per week and one hour of duration during a period of four weeks. The exercises for each session were determined beforehand. In addition, the participants maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. The therapeutic control were carried out by telephone call and clinical history review between the eighth and tenth day postpartum.

The control group maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. Therapeutic control was carried out by phone call and review of the clinical history between the eighth and tenth day postpartum.

Outcomes

Primary Outcome Measures

Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Decrease in the number of episiotomies and perineal tears

Secondary Outcome Measures

Full Information

First Posted
June 10, 2020
Last Updated
June 15, 2020
Sponsor
University of Huelva
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1. Study Identification

Unique Protocol Identification Number
NCT04431102
Brief Title
Pilates and the Pelvic Floor: A Quasi-experimental Study
Official Title
The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Huelva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.
Detailed Description
It is postulated that in pregnang women, the practice of PM can reduce the severity of birth injuries. Our main objective was to determine the effectiveness of a PM program to reduce the incidence and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD. Secondary objectives were: Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the effect of a MP program on body weight (BMI). It is a parallel group clinical trial with an allocation ratio of 1:2. All pregnant women will be informed about the nature of the clinical trial. There will be no differences in the pregnant´s follow-up because it will be performed by two same Pilates monitor with the same formation. Once the pregnant women is assigned to an arm of the study, those assigned to the intervention group will be sent to the Pilates monitor to explain and initiate the exercise of MP program while the control group will be informed to maintain their usual monitoring of pregnancy. In the initial visit, the type of physical activity will be evaluated by filling in the international physical activity questionnaire (IPAQ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Perineum; Injury, Pilates Method, Episiotomy Wound
Keywords
Nursing, Midwifery, Nurse, Pilates Method, Pelvic floor, Injuries, Episiotomy, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The professionals who assessed the progress of labor in the delivery room and completed the medical history did not know whether the woman belonged to the intervention or the control group.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PILATES METHOD
Arm Type
Experimental
Arm Description
It was intended the Pilates program were low supervision and easily realizable by all patients, which implied flexibility in the schedule. In this sense the sessions of Pilates was adjusted to these assumptions and the Pilates monitor offered several schedules on diferent days of the week. The pregnant women assigned to the intervention group were supervised by the midwifery of reference and trained by a Pilates monitor who explained the training program. The women received eight sessions of Pilates, given with a frequency of two classes per week and one hour of duration during a period of four weeks. The exercises for each session were determined beforehand. In addition, the participants maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. The therapeutic control were carried out by telephone call and clinical history review between the eighth and tenth day postpartum.
Arm Title
MATERNAL EDUCATION
Arm Type
No Intervention
Arm Description
The control group maintained the usual monitoring of pregnancy valued by the reference average, attending the sessions of the maternal education program of their health center. Therapeutic control was carried out by phone call and review of the clinical history between the eighth and tenth day postpartum.
Intervention Type
Other
Intervention Name(s)
PILATES METHOD
Intervention Description
It is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week. The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women. The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day.
Primary Outcome Measure Information:
Title
Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
Description
Decrease in the number of episiotomies and perineal tears
Time Frame
Between the eighth and tenth day after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To go to the Maternal Education program. Give your written consent to participate in the study. Singleton pregnancy. Low-risk pregnancy. No contraindication to physical exercise. Age equals or more than 18 years old. Excusion Criteria: Pregnant women with poor pregnancy control. Difficulty in speaking or understanding Spanish. Required a C-section during delivery. Refusal to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Feria-Ramírez, CNM
Organizational Affiliation
University of Huelva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmen Feria Ramírez
City
Lepe
State/Province
Huelva
ZIP/Postal Code
21440
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual data will be available after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.
IPD Sharing Time Frame
The data will be available after the end of the study until one year the article publication.
IPD Sharing Access Criteria
To obtain the data, a proposal must be sent to Carmen.feria@denf.uhu.es. To gain access, data requestors will need to sign a data access agreement.
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Links:
URL
https://www.juntadeandalucia.es/export/drupaljda/salud_5af1956fa966b_embarazo_parto_puerperio_septiembre_2014.pdf
Description
Proceso Asistencia Integrado embarazo, parto y puerperio

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Pilates and the Pelvic Floor: A Quasi-experimental Study

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