Pilates and the Pelvic Floor: A Quasi-experimental Study
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|ClinicalTrials.gov Identifier: NCT04431102|
Recruitment Status : Completed
First Posted : June 16, 2020
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Perineum; Injury Pilates Method Episiotomy Wound||Other: PILATES METHOD||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Single (Outcomes Assessor)|
|Official Title:||The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study|
|Actual Study Start Date :||November 5, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||December 27, 2019|
Experimental: PILATES METHOD
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.
Other: PILATES METHOD
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.
No Intervention: MATERNAL EDUCATION
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.
- Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program [ Time Frame: Between the eighth and tenth day after birth ]Decrease in the number of episiotomies and perineal tears
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431102
|Carmen Feria Ramírez|
|Lepe, Huelva, Spain, 21440|
|Principal Investigator:||Carmen Feria-Ramírez, CNM||University of Huelva|