Clinical trial NCT04431102: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Perineum; Injury
Pilates Method
Episiotomy Wound
Keywords: Nursing
Midwifery
Nurse
Pilates Method
Pelvic floor
Injuries
Episiotomy
Pregnancy
Lead sponsor: University of Huelva
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program
timeFrame: Between the eighth and tenth day after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Lepe
country: Spain
facility: Carmen Feria Ramírez
state: Huelva
Study officials:
affiliation: University of Huelva
name: Carmen Feria-Ramírez, CNM
role: PRINCIPAL_INVESTIGATOR
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