Pilates and the Pelvic Floor: A Quasi-experimental Study

NCT04431102 | Completed DMC

• 1 other identifier: CFMP14
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Perineum; Injury; Pilates Method; Episiotomy Wound

Keywords

Nursing; Midwifery; Nurse; Pilates Method; Pelvic floor; Injuries; Episiotomy; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program

  Decrease in the number of episiotomies and perineal tears

  Between the eighth and tenth day after birth

Study Arms (2)

PILATES METHOD

EXPERIMENTAL

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

MATERNAL EDUCATION

NO INTERVENTION

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.

Interventions

PILATES METHOD OTHER

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.

PILATES METHOD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Huelva: lead

Study Sites (1)

Carmen Feria Ramírez

Lepe, Huelva, 21440, Spain

Location

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Related Links

• Proceso Asistencia Integrado embarazo, parto y puerperio

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Carmen Feria-Ramírez, CNM

  University of Huelva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: November 5, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 27, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the end of the study until one year the article publication.
• 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.

Locations

ES (1)