<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04431102</url>
  </required_header>
  <id_info>
    <org_study_id>CFMP14</org_study_id>
    <nct_id>NCT04431102</nct_id>
  </id_info>
  <brief_title>Pilates and the Pelvic Floor: A Quasi-experimental Study</brief_title>
  <official_title>The Effects of the Pilates Method on Pelvic Floor Injuries During Pregnancy and Childbirth: A Quasi-experimental Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Huelva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Huelva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified&#xD;
      professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction&#xD;
      (PFD) by decreasing the number of birth injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is postulated that in pregnang women, the practice of PM can reduce the severity of birth&#xD;
      injuries.&#xD;
&#xD;
      Our main objective was to determine the effectiveness of a PM program to reduce the incidence&#xD;
      and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.&#xD;
&#xD;
      Secondary objectives were:&#xD;
&#xD;
      Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the&#xD;
      effect of a MP program on body weight (BMI).&#xD;
&#xD;
      It is a parallel group clinical trial with an allocation ratio of 1:2.&#xD;
&#xD;
      All pregnant women will be informed about the nature of the clinical trial. There will be no&#xD;
      differences in the pregnant´s follow-up because it will be performed by two same Pilates&#xD;
      monitor with the same formation.&#xD;
&#xD;
      Once the pregnant women is assigned to an arm of the study, those assigned to the&#xD;
      intervention group will be sent to the Pilates monitor to explain and initiate the exercise&#xD;
      of MP program while the control group will be informed to maintain their usual monitoring of&#xD;
      pregnancy.&#xD;
&#xD;
      In the initial visit, the type of physical activity will be evaluated by filling in the&#xD;
      international physical activity questionnaire (IPAQ).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">December 27, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program</measure>
    <time_frame>Between the eighth and tenth day after birth</time_frame>
    <description>Decrease in the number of episiotomies and perineal tears</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Pregnancy</condition>
  <condition>Perineum; Injury</condition>
  <condition>Pilates Method</condition>
  <condition>Episiotomy Wound</condition>
  <arm_group>
    <arm_group_label>PILATES METHOD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
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.&#xD;
The therapeutic control were carried out by telephone call and clinical history review between the eighth and tenth day postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MATERNAL EDUCATION</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.&#xD;
Therapeutic control was carried out by phone call and review of the clinical history between the eighth and tenth day postpartum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PILATES METHOD</intervention_name>
    <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.&#xD;
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.&#xD;
The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day.</description>
    <arm_group_label>PILATES METHOD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To go to the Maternal Education program.&#xD;
&#xD;
          -  Give your written consent to participate in the study.&#xD;
&#xD;
          -  Singleton pregnancy.&#xD;
&#xD;
          -  Low-risk pregnancy.&#xD;
&#xD;
          -  No contraindication to physical exercise.&#xD;
&#xD;
          -  Age equals or more than 18 years old.&#xD;
&#xD;
        Excusion Criteria:&#xD;
&#xD;
          -  Pregnant women with poor pregnancy control.&#xD;
&#xD;
          -  Difficulty in speaking or understanding Spanish.&#xD;
&#xD;
          -  Required a C-section during delivery.&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen Feria-Ramírez, CNM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Huelva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carmen Feria Ramírez</name>
      <address>
        <city>Lepe</city>
        <state>Huelva</state>
        <zip>21440</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://www.juntadeandalucia.es/export/drupaljda/salud_5af1956fa966b_embarazo_parto_puerperio_septiembre_2014.pdf</url>
    <description>Proceso Asistencia Integrado embarazo, parto y puerperio</description>
  </link>
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  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Huelva</investigator_affiliation>
    <investigator_full_name>Mª Carmen Feria Ramírez</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Nursing</keyword>
  <keyword>Midwifery</keyword>
  <keyword>Nurse</keyword>
  <keyword>Pilates Method</keyword>
  <keyword>Pelvic floor</keyword>
  <keyword>Injuries</keyword>
  <keyword>Episiotomy</keyword>
  <keyword>Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The data will be available after the end of the study until one year the article publication.</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT04431102/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT04431102/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431102
org study id: CFMP14
nct id: NCT04431102
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Non-Randomized
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.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: 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
description: Decrease in the number of episiotomies and perineal tears
arm group label: PILATES METHOD
arm group type: Experimental
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 group label: MATERNAL EDUCATION
arm group type: No Intervention
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: PILATES METHOD
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.
arm group label: PILATES METHOD
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carmen Feria-Ramírez, CNM
role: Principal Investigator
affiliation: University of Huelva
facility: 
country: Spain
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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responsible party type: Principal Investigator
investigator affiliation: University of Huelva
investigator full name: Mª Carmen Feria Ramírez
investigator title: Principal investigator
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The data will be available after the end of the study until one year the article publication.
ipd 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.
provided document: 
provided document: 