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Physical Therapy in Pregnant Women With Preeclampsia (FPE)

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ClinicalTrials.gov Identifier: NCT01630772
Recruitment Status : Unknown
Verified June 2012 by Tawana Vicente Bertagnolli, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Tawana Vicente Bertagnolli, University of Sao Paulo

Study Description
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Brief Summary:
The aim of this study is to evaluate the influence that has a physical therapy protocol in maternal and fetal hemodynamics in relation to blood pressure, maternal and fetal responses and perinatal outcomes.

Condition or disease Intervention/treatment Phase
Preeclampsia Other: Physical therapy Other: No physical therapy Phase 1 Phase 2

Detailed Description:

The hypertensive disorders in pregnancy affecting 5-8% of pregnant women worldwide, contributing significantly to maternal and fetal complications. Various forms of hypertensive disorders occurring during pregnancy, including preeclampsia and chronic hypertension with superimposed preeclampsia. These two disorders present with high blood pressure and proteinuria, and often lead to the hospitalization of pregnant women.

The objective is to evaluate the effectiveness of a physical therapy protocol used in pregnant women with preeclampsia on blood pressure, maternal-fetal outcomes and perinatal outcomes.

Participants in the study pregnant women with preeclampsia and hypertension with superimposed pre-eclampsia, hospitalized, with no significant complications that may impair the normal course of pregnancy. All pregnant women are monitored through laboratory and clinical data and the fetus monitored by tests that assessed their vitality, in addition, pregnant women in the intervention group performed the proposed physiotherapeutic the study protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Influence of a Physical Therapy Protocol in Maternal and Fetal Hemodynamics in Pregnant Women With Preeclampsia
Study Start Date : June 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Intervention Details:
  • Other: Physical therapy
    Physical therapy in women with preeclampsia during the hospitalization
    Other Names:
    • Physicotherapy
    • Hemodinamic
  • Other: No physical therapy
    Comparison of maternal and fetal hemodynamics in women with preeclampsia who underwent physical therapy and who did not have physical therapy
    Other Names:
    • Physiotherapy
    • Hemodinamic

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participed of The study, high-risk pregnant women with gestational age between 24 and 38 weeks, hospitalized with a diagnosis of preeclampsia or chronic hypertension with superimposed preeclampsia, with no other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal well.

Exclusion Criteria:

  • Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;
  • 24-hour proteinuria above 2 g
  • Laboratory abnormalities (thrombocytopenia, alteration of renal function, elevated liver enzymes, elevated bilirubin);
  • Request the patient to leave the project.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01630772


Contacts
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Contact: Tawana V Bertagnolli, postgraduate 55-16-39871536 tawanavicente@yahoo.com.br
Contact: Ricardo C Cavalli, doctor 55-16-36022231 rcavalli@fmrp.usp.br

Locations
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Brazil
The Hospital Clinics, University of Sao Paulo Recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
More Information
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Responsible Party: Tawana Vicente Bertagnolli, physiotherapist graduate student in biology of reproduction, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01630772    
Other Study ID Numbers: 6500
65002010 ( Other Identifier: Approval of the ethics committee )
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012
Keywords provided by Tawana Vicente Bertagnolli, University of Sao Paulo:
women with preeclampsia
physical therapy
maternal-fetal hemodynamics
perinatal outcomes
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications