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Physical Therapy in Pregnant Women With Preeclampsia (FPE)

This study is currently recruiting participants.
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Tawana Vicente Bertagnolli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01630772
First received: June 25, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Preeclampsia
 Other: Physical therapy
Other: No physical therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Influence of a Physical Therapy Protocol in Maternal and Fetal Hemodynamics in Pregnant Women With Preeclampsia

Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630772

Contacts
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
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

No publications provided

Responsible Party: Tawana Vicente Bertagnolli, physiotherapist graduate student in biology of reproduction, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01630772     History of Changes
Other Study ID Numbers: 6500, 65002010
Study First Received: June 25, 2012
Last Updated: June 27, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
women with preeclampsia
physical therapy
maternal-fetal hemodynamics
perinatal outcomes

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013