Physical Therapy in Pregnant Women With Preeclampsia (FPE)

June 27, 2012 updated by: Tawana Vicente Bertagnolli, University of Sao Paulo

Influence of a Physical Therapy Protocol in Maternal and Fetal Hemodynamics in Pregnant Women With Preeclampsia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14049-900
        • Recruiting
        • The Hospital Clinics, University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6500
  • 65002010 (Other Identifier: Approval of the ethics committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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