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Physical Therapy in Pregnant Women With Preeclampsia (FPE)

Primary Purpose

Preeclampsia

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Physical therapy
No physical therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Preeclampsia focused on measuring women with preeclampsia, physical therapy, maternal-fetal hemodynamics, perinatal outcomes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hospital Clinics, University of Sao PauloRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 25, 2012
Last Updated
June 27, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01630772
Brief Title
Physical Therapy in Pregnant Women With Preeclampsia
Acronym
FPE
Official Title
Influence of a Physical Therapy Protocol in Maternal and Fetal Hemodynamics in Pregnant Women With Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
women with preeclampsia, physical therapy, maternal-fetal hemodynamics, perinatal outcomes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
Physicotherapy, Hemodinamic
Intervention Description
Physical therapy in women with preeclampsia during the hospitalization
Intervention Type
Other
Intervention Name(s)
No physical therapy
Other Intervention Name(s)
Physiotherapy, Hemodinamic
Intervention Description
Comparison of maternal and fetal hemodynamics in women with preeclampsia who underwent physical therapy and who did not have physical therapy

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tawana V Bertagnolli, postgraduate
Phone
55-16-39871536
Email
tawanavicente@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo C Cavalli, doctor
Phone
55-16-36022231
Email
rcavalli@fmrp.usp.br
Facility Information:
Facility Name
The Hospital Clinics, University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Physical Therapy in Pregnant Women With Preeclampsia

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