Physical Therapy in Pregnant Women With Preeclampsia (FPE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
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

June 25, 2012
June 27, 2012
June 2012
January 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01630772 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Physical Therapy in Pregnant Women With Preeclampsia
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Preeclampsia
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2013
January 2013   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: Tawana V Bertagnolli, postgraduate 55-16-39871536 tawanavicente@yahoo.com.br
Contact: Ricardo C Cavalli, doctor 55-16-36022231 rcavalli@fmrp.usp.br
Brazil
 
NCT01630772
6500, 65002010
No
Tawana Vicente Bertagnolli, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP