Physical Therapy in Pregnant Women With Preeclampsia (FPE)

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

Tracking Information

• First Submitted Date: June 25, 2012
• First Posted Date: June 28, 2012
• Last Update Posted Date: June 28, 2012
• Study Start Date: June 2012
• Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Physical Therapy in Pregnant Women With Preeclampsia
• Official Title: Influence of a Physical Therapy Protocol in Maternal and Fetal Hemodynamics in Pregnant Women With Preeclampsia
• 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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Single (Investigator); Primary Purpose: Basic Science
• Condition: Preeclampsia

Intervention

• 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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 27, 2012): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2013
• Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01630772
• Other Study ID Numbers: 6500; 65002010 ( Other Identifier: Approval of the ethics committee )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tawana Vicente Bertagnolli, University of Sao Paulo
• Study Sponsor: University of Sao Paulo
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Sao Paulo
• Verification Date: June 2012