Physical Therapy in Pregnant Women With Preeclampsia (FPE)
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| First Received Date ICMJE | June 25, 2012 | ||||||||
| Last Updated Date | June 27, 2012 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01630772 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physical Therapy in Pregnant Women With Preeclampsia | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Preeclampsia | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | February 2013 | ||||||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Female | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01630772 | ||||||||
| Other Study ID Numbers ICMJE | 6500, 65002010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Tawana Vicente Bertagnolli, University of Sao Paulo | ||||||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of Sao Paulo | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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