NCT01630772

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

June 25, 2012

Last Update Submit

June 27, 2012

Conditions

Keywords

women with preeclampsiaphysical therapymaternal-fetal hemodynamicsperinatal outcomes

Interventions

Physical therapy in women with preeclampsia during the hospitalization

Also known as: Physicotherapy, Hemodinamic

Comparison of maternal and fetal hemodynamics in women with preeclampsia who underwent physical therapy and who did not have physical therapy

Also known as: Physiotherapy, Hemodinamic

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;
  • hour proteinuria above 2 g
  • Laboratory abnormalities (thrombocytopenia, alteration of renal function, elevated liver enzymes, elevated bilirubin);
  • Request the patient to leave the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital Clinics, University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Tawana V Bertagnolli, postgraduate

CONTACT

Ricardo C Cavalli, doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist graduate student in biology of reproduction

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations