NCT01925508

Brief Summary

The purpose of this study is to verify that the implementation of a protocol physiotherapy musculoskeletal pain and reduces anxiety and improves quality of life in patients hospitalized at the clinic of high-risk pregnancies at the Hospital das Clinicas of Ribeirao Preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed preeclampsia. Where patients will be recruited, answered questionnaires before and after application of physiotherapy protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

July 31, 2013

Last Update Submit

May 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life, anxiety and pain in pre-eclampsia

    6 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population will be recruited in the infirmary of the high-risk pregnancy Hostptal das Clinicas of Ribeirao Preto

You may qualify if:

  • Pregnant women with gestational age between 24 and 38 weeks
  • Hospitalized in the sector of high-risk pregnancy clinic of the Hospital of Ribeirão Preto with diagnosis of preeclampsia and chronic hypertension with superimposed pre-eclampsia
  • With the absence of other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal

You may not qualify if:

  • Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas of Ribeirao Preto

Ribeirão Preto, São Paulo, 14040030, Brazil

Location

Related Publications (1)

  • Kasawara KT, do Nascimento SL, Costa ML, Surita FG, e Silva JL. Exercise and physical activity in the prevention of pre-eclampsia: systematic review. Acta Obstet Gynecol Scand. 2012 Oct;91(10):1147-57. doi: 10.1111/j.1600-0412.2012.01483.x. Epub 2012 Jul 24.

    PMID: 22708966BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michelle R Machado, graduation

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapy

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 19, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations