NCT01020240

Brief Summary

The purpose of this study is to promote a prevention of the complications using an elaborate guide effective and easy to understand.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

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

March 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

2 months

First QC Date

November 24, 2009

Last Update Submit

November 25, 2009

Conditions

Postpartum Period

Keywords

Immediate puerperiumphysiotherapy in postpartumcesarean complications

Outcome Measures

Primary Outcomes (1)

  • Analogic Visual Scale

    6 months

Secondary Outcomes (1)

  • Analogic Visual Scale

    6 months

Study Arms (3)

Avaliation

NO INTERVENTION

This group will have 15 women in puerperium and will be realize an interview to avalide the cesarean discomforts in immediate puerperium. These dates will be use for elaborate the orientations guide.

Behavioral: Avolition

Orientation

NO INTERVENTION

In this group will be realize an interview to avalide the cesarean discomforts in immediate puerperium or in the first post operatory and in the second post operatory wil be realize a new interview.

Behavioral: Orientation

Guide

EXPERIMENTAL

in This group wiil be realize an interview to avalide the cesarean discomforts in immediate puerperium or in the first post operatory, will be realize the orientations and the guide will be give, and in the second post operatory will be realize a new interview.

Behavioral: Guide

Interventions

AvolitionBEHAVIORAL

\- avolition for cesarean discomforts

Avaliation
OrientationBEHAVIORAL

* avolition of cesarean discomfort * physiotherapy orientation

Orientation
GuideBEHAVIORAL

* avolition of cesarean discomfort * physiotherapy orientation * guide orientation

Guide

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • have between 15 and 35 yeas old
  • has realize an emergency or elective cesarean
  • being in immediate puerperium and did not have receive any orientation

You may not qualify if:

  • complications in delivery and postpartum
  • complications with the baby
  • physicologics disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sepaco Hospital

São Paulo, São Paulo, 04102-900, Brazil

Location

Study Officials

  • Patricia Batista

    São Marcos University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

BR(1)