Pedometers for the Enhancement of Post Cesarean Mobility

November 3, 2019 updated by: Hadas Ganer Herman, Wolfson Medical Center

Using Pedometers for the Enhancement of Post Caesarean Mobility in High Risk Patients Using a Personalized Repeated Feedback Approach - a Randomized Controlled Trial

This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Edith Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients following cesarean delivery
  • Consent to participation
  • No medical recommendation for bed rest and limited mobility
  • Meet any of the following criteria for high risk for thromboembolic complications - preeclampsia, chronic disease (reumatic, inflammatory bowel disease), obese, smoker > 10 cigaretts a day, age >35, substantial limb varicose, multiple gestation, multiparity (> deliveries), emergent surgery, thrombophilia.

Exclusion Criteria:

  • Refusal to participate
  • Medical recommendation to limit mobility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feedback
Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve feedback regrding the number of steps taken by them at two time points.
Other: personalized repeated feedback approach
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
No Intervention: Control
Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve no feedback regrding the number of steps taken by them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps
Time Frame: 48 hours
Number of steps taken by patient as recirded by pedometer
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a postpartum complication composite
Time Frame: 48 hours
Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion
48 hours
Number of analgesic doses
Time Frame: 48 hours
Number of doses of analgesics consumed by patient
48 hours
Length of hospitalization
Time Frame: From 72 hours to one week
Duration of postpartum hospitalization
From 72 hours to one week
Number of thromboembolic events
Time Frame: Six weeks
Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: Hadas Ganer Herman, MD, Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 3, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0165-18-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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