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Clinical Trials/NCT03724760
NCT03724760
Completed
Not Applicable

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

Wolfson Medical Center1 site in 1 country291 target enrollmentDecember 3, 2018
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ConditionsMobility Limitation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mobility Limitation
Sponsor
Wolfson Medical Center
Enrollment
291
Locations
1
Primary Endpoint
Number of steps
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 3, 2018
End Date
July 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadas Ganer Herman

Principal Investigator

Wolfson Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of steps

Time Frame: 48 hours

Number of steps taken by patient as recirded by pedometer

Secondary Outcomes

  • Number of participants with a postpartum complication composite(48 hours)
  • Number of analgesic doses(48 hours)
  • Length of hospitalization(From 72 hours to one week)
  • Number of thromboembolic events(Six weeks)

Study Sites (1)

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