Back to resultsPedometers for the Enhancement of Post Cesarean Mobility
Primary Purpose
Mobility Limitation
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
personalized repeated feedback approach
Sponsored by
About this trial
This is an interventional prevention trial for Mobility Limitation
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
Sites / Locations
- Edith Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Feedback
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of steps
Number of steps taken by patient as recirded by pedometer
Secondary Outcome Measures
Number of participants with a postpartum complication composite
Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion
Number of analgesic doses
Number of doses of analgesics consumed by patient
Length of hospitalization
Duration of postpartum hospitalization
Number of thromboembolic events
Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli
Full Information
NCT ID
NCT03724760
First Posted
October 29, 2018
Last Updated
November 3, 2019
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03724760
Brief Title
Pedometers for the Enhancement of Post Cesarean Mobility
Official Title
Using Pedometers for the Enhancement of Post Caesarean Mobility in High Risk Patients Using a Personalized Repeated Feedback Approach - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
personalized repeated feedback approach
Intervention Description
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
Primary Outcome Measure Information:
Title
Number of steps
Description
Number of steps taken by patient as recirded by pedometer
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of participants with a postpartum complication composite
Description
Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion
Time Frame
48 hours
Title
Number of analgesic doses
Description
Number of doses of analgesics consumed by patient
Time Frame
48 hours
Title
Length of hospitalization
Description
Duration of postpartum hospitalization
Time Frame
From 72 hours to one week
Title
Number of thromboembolic events
Description
Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli
Time Frame
Six weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadas Ganer Herman, MD
Organizational Affiliation
Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Wolfson Medical Center
City
Holon
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32459426
Citation
Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.
Results Reference
derived
Learn more about this trial
Pedometers for the Enhancement of Post Cesarean Mobility
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