Pedometers for the Enhancement of Post Cesarean Mobility

Study Overview
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Brief Summary
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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.

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

Conditions
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Mobility Limitation

Intervention / Treatment
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* Other: personalized repeated feedback approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback<br>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<br>* Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

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