Mobility Limitation Clinical Trial
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
Verified date | November 2019 |
Source | Wolfson Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 291 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Edith Wolfson Medical Center | Holon |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of steps | Number of steps taken by patient as recirded by pedometer | 48 hours | |
Secondary | Number of participants with a postpartum complication composite | Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion | 48 hours | |
Secondary | Number of analgesic doses | Number of doses of analgesics consumed by patient | 48 hours | |
Secondary | Length of hospitalization | Duration of postpartum hospitalization | From 72 hours to one week | |
Secondary | Number of thromboembolic events | Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli | Six weeks |
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