Pedometers for the Enhancement of Post Cesarean Mobility

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724760
• Other study ID #: 0165-18-WOMC
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: November 2019
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Other:
• personalized repeated feedback approach
Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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