Pedometers for the Enhancement of Post Cesarean Mobility

Not Applicable

Completed

• Conditions: Mobility Limitation
• Interventions: Other: personalized repeated feedback approach

• Registration Number: NCT03724760
• Lead Sponsor: Wolfson Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Study Start: 2018-12-03
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-03
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 291

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feedback	personalized repeated feedback approach	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.

Primary Outcome Measures

Name	Time	Method
Number of steps	48 hours	Number of steps taken by patient as recirded by pedometer

Secondary Outcome Measures

Name	Time	Method
Number of participants with a postpartum complication composite	48 hours	Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion
Number of analgesic doses	48 hours	Number of doses of analgesics consumed by patient
Length of hospitalization	From 72 hours to one week	Duration of postpartum hospitalization
Number of thromboembolic events	Six weeks	Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel