Pedometers for the Enhancement of Post Cesarean Mobility

Wolfson Medical Center291 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

291

Conditions

Mobility Limitation

Interventions

personalized repeated feedback approachOTHER

Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Edith Wolfson Medical Center

Holon, Israel

Outcomes

Primary Outcomes

Number of steps

Number of steps taken by patient as recirded by pedometer

Time frame: 48 hours

Secondary Outcomes

Number of participants with a postpartum complication composite

Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion

Time frame: 48 hours

Number of analgesic doses

Number of doses of analgesics consumed by patient

Time frame: 48 hours

Length of hospitalization

Duration of postpartum hospitalization

Time frame: From 72 hours to one week

Number of thromboembolic events

Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli

Time frame: Six weeks

Data from ClinicalTrials.gov

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