Skip to content

Pedometers for the Enhancement of Post Cesarean Mobility

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03724760
Enrollment
291
Registered
2018-10-30
Start date
2018-12-03
Completion date
2019-07-30
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mobility Limitation

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.

Interventions

OTHERpersonalized repeated feedback approach

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

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of steps48 hoursNumber of steps taken by patient as recirded by pedometer

Secondary

MeasureTime frameDescription
Number of participants with a postpartum complication composite48 hoursComposite of postpartum complications, including infectious (endometritis, wound), blood product transfusion
Number of analgesic doses48 hoursNumber of doses of analgesics consumed by patient
Length of hospitalizationFrom 72 hours to one weekDuration of postpartum hospitalization
Number of thromboembolic eventsSix weeksThromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026