Pedometers for the Enhancement of Post Cesarean Mobility

NCT03724760 | Completed

• 1 other identifier: 0165-18-WOMC
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobility Limitation

Outcome Measures

Primary Outcomes (1)

• Number of steps

  Number of steps taken by patient as recirded by pedometer

  48 hours

Secondary Outcomes (4)

• Number of participants with a postpartum complication composite

  48 hours

• Number of analgesic doses

  48 hours

• Length of hospitalization

  From 72 hours to one week

• Number of thromboembolic events

  Six weeks

Study Arms (2)

Feedback

EXPERIMENTAL

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.

Other: personalized repeated feedback approach

Control

NO INTERVENTION

Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve no feedback regrding the number of steps taken by them.

Interventions

personalized repeated feedback approach OTHER

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

Feedback

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Refusal to participate
• Medical recommendation to limit mobility

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Edith Wolfson Medical Center

Holon, Israel

Location

Related Publications (1)

• Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.

  PMID: 32459426 DERIVED

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hadas Ganer Herman, MD

  Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 30, 2018
• Study Start: December 3, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)