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NCT Number: NCT03724760

Pedometers for the Enhancement of Post Cesarean Mobility

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.

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Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edith Wolfson Medical Center

Holon, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

personalized repeated feedback approach

Other

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

Primary outcomes

  1. Number of steps

    Time frame: 48 hours

    Number of steps taken by patient as recirded by pedometer

Secondary outcomes

  1. Number of participants with a postpartum complication composite

    Time frame: 48 hours

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

  2. Number of analgesic doses

    Time frame: 48 hours

    Number of doses of analgesics consumed by patient

  3. Length of hospitalization

    Time frame: From 72 hours to one week

    Duration of postpartum hospitalization

  4. Number of thromboembolic events

    Time frame: Six weeks

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

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2018
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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