RECRUITING
I'm interested ...!!
Telehealth Multi-Component Optional Model (MOM) Study
The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.
Conditions:
🦠 Maternal Health
🗓️ Study Start (Actual) 12 February 2024
🗓️ Primary Completion (Estimated) 30 January 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 1500
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 El Dorado, Arkansas, United States
📍 Fayetteville, Arkansas, United States
📍 Fort Smith, Arkansas, United States
📍 Jonesboro, Arkansas, United States
📍 Little Rock, Arkansas, United States
📍 Springdale, Arkansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pregnant women between 16-35 weeks gestation
    • * Age 18-44 years
    • * Ability to speak English, Spanish, or Marshallese
    • * Participants may have either a vaginal birth or cesarean section birth

    Exclusion Criteria:

    • * Type 1 diabetes on an insulin pump followed closely by endocrinology
    • * Uncontrolled Type 2 diabetes
    • * End stage renal disease followed closely by nephrology
    • * ICU admission at any point during pregnancy or delivery hospitalization
    • * Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
    • * Incarceration
    • * Mental disability limiting decision-making capacity
    • * Uncontrolled chronic hypertension
    • * HELLP syndrome during pregnancy
    • * Sickle cell disease
    • * Maternal heart condition or heart disease
    • * Opioid use disorder
    • * Lupus
    • * Thrombophilia or blood clots
    • * Need for blood transfusion during delivery hospitalization
    • * Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
Ages Eligible for Study: 18 Years to 44 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 October 2023
  • First Submitted that Met QC Criteria 17 October 2023
  • First Posted 23 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024
I'm interested ...!!