Telehealth Multi-Component Optional Model (MOM) Study

Last updated: March 17, 2025
Sponsor: University of Arkansas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Women's Health

Pregnancy

Reproductive Health

Treatment

Telehealth MOM

Enhanced Standard of Care

Clinical Study ID

NCT06095960
276311
  • Ages 18-44
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 hysterectomyor 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 deliveryhospitalization, requiring prolonged hospitalization postpartum

Study Design

Total Participants: 1500
Treatment Group(s): 2
Primary Treatment: Telehealth MOM
Phase:
Study Start date:
February 12, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • UAMS El Dorado FMC

    El Dorado, Arkansas 71730
    United States

    Site Not Available

  • UAMS Fayetteville FMC

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • UAMS Fort Smith FMC

    Fort Smith, Arkansas 72901
    United States

    Active - Recruiting

  • UAMS Jonesboro FMC

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • UAMS Health Women's Center

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • UAMS Springdale FMC

    Springdale, Arkansas 72764
    United States

    Active - Recruiting

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