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NCT Number: NCT06095960

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.

Recruiting

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Key information

Conditions

Maternal Health

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UAMS El Dorado FMC, El Dorado, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Telehealth MOM

Behavioral

Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.

Enhanced Standard of Care

Other

Patients will receive enhanced standard of care which includes: education on symptoms and when to call their healthcare provider, comprehensive 6-week post-partum visit, and any healthcare deemed necessary by providers.

Primary outcomes

  1. Completion of post-partum 6-week comprehensive visit

    Time frame: Baseline to 6 weeks post-partum

    Binary measure (yes/no) of visit completion

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Rowland, MA

CONTACT

[email protected]

4797138661

Kacie Simpson, BS

CONTACT

[email protected]

4797138661

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Feb 5, 2026

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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