Telehealth Multi-Component Optional Model (MOM) Study

Not Applicable

Recruiting

• Conditions: Maternal Health

• Registration Number: NCT06095960
• Lead Sponsor: University of Arkansas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Study Start: 2024-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-01-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion of post-partum 6-week comprehensive visit	Baseline to 6 weeks post-partum	Binary measure (yes/no) of visit completion

Trial Locations

Locations (6)

UAMS El Dorado FMC; 🇺🇸 El Dorado, Arkansas, United States

UAMS Fayetteville FMC; 🇺🇸 Fayetteville, Arkansas, United States

UAMS Fort Smith FMC; 🇺🇸 Fort Smith, Arkansas, United States

UAMS Jonesboro FMC; 🇺🇸 Jonesboro, Arkansas, United States

UAMS Health Women's Center; 🇺🇸 Little Rock, Arkansas, United States

UAMS Springdale FMC; 🇺🇸 Springdale, Arkansas, United States