Status:
RECRUITING
Telehealth Multi-Component Optional Model (MOM) Study
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Maternal Health
Eligibility:
FEMALE
18-44 years
Phase:
NA
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 Multicompone...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06095960
Start Date
February 12 2024
End Date
December 31 2027
Last Update
March 20 2025
Active Locations (6)
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1
UAMS El Dorado FMC
El Dorado, Arkansas, United States, 71730
2
UAMS Fayetteville FMC
Fayetteville, Arkansas, United States, 72703
3
UAMS Fort Smith FMC
Fort Smith, Arkansas, United States, 72901
4
UAMS Jonesboro FMC
Jonesboro, Arkansas, United States, 72401