RecruitingNot ApplicableNCT06095960

Telehealth Multi-Component Optional Model (MOM) Study

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

Sponsor

University of Arkansas

Enrollment

1,500 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Maternal Health

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

Sex: FEMALEMin Age: 18 YearsMax Age: 44 Years

Inclusion Criteria4

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 Criteria16

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

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Interventions

BEHAVIORALTelehealth MOM

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

OTHEREnhanced Standard of Care

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.