Clinical trial NCT06095960: Telehealth Multi-Component Optional Model (MOM) Study
Official title: Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Health
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-10-23
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Completion of post-partum 6-week comprehensive visit
timeFrame: Baseline to 6 weeks post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: El Dorado
country: United States
facility: UAMS El Dorado FMC
state: Arkansas
city: Fayetteville
country: United States
facility: UAMS Fayetteville FMC
state: Arkansas
city: Fort Smith
country: United States
facility: UAMS Fort Smith FMC
state: Arkansas
city: Jonesboro
country: United States
facility: UAMS Jonesboro FMC
state: Arkansas
city: Little Rock
country: United States
facility: UAMS Health Women's Center
state: Arkansas
city: Springdale
country: United States
facility: UAMS Springdale FMC
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jennifer Callaghan-Koru, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Pearl McElfish, PhD
role: PRINCIPAL_INVESTIGATOR
References: