Telehealth Multi-Component Optional Model (MOM) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telehealth MOM, Enhanced Standard of Care.
- Who it may be relevant to
- Registry conditions: Maternal Health. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
Overview
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.
Interventions
- Behavioral Telehealth 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. - Other Enhanced 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.
Primary outcome measures
- Completion of post-partum 6-week comprehensive visit [Time frame: Baseline to 6 weeks post-partum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 6 centers
- UAMS El Dorado FMC — El Dorado
- UAMS Fayetteville FMC — Fayetteville
- UAMS Fort Smith FMC — Fort Smith
- UAMS Jonesboro FMC — Jonesboro
- UAMS Health Women's Center — Little Rock
- UAMS Springdale FMC — Springdale
Identifiers
NCT: NCT06095960 · 276311