Maternal Health
Conditions
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.
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.
Sponsors
University of Arkansas
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of post-partum 6-week comprehensive visit | Baseline to 6 weeks post-partum | Binary measure (yes/no) of visit completion |
Countries
United States
Contacts
CONTACTBrett Rowland, MA
CONTACTKacie Simpson, BS
PRINCIPAL_INVESTIGATORJennifer Callaghan-Koru, PhD
University of Arkansas
PRINCIPAL_INVESTIGATORPearl McElfish, PhD
University of Arkansas
Outcome results
None listed