Recruiting

Multi-Component Model

Sponsor:

University of Arkansas

Code:

NCT06095960

Conditions

Maternal Health

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

Telehealth MOM

Enhanced Standard of Care

Study Details

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.

Conditions

Maternal Health

Study ID

NCT06095960

Start date

Feb 12, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Telehealth MOM

Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum.

active comparator: Enhanced Standard of Care

Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers.

Interventions

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.

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 measure

  • Completion of post-partum 6-week comprehensive visit [ Time Frame: Baseline to 6 weeks post-partum ]

Central Contacts and Locations

Central contacts

Brett Rowland, MA

4797138661mbrowland@uams.edu

Kacie Simpson, BS

4797138661klsimpson@uams.edu

Locations

UAMS Fayetteville FMC

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Kenny Halloran

KHalloran@uams.edu

UAMS Fort Smith FMC

Recruiting

Fort Smith, Arkansas, United States, 72901

Contacts

Kenny Halloran

KHalloran@uams.edu

UAMS Health Women's Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Kenny Halloran

KHalloran@uams.edu

UAMS Springdale FMC

Recruiting

Springdale, Arkansas, United States, 72764

Contacts

Kenny Halloran

KHalloran@uams.edu

More Information

Sponsor

University of Arkansas

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-02-05.