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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06095960
Other study ID # 276311
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 12, 2024
Est. completion date December 31, 2027

Study information

Verified date March 2024
Source University of Arkansas
Contact Brett Rowland, MA
Phone 4797138661
Email mbrowland@uams.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 31, 2027
Est. primary completion date January 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States UAMS El Dorado FMC El Dorado Arkansas
United States UAMS Fayetteville FMC Fayetteville Arkansas
United States UAMS Fort Smith FMC Fort Smith Arkansas
United States UAMS Jonesboro FMC Jonesboro Arkansas
United States UAMS Health Women's Center Little Rock Arkansas
United States UAMS Springdale FMC Springdale Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion of post-partum 6-week comprehensive visit Binary measure (yes/no) of visit completion Baseline to 6 weeks post-partum
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