Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-02-12
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age 18-44 years
* Ability to speak English, Spanish, or Marshallese
* Participants may have either a vaginal birth or cesarean section birth
Exclusion Criteria
* 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
18 Years
44 Years
FEMALE
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Jennifer Callaghan-Koru, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Pearl McElfish, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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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, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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276311
Identifier Type: -
Identifier Source: org_study_id
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