Comparing two postpartum care models using telehealth and standard care
Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
This study tests whether a new telehealth care model for postpartum support works better than standard care for new moms, especially those from diverse backgrounds and rural areas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | University of Arkansas Academic / other |
| Locations | 6 sites (El Dorado, Arkansas and 5 other locations) |
| Trial ID | NCT06095960 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two postpartum care models: the Telehealth Multi-Component Optimal Model (Telehealth MOM) and an enhanced standard of care (ESoC). It employs a randomized control trial design to compare these models among diverse women, focusing on timely identification and treatment of postpartum complications. The study aims to address gaps in postpartum care delivery, particularly for underrepresented racial groups and rural residents. By utilizing telehealth, the study seeks to enhance accessibility and meet the unique needs of participants.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-44 years, between 16-35 weeks gestation, who can communicate in English, Spanish, or Marshallese.
Not a fit: Patients with severe maternal health conditions, such as uncontrolled diabetes or heart disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postpartum care delivery and outcomes for diverse populations.
How similar studies have performed: Other studies have shown promise in using telehealth for maternal health, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
El Dorado, Arkansas and 5 other locations
- UAMS El Dorado FMC — El Dorado, Arkansas, United States (Not_yet_recruiting)
- UAMS Fayetteville FMC — Fayetteville, Arkansas, United States (Recruiting)
- UAMS Fort Smith FMC — Fort Smith, Arkansas, United States (Recruiting)
- UAMS Jonesboro FMC — Jonesboro, Arkansas, United States (Not_yet_recruiting)
- UAMS Health Women's Center — Little Rock, Arkansas, United States (Recruiting)
- UAMS Springdale FMC — Springdale, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Callaghan-Koru, PhD — University of Arkansas
- Study coordinator: Brett Rowland, MA
- Email: mbrowland@uams.edu
- Phone: 4797138661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.