Better Birth Outcomes Through Technology, Education, and Reporting
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT06261398
- Status
- Recruiting
Conditions
- Hypertensive Disorders
- Maternal Anemia
- Pre-Term Birth
- Pregnancy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BETTER: motivational interviewing and text messaging — BEHAVIORALMotivational interviewing to encourage individuals to address their social needs and engage with text messages that allow individuals to connect to their care team, a local organization that can help them address their social needs, and/or a resource that enables them to find help to address their needs based on their zip code.
- Standard of care — BEHAVIORALNo motivational interviewing or text messages will be provided.
Study Details
This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data.
Key Dates
- Start date
- Feb 26, 2024
- Status verified
- Jun 2026
- Primary completion
- Sep 30, 2027
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 550 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: BETTER InterventionPatients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs.
- Active Comparator: Standard of careNo motivational interviewing or text messages will be provided.
Primary Outcome Measure
Incidence of maternal anemia [ Time Frame: At delivery ]
Central Contacts
- Ann McAlearney, ScD, MS614-293-3716
- Nicole Thomas, PhD614-247-6228
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| McCampbell Hall | Columbus | Ohio | 43210 | |
| The Ohio State University Outpatient Care East | Columbus | Ohio | 43203 | |
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 |
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