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 — BEHAVIORAL
    Motivational 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 — BEHAVIORAL
    No 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 Intervention
    Patients 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 care
    No motivational interviewing or text messages will be provided.

Primary Outcome Measure

Incidence of maternal anemia [ Time Frame: At delivery ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
McCampbell HallColumbusOhio43210
William Grobman, MD, MBA
614-293-4929
Anna Bartholomew, BSN, RN, MPH
614-685-3229
The Ohio State University Outpatient Care EastColumbusOhio43203
William Grobman, MD, MBA
(614) 293-4929
Anna Bartholomew, BSN, RN, MPH
614-685-3229
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
William Grobman, MD, MBA
(614) 293-4929
Anna Bartholomew, BSN, RN, MPH
614-685-3229

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