Better Birth Outcomes Through Technology, Education, and Reporting

NCT06261398 | Recruiting

• 1 other identifier: 2023H0065
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pregnancy; Maternal Anemia; Pre-Term Birth; Hypertensive Disorders

Keywords

Social Determinants of Health (SDoH); Pregnancy; Patient portals; Patient engagement; Disparities

Outcome Measures

Primary Outcomes (1)

• Incidence of maternal anemia

  Hemoglobin \< 11.0 g/dL

  At delivery

Secondary Outcomes (15)

• Incidence of Pre-term birth

  At delivery

• Incidence of Hypertensive disorders of pregnancy

  Through study completion, approximately 6 months

• Incidence of infection

  Through study completion, approximately 6 months

• Incidence of Cesarean Delivery

  At delivery

• Incidence of Postpartum hemorrhage

  Through study completion, approximately 6 months

Study Arms (2)

BETTER Intervention

EXPERIMENTAL

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.

Behavioral: BETTER: motivational interviewing and text messaging

Standard of care

ACTIVE COMPARATOR

No motivational interviewing or text messages will be provided.

Behavioral: Standard of care

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.

BETTER Intervention

Standard of care BEHAVIORAL

No motivational interviewing or text messages will be provided.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is restricted to pregnant individuals.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Less than 20 weeks and 6 days pregnant upon enrollment
• At least 18 years of age
• Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East
• Singleton pregnancy and fetus with a heartbeat
• English speaking
• Able to receive text messages

You may not qualify if:

• Has a significant medical condition (eg sickle cell disease) that is a cause of anemia
• Has a plan for transfusion during pregnancy

Sponsors & Collaborators

• Ohio State University: lead
• American Heart Association: collaborator

Study Sites (3)

The Ohio State University Outpatient Care East

Columbus, Ohio, 43203, United States

RECRUITING

McCampbell Hall

Columbus, Ohio, 43210, United States

RECRUITING

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• McAlearney AS, MacEwan SR, Huerta TR, Thomas NR, Sova LN, Roth L, Bartholomew A, Rush LJ, Johnson KF, Grobman WA. Patient-informed outpatient intervention to improve pregnancy outcomes through connections to social services: protocol for the BETTER randomised controlled trial. BMJ Open. 2025 Jun 18;15(6):e096119. doi: 10.1136/bmjopen-2024-096119.

  PMID: 40533225 DERIVED

MeSH Terms

Conditions

Patient Participation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William Grobman, MD, MBA

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Ann McAlearney, ScD, MS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann McAlearney, ScD, MS

CONTACT

614-293-3716; Ann.McAlearney@osumc.edu

Nicole Thomas, PhD

CONTACT

614-247-6228; Nicole.Thomas3@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Family Medicine and Executive Director, CATALYST

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 15, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)