Better Birth Outcomes Through Technology, Education, and Reporting (BETTER)

Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Pre-Term Birth; Maternal Anemia; Hypertensive Disorders
• Intervention / Treatment: Behavioral: BETTER: motivational interviewing and text messaging; Behavioral: Standard of care

Detailed Description

There are more than 3.5 million births per year in the United States. A substantial portion of these births (approximately 25-30%) occur in the context of significant adverse pregnancy outcomes (APOs) including preterm birth (PTB), hypertensive disorders of pregnancy (HDP), small-for-gestational-age birth (SGA), and intrauterine fetal demise (IUFD). Moreover, these complications significantly increase the risk of both maternal and perinatal morbidity and mortality and are associated with adverse health consequences throughout the life course of both individuals. Anemia in pregnancy has been consistently cited as an important factor in and upstream of APOs such as PTB and HDP, severe maternal morbidity, and maternal mortality, and for disparities in these outcomes as well.

This study will expand our understanding of addressing SDoH, including linkage to services that mitigate SDoH. This information can inform future interventions that address SDoH. Creating new tools to address the needs and strengths of obstetric patients, and encouraging their use, will improve the management of patient care during and after pregnancy.

The patient sample will include obstetric patients receiving care at the OSUWMC McCampbell OB/GYN clinic or the OSUWMC Outpatient Care East OB/GYN clinic. A total of 550 patients will participate in the study and be randomly assigned to either the intervention or control group. We will collect maternal and child health outcome data using patient electronic health records and surveys.

At the time of randomization at the patient's prenatal appointment, a researcher will use a survey to collect participant baseline data, including patient demographics and patient-reported outcomes. This information will be collected again during a study visit during the patient's prenatal appointment when the patient is 28-32 weeks gestation.

Final data collection from patient records will occur after delivery (for both intervention and control groups). Research staff will extract information from patients' and their baby's medical records, including maternal and perinatal outcomes.

The intervention includes one motivational interviewing session that encourages the patient to address their social needs. Following the intervention, patients will receive bi-weekly text messages with links to help them address social needs; these links are: (1) to a patient portal to enable them connect with their care team, (2) to Health Impact Ohio, a local organization that can help patients address social needs; and (3) to "findhelp.org," a site that can provide a list of resources based on zip code.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann McAlearney, ScD, MS; Phone Number: 614-293-3716; Email: Ann.McAlearney@osumc.edu
• Study Contact Backup: Name: Nicole Thomas, PhD; Phone Number: 614-247-6228; Email: Nicole.Thomas3@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • McCampbell Hall
      • Contact: William Grobman, MD, MBA; Phone Number: 614-293-4929; Email: William.Grobman@osumc.edu
      • Contact: Anna Bartholomew, BSN, RN, MPH; Phone Number: 614-685-3229; Email: Anna.Bartholomew@osumc.edu
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
      • Contact: Anna Bartholomew, BSN, RN, MPH; Phone Number: 614-685-3229; Email: Anna.Bartholomew@osumc.edu
      • Contact: William Grobman, MD, MBA; Phone Number: (614) 293-4929; Email: William.Grobman@osumc.edu
    • Columbus, Ohio, United States, 43203
      • Recruiting
      • The Ohio State University Outpatient Care East
      • Contact: Anna Bartholomew, BSN, RN, MPH; Phone Number: 614-685-3229; Email: Anna.Bartholomew@osumc.edu
      • Contact: William Grobman, MD, MBA; Phone Number: (614) 293-4929; Email: William.Grobman@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: BETTER: motivational interviewing and text messaging; 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.
Active Comparator: Standard of care; No motivational interviewing or text messages will be provided.	Behavioral: Standard of care; No motivational interviewing or text messages will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of maternal anemia	Hemoglobin < 11.0 g/dL	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pre-term birth	Delivery prior to 37 weeks of gestation	At delivery
Incidence of Hypertensive disorders of pregnancy	Antepartum gestational hypertension or preeclampsia of any severity through the postpartum	Through study completion, approximately 6 months
Incidence of infection	As determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum	Through study completion, approximately 6 months
Incidence of Cesarean Delivery	Delivery by Cesarean section	At delivery
Incidence of Postpartum hemorrhage	Blood loss >1000cc	Through study completion, approximately 6 months
Incidence Severe maternal morbidity	>3 units of packed red blood cell transfusion or ICU admission	Through study completion, approximately 6 months
Incidence of maternal mortality	Death	Through study completion, approximately 6 months
Incidence of Small for gestational age birth	<10th percentile for gestational age	At birth
Incidence of Large for gestational age	>90th percentile for gestational age	At birth
Incidence of NICU admission	Admission to the NICU	Through study completion, approximately 6 months
Incidence of Perinatal mortality	Intrauterine or neonatal death	Through study completion, approximately 6 months
Incidence of Prenatal care visits	Number of prenatal care visits	From randomization through delivery
Incidence of Antepartum admission	Hospital admission other than for delivery	From randomization through delivery
Length of stay (days)	Length of hospital stay at delivery admission	Immediately after discharge from the delivery hospitalization
Postpartum re-admission	Hospital admission after postpartum discharge	From delivery discharge through 6 weeks post partum

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: William Grobman, MD, MBA, Ohio State University; Principal Investigator: Ann McAlearney, ScD, MS, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Disparities; Patient engagement; Social Determinants of Health (SDoH); Patient portals
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Hypertension
• Other Study ID Numbers: 2023H0065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No