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Better Birth Outcomes Through Technology, Education, and Reporting

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06261398
Acronym
BETTER
Enrollment
550
Registered
2024-02-15
Start date
2024-02-26
Completion date
2028-03-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

BEHAVIORALBETTER: 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.

BEHAVIORALStandard of care

No motivational interviewing or text messages will be provided.

Sponsors

Ohio State University
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of maternal anemiaAt deliveryHemoglobin \< 11.0 g/dL

Secondary

MeasureTime frameDescription
Incidence of Pre-term birthAt deliveryDelivery prior to 37 weeks of gestation
Incidence of Hypertensive disorders of pregnancyThrough study completion, approximately 6 monthsAntepartum gestational hypertension or preeclampsia of any severity through the postpartum
Incidence of infectionThrough study completion, approximately 6 monthsAs determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum
Incidence of Cesarean DeliveryAt deliveryDelivery by Cesarean section
Incidence of Postpartum hemorrhageThrough study completion, approximately 6 monthsBlood loss \>1000cc
Incidence Severe maternal morbidityThrough study completion, approximately 6 months\>3 units of packed red blood cell transfusion or ICU admission
Incidence of maternal mortalityThrough study completion, approximately 6 monthsDeath
Incidence of Small for gestational age birthAt birth\<10th percentile for gestational age
Incidence of Large for gestational ageAt birth\>90th percentile for gestational age
Incidence of NICU admissionThrough study completion, approximately 6 monthsAdmission to the NICU
Incidence of Perinatal mortalityThrough study completion, approximately 6 monthsIntrauterine or neonatal death
Incidence of Prenatal care visitsFrom randomization through deliveryNumber of prenatal care visits
Incidence of Antepartum admissionFrom randomization through deliveryHospital admission other than for delivery
Length of stay (days)Immediately after discharge from the delivery hospitalizationLength of hospital stay at delivery admission
Postpartum re-admissionFrom delivery discharge through 6 weeks post partumHospital admission after postpartum discharge

Countries

United States

Contacts

CONTACTAnn McAlearney, ScD, MS
Ann.McAlearney@osumc.edu614-293-3716
CONTACTNicole Thomas, PhD
Nicole.Thomas3@osumc.edu614-247-6228
PRINCIPAL_INVESTIGATORWilliam Grobman, MD, MBA

Ohio State University

PRINCIPAL_INVESTIGATORAnn McAlearney, ScD, MS

Ohio State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026