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NCT Number: NCT06261398

Better Birth Outcomes Through Technology, Education, and Reporting

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McCampbell Hall, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of maternal anemia

    Time frame: At delivery

    Hemoglobin < 11.0 g/dL

Secondary outcomes

  1. Incidence of Pre-term birth

    Time frame: At delivery

    Delivery prior to 37 weeks of gestation

  2. Incidence of Hypertensive disorders of pregnancy

    Time frame: Through study completion, approximately 6 months

    Antepartum gestational hypertension or preeclampsia of any severity through the postpartum

  3. Incidence of infection

    Time frame: Through study completion, approximately 6 months

    As determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum

  4. Incidence of Cesarean Delivery

    Time frame: At delivery

    Delivery by Cesarean section

  5. Incidence of Postpartum hemorrhage

    Time frame: Through study completion, approximately 6 months

    Blood loss >1000cc

  6. Incidence Severe maternal morbidity

    Time frame: Through study completion, approximately 6 months

    >3 units of packed red blood cell transfusion or ICU admission

  7. Incidence of maternal mortality

    Time frame: Through study completion, approximately 6 months

    Death

  8. Incidence of Small for gestational age birth

    Time frame: At birth

    <10th percentile for gestational age

  9. Incidence of Large for gestational age

    Time frame: At birth

    >90th percentile for gestational age

  10. Incidence of NICU admission

    Time frame: Through study completion, approximately 6 months

    Admission to the NICU

  11. Incidence of Perinatal mortality

    Time frame: Through study completion, approximately 6 months

    Intrauterine or neonatal death

  12. Incidence of Prenatal care visits

    Time frame: From randomization through delivery

    Number of prenatal care visits

  13. Incidence of Antepartum admission

    Time frame: From randomization through delivery

    Hospital admission other than for delivery

  14. Length of stay (days)

    Time frame: Immediately after discharge from the delivery hospitalization

    Length of hospital stay at delivery admission

  15. Postpartum re-admission

    Time frame: From delivery discharge through 6 weeks post partum

    Hospital admission after postpartum discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Ann McAlearney, ScD, MS

CONTACT

[email protected]

614-293-3716

Nicole Thomas, PhD

CONTACT

[email protected]

614-247-6228

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: BETTER

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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