Better Birth Outcomes Through Technology, Education, and Reporting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BETTER: motivational interviewing and text messaging, Standard of care.
- Who it may be relevant to
- Registry conditions: Pregnancy, Maternal Anemia, Pre-Term Birth, Hypertensive Disorders. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)
Overview
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
- 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. - Behavioral Standard of care
No motivational interviewing or text messages will be provided.
Primary outcome measures
- Incidence of maternal anemia [Time frame: At delivery]
Secondary outcome measures (12)
- Incidence of Pre-term birth [Time frame: At delivery]
- Incidence of Hypertensive disorders of pregnancy [Time frame: Through study completion, approximately 6 months]
- Incidence of infection [Time frame: Through study completion, approximately 6 months]
- Incidence of Cesarean Delivery [Time frame: At delivery]
- Incidence of Postpartum hemorrhage [Time frame: Through study completion, approximately 6 months]
- Incidence Severe maternal morbidity [Time frame: Through study completion, approximately 6 months]
- Incidence of maternal mortality [Time frame: Through study completion, approximately 6 months]
- Incidence of Small for gestational age birth [Time frame: At birth]
- Incidence of Large for gestational age [Time frame: At birth]
- Incidence of NICU admission [Time frame: Through study completion, approximately 6 months]
- Incidence of Perinatal mortality [Time frame: Through study completion, approximately 6 months]
- Incidence of Prenatal care visits [Time frame: From randomization through delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 3 centers
- The Ohio State University Outpatient Care East — Columbus
- McCampbell Hall — Columbus
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus
Publications
- 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
Identifiers
NCT: NCT06261398 · 2023H0065