Better Birth Outcomes Through Technology, Education, and Reporting
- Conditions
- Hypertensive DisordersMaternal AnemiaPregnancyPre-Term Birth
- Interventions
- Behavioral: Standard of care
- Registration Number
- NCT06261398
- Lead Sponsor
- Ohio State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care Standard of care No motivational interviewing or text messages will be provided.
- Primary Outcome Measures
Name Time Method Incidence of maternal anemia At delivery Hemoglobin \< 11.0 g/dL
- Secondary Outcome Measures
Name Time Method Incidence of Cesarean Delivery At delivery Delivery by Cesarean section
Incidence of Small for gestational age birth At birth \<10th percentile for gestational age
Incidence of Large for gestational age At birth \>90th percentile for gestational age
Incidence of Prenatal care visits From randomization through delivery Number of prenatal care visits
Length of stay (days) Immediately after discharge from the delivery hospitalization Length of hospital stay at delivery admission
Incidence of maternal mortality Through study completion, approximately 6 months Death
Incidence of Pre-term birth At delivery Delivery prior to 37 weeks of gestation
Incidence of Hypertensive disorders of pregnancy Through study completion, approximately 6 months Antepartum gestational hypertension or preeclampsia of any severity through the postpartum
Incidence of infection Through study completion, approximately 6 months As determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum
Incidence of Postpartum hemorrhage Through study completion, approximately 6 months Blood loss \>1000cc
Incidence Severe maternal morbidity Through study completion, approximately 6 months \>3 units of packed red blood cell transfusion or ICU admission
Incidence of NICU admission Through study completion, approximately 6 months Admission to the NICU
Incidence of Antepartum admission From randomization through delivery Hospital admission other than for delivery
Postpartum re-admission From delivery discharge through 6 weeks post partum Hospital admission after postpartum discharge
Incidence of Perinatal mortality Through study completion, approximately 6 months Intrauterine or neonatal death
Trial Locations
- Locations (3)
The Ohio State University Outpatient Care East
🇺🇸Columbus, Ohio, United States
McCampbell Hall
🇺🇸Columbus, Ohio, United States
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
🇺🇸Columbus, Ohio, United States