Clinical trial NCT06261398: Better Birth Outcomes Through Technology, Education, and Reporting
Official title: Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Maternal Anemia
Pre-Term Birth
Hypertensive Disorders
Keywords: Social Determinants of Health (SDoH)
Pregnancy
Patient portals
Patient engagement
Disparities
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-02-15
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of maternal anemia
timeFrame: At delivery
Secondary outcomes:
measure: Incidence of Pre-term birth
timeFrame: At delivery
measure: Incidence of Hypertensive disorders of pregnancy
timeFrame: Through study completion, approximately 6 months
measure: Incidence of infection
timeFrame: Through study completion, approximately 6 months
measure: Incidence of Cesarean Delivery
timeFrame: At delivery
measure: Incidence of Postpartum hemorrhage
timeFrame: Through study completion, approximately 6 months
measure: Incidence Severe maternal morbidity
timeFrame: Through study completion, approximately 6 months
measure: Incidence of maternal mortality
timeFrame: Through study completion, approximately 6 months
measure: Incidence of Small for gestational age birth
timeFrame: At birth
measure: Incidence of Large for gestational age
timeFrame: At birth
measure: Incidence of NICU admission
timeFrame: Through study completion, approximately 6 months
measure: Incidence of Perinatal mortality
timeFrame: Through study completion, approximately 6 months
measure: Incidence of Prenatal care visits
timeFrame: From randomization through delivery
measure: Incidence of Antepartum admission
timeFrame: From randomization through delivery
measure: Length of stay (days)
timeFrame: Immediately after discharge from the delivery hospitalization
measure: Postpartum re-admission
timeFrame: From delivery discharge through 6 weeks post partum
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Outpatient Care East
state: Ohio
city: Columbus
country: United States
facility: McCampbell Hall
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: William Grobman, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Ann McAlearney, ScD, MS
role: PRINCIPAL_INVESTIGATOR
References: