Better Birth Outcomes Through Technology, Education, and Reporting

Pregnancy Clinical Trial

— BETTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261398
• Other study ID #: 2023H0065
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Ann McAlearney, ScD, MS
• Phone: 614-293-3716
• Email: Ann.McAlearney[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: March 2028
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-Term Birth
• Pregnancy
• Premature Birth

Intervention

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.
• Standard of care
No motivational interviewing or text messages will be provided.

Locations

Country	Name	City	State
United States	McCampbell Hall	Columbus	Ohio
United States	The Ohio State University Outpatient Care East	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of maternal anemia		From randomization to admission for delivery
Secondary	Incidence of Pre-term birth	Delivery prior to 37 weeks of gestation	At delivery
Secondary	Incidence of Hypertensive disorders of pregnancy	Antepartum gestational hypertension or preeclampsia of any severity through the postpartum	Through study completion, approximately 6 months
Secondary	Incidence of infection	As determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum	Through study completion, approximately 6 months
Secondary	Incidence of Cesarean Delivery	Delivery by Cesarean section	At delivery
Secondary	Incidence of Postpartum hemorrhage	Blood loss >1000cc	Through study completion, approximately 6 months
Secondary	Incidence Severe maternal morbidity	>3 units of packed red blood cell transfusion or ICU admission	Through study completion, approximately 6 months
Secondary	Incidence of maternal mortality	Death	Through study completion, approximately 6 months
Secondary	Incidence of Small for gestational age birth	<10th percentile for gestational age	At birth
Secondary	Incidence of Large for gestational age	>90th percentile for gestational age	At birth
Secondary	Incidence of NICU admission	Admission to the NICU	Through study completion, approximately 6 months
Secondary	Incidence of Perinatal mortality	Intrauterine or neonatal death	Through study completion, approximately 6 months
Secondary	Incidence of Prenatal care visits	Number of prenatal care visits	From randomization through delivery
Secondary	Incidence of Antepartum admission	Hospital admission other than for delivery	From randomization through delivery
Secondary	Length of stay (days)	Length of hospital stay at delivery admission	Immediately after discharge from the delivery hospitalization
Secondary	Postpartum re-admission	Hospital admission after postpartum discharge	From delivery discharge through 6 weeks post partum