Health TrialsbyHealthPanel

Better Birth Outcomes Through Technology, Education, and Reporting

ConditionsPregnancyMaternal AnemiaPre-Term BirthHypertensive Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Has a significant medical condition (eg sickle cell disease) that is a cause of anemia

Has a plan for transfusion during pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: BETTER InterventionExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of maternal anemia

Hemoglobin \< 11.0 g/dL

Time frame
At delivery

Secondary outcomes

1

Incidence of Pre-term birth

Delivery prior to 37 weeks of gestation

Time frame
At delivery
2

Incidence of Hypertensive disorders of pregnancy

Antepartum gestational hypertension or preeclampsia of any severity through the postpartum

Time frame
Through study completion, approximately 6 months
3

Incidence of infection

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

Time frame
Through study completion, approximately 6 months
4

Incidence of Cesarean Delivery

Delivery by Cesarean section

Time frame
At delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov
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