PregnancyBETTERNCT06261398
Better Birth Outcomes Through Technology, Education, and Reporting
A study testing BETTER: motivational interviewing and text messaging in people with Pregnancy and Maternal Anemia, run by Ohio State University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Maternal Anemia, Pre-Term Birth
- What is being tested?
- BETTER: motivational interviewing and text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Feb 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has a significant medical condition (eg sickle cell disease) that is a cause of anemia
- Has a plan for transfusion during pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Ohio State University Outpatient Care East
Columbus, Ohio, 43203
William Grobman, MD, MBA, (614) 293-4929, William.Grobman@osumc.edu
Anna Bartholomew, BSN, RN, MPH, 614-685-3229, Anna.Bartholomew@osumc.edu
- Recruiting
McCampbell Hall
Columbus, Ohio, 43210
William Grobman, MD, MBA, 614-293-4929, William.Grobman@osumc.edu
Anna Bartholomew, BSN, RN, MPH, 614-685-3229, Anna.Bartholomew@osumc.edu
- Recruiting
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
William Grobman, MD, MBA, (614) 293-4929, William.Grobman@osumc.edu
Anna Bartholomew, BSN, RN, MPH, 614-685-3229, Anna.Bartholomew@osumc.edu
About this study
Official title: Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)
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.
Read the 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.
- Conditions
- Pregnancy, Maternal Anemia, Pre-Term Birth, Hypertensive Disorders
- Being tested
- BETTER: motivational interviewing and text messaging, Standard of care
- Keywords
- Social Determinants of Health (SDoH), Pregnancy, Patient portals, Patient engagement, Disparities
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETTER: motivational interviewing and text messagingBehavioural
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 careBehavioural
No motivational interviewing or text messages will be provided.
| Study group | Role | What they receive |
|---|---|---|
| BETTER Intervention | Experimental | Patients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs. Receives: Behavioral: BETTER: motivational interviewing and text messaging |
| Standard of care | Active comparator | No motivational interviewing or text messages will be provided. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of maternal anemia
Hemoglobin < 11.0 g/dL
Measured: At delivery
Secondary outcomes (15)
Incidence of Pre-term birth
Delivery prior to 37 weeks of gestation
Measured: At delivery
Incidence of Hypertensive disorders of pregnancy
Antepartum gestational hypertension or preeclampsia of any severity through the postpartum
Measured: Through study completion, approximately 6 months
Incidence of infection
As determined by clinical diagnosis (e.g., chorioamnionitis, endometritis, pyelonephritis); intrapartum and postpartum
Measured: Through study completion, approximately 6 months
Incidence of Cesarean Delivery
Delivery by Cesarean section
Measured: At delivery
Incidence of Postpartum hemorrhage
Blood loss >1000cc
Measured: Through study completion, approximately 6 months
Incidence Severe maternal morbidity
>3 units of packed red blood cell transfusion or ICU admission
Measured: Through study completion, approximately 6 months
Incidence of maternal mortality
Death
Measured: Through study completion, approximately 6 months
Incidence of Small for gestational age birth
<10th percentile for gestational age
Measured: At birth
Incidence of Large for gestational age
>90th percentile for gestational age
Measured: At birth
Incidence of NICU admission
Admission to the NICU
Measured: Through study completion, approximately 6 months
Incidence of Perinatal mortality
Intrauterine or neonatal death
Measured: Through study completion, approximately 6 months
Incidence of Prenatal care visits
Number of prenatal care visits
Measured: From randomization through delivery
Incidence of Antepartum admission
Hospital admission other than for delivery
Measured: From randomization through delivery
Length of stay (days)
Length of hospital stay at delivery admission
Measured: Immediately after discharge from the delivery hospitalization
Postpartum re-admission
Hospital admission after postpartum discharge
Measured: From delivery discharge through 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start26 Feb 2024
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Ann McAlearney, Ohio State University
- Investigators
- William Grobman, MD, MBA, Principal investigator, Ohio State UniversityAnn McAlearney, ScD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261398
- Sponsor's protocol ID
- 2023H0065
- Acronym
- BETTER
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40533225
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Birth Outcomes and Experiences Through Technology, Education, and Reporting (BETTER)
- ClinicalTrials.gov ID
- NCT06261398
- Acronym / sponsor ID
- BETTER / 2023H0065
- Conditions
- Pregnancy, Maternal Anemia, Pre-Term Birth, Hypertensive Disorders
- Keywords
- Social Determinants of Health (SDoH), Pregnancy, Patient portals, Patient engagement, Disparities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BETTER Intervention | Experimental | Behavioral: BETTER: motivational interviewing and text messagingPatients in the intervention group will receive one motivational interviewing session immediately after randomization and biweekly text messages until delivery to encourage them to connect to resources to address their social needs. |
| Standard of care | Active comparator | Behavioral: Standard of careNo motivational interviewing or text messages will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Has a significant medical condition (eg sickle cell disease) that is a cause of anemia
- Has a plan for transfusion during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BETTER: motivational interviewing and text messagingMotivational 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. | Behavioural | BETTER Intervention |
| Standard of careNo motivational interviewing or text messages will be provided. | Behavioural | Standard of care |
Primary outcome
Incidence of maternal anemia
Time frame: At delivery
Hemoglobin < 11.0 g/dL
15 secondary outcomes
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
Incidence of Antepartum admission
Time frame: From randomization through delivery
Length of stay (days)
Time frame: Immediately after discharge from the delivery hospitalization
Postpartum re-admission
Time frame: From delivery discharge through 6 weeks post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 40533225McAlearney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Grobman, MD, MBA principal investigator
Ohio State University
Ann McAlearney, ScD, MS principal investigator
Ohio State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BETTER: motivational interviewing and text messaging in people with Pregnancy and Maternal Anemia, run by Ohio State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann McAlearney, ScD, MS (614-293-3716, Ann.McAlearney@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of maternal anemia (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.