BETTER Intervention for Pregnancy Outcomes

(BETTER Trial)

Recruiting at 2 trial locations

Overseen By Nicole Thomas, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Sickle cell disease, Transfusion plan, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve pregnancy outcomes, with a focus on reducing anemia (a condition where the blood lacks enough healthy red blood cells) in expectant mothers. Participants will either receive standard care or join the BETTER intervention (Better Birth Outcomes Through Technology, Education, and Reporting), which includes a motivational interview and bi-weekly text messages to connect them with essential resources like housing or food. It is ideal for those less than 20 weeks pregnant, receiving care at specific Ohio State University facilities, and who can receive text messages. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance pregnancy care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BETTER intervention is safe for pregnancy outcomes?

Research has shown that the BETTER program aims to improve pregnancy outcomes by addressing social needs such as housing, food, and transportation. It employs motivational conversations and regular text messages to connect participants with useful resources.

Specific safety data for the BETTER program from past studies is not available. However, it involves non-invasive methods like talking and texting, which are generally safe. Since this trial does not include medication or physical procedures, the risks are likely low.

Participants typically receive support rather than drugs or treatments that might cause side effects. Therefore, the BETTER program is expected to be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BETTER intervention because it uniquely combines motivational interviewing with biweekly text messaging to support pregnant individuals in addressing their social needs. Unlike the standard care, which typically doesn't include behavioral support, this approach aims to create a supportive network that can positively impact pregnancy outcomes. By encouraging connections to resources through personalized communication, the intervention offers a proactive way to tackle the social determinants of health, which are often overlooked in traditional prenatal care.

What evidence suggests that the BETTER intervention is effective for improving pregnancy outcomes?

Research shows that the BETTER program, which participants in this trial may receive, might improve pregnancy outcomes by addressing social needs such as housing, food, and transportation. This program includes motivational talks and bi-weekly text messages to guide patients to helpful resources. Studies suggest this method can lower barriers that often lead to poor maternal health. Although direct data on this specific program's effectiveness is limited, using technology and education to connect people with resources appears promising for improving birth outcomes. Early signs indicate that better access to social support can help reduce issues like maternal anemia and other pregnancy-related problems. ^{1 4 6 7 8}

Who Is on the Research Team?

Ann McAlearney, ScD, MS

Principal Investigator

Ohio State University

William Grobman, MD, MBA

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals experiencing conditions like premature birth or high blood pressure. Participants should be interested in receiving motivational support and text messages to help manage their pregnancy. Specific details on who can join are not provided, but typically include those facing the mentioned health challenges.

Inclusion Criteria

English speaking

Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East

Singleton pregnancy and fetus with a heartbeat

Exclusion Criteria

Has a plan for transfusion during pregnancy

I have a condition like sickle cell that causes anemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Baseline Data Collection

Participants are randomized into intervention or control groups and baseline data is collected

1 week

1 visit (in-person)

Intervention

Participants in the intervention group receive one motivational interviewing session and bi-weekly text messages until delivery

Until delivery

Follow-up

Final data collection from patient records occurs after delivery, including maternal and perinatal outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BETTER

Trial Overview The BETTER intervention, which combines motivational interviewing with bi-weekly supportive text messages, is being tested against standard obstetrical care to see if it reduces maternal anemia and improves pregnancy outcomes.

How Is the Trial Designed?

Group I: BETTER Intervention Experimental Treatment 1 Intervention

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.

Group II: Standard of care Active Control 1 Intervention

No motivational interviewing or text messages will be provided.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

In high-income countries, medical interventions have significantly reduced maternal and neonatal mortality, but care delivery models vary widely, with some practices potentially being harmful and not evidence-based.

Challenges such as high medical liability costs, human resource shortages, and inequitable access to care persist, particularly affecting disadvantaged populations, highlighting the need for improved quality and woman-centered care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drivers of maternity care in high-income countries: can health systems support woman-centred care? Shaw, D., Guise, JM., Shah, N., et al.[2017]

Research over the past 40 years has significantly improved pregnancy outcomes in developed countries, making childbirth relatively safe for mothers and resulting in healthy infant survival.

In contrast, developing countries face 10- to 100-fold higher risks of stillbirth, neonatal mortality, and maternal mortality due to poorly organized healthcare systems and low health expenditures, highlighting a global disparity in maternal and infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing perinatal outcomes. Goldenberg, RL.[2016]

In a study of 50,981 deliveries in Kenya and Uganda, 91.3% resulted in live births, but 1.6% of those live births died before discharge, highlighting the need for improved neonatal care.

The data revealed that preterm and low birthweight infants were significantly associated with stillbirths and pre-discharge deaths, particularly after cesarean sections, indicating a critical area for enhancing maternal and neonatal healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy outcomes in facility deliveries in Kenya and Uganda: A large cross-sectional analysis of maternity registers illuminating opportunities for mortality prevention. Waiswa, P., Higgins, BV., Mubiri, P., et al.[2020]

A multifaceted intervention program in 95 French maternity units led to a significant reduction in suboptimal care for morbidity cases (7.6% vs. 11.5%) and a decrease in the overall incidence of perinatal morbidity (7.0 vs. 8.1‰).

However, the intervention did not significantly lower the combined rate of suboptimal care for morbidity and mortality cases, indicating that further improvements in mortality outcomes may require longer study durations and additional support structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. Dupont, C., Winer, N., Rabilloud, M., et al.[2018]

The BetterBirth Program, tested in a cluster-randomized controlled trial in Uttar Pradesh, India, aims to improve the use of the World Health Organization Safe Childbirth Checklist (SCC) to enhance the quality of facility-based childbirth care.

Key features of the program include coaching for care providers, a structured implementation pathway, and a cloud-based data collection system, which together foster trust and empower providers to overcome barriers in adopting essential birth practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BetterBirth Program: Pursuing Effective Adoption and Sustained Use of the WHO Safe Childbirth Checklist Through Coaching-Based Implementation in Uttar Pradesh, India. Kara, N., Firestone, R., Kalita, T., et al.[2022]

In a study of 203 patients with preterm contractions, those treated according to clinical practice guidelines (CPG) used fewer tocolytics and steroids, leading to reduced healthcare resource consumption.

Patients in the CPG group had shorter hospital stays and maintained better neonatal birthweights compared to those who deviated from the guidelines, indicating that following CPG does not compromise pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two different treatment regimens in women with preterm contractions who were admitted to a hospital due to a presumptive diagnosis of preterm labor: an observational study. Chalermchockcharoenkit, A., Rattanachaiyanont, M., Kongjeera, A., et al.[2019]

In a study of over 750,000 obstetrical deliveries in the US, it was found that 22.55% of women delivering vaginally at low-performing hospitals experienced major complications, compared to only 10.42% at high-performing hospitals.

For cesarean deliveries, the rate of major complications was nearly five times higher at low-performing hospitals (20.93%) compared to high-performing hospitals (4.37%), highlighting significant disparities in obstetrical care quality across hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of major obstetrical complications vary almost fivefold among US hospitals. Glance, LG., Dick, AW., Glantz, JC., et al.[2019]

A quality improvement initiative in Ohio successfully reduced nonmedically indicated early elective deliveries before 39 weeks of gestation across 97% of participating hospitals, with significant declines in induction rates observed in all groups involved.

The initiative also improved the accuracy of birth registry data, with all participating hospitals showing enhanced data accuracy, indicating that such collaborative models can effectively implement evidence-based practices in obstetric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statewide Quality Improvement Initiative to Reduce Early Elective Deliveries and Improve Birth Registry Accuracy. Kaplan, HC., King, E., White, BE., et al.[2021]

In North Carolina, a study of 884,304 neonates found that 7.5% were late preterm (LPT), with significant regional variation in LPT birth rates that could not be fully explained by sociodemographic or medical factors.

Regions 2 and 6 had the highest adjusted percentages of LPT births, suggesting that differences in medical practices among providers may contribute to this variation, indicating a potential area for policy and quality improvement efforts to reduce LPT births.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional variation in late preterm births in North Carolina. Aliaga, SR., Smith, PB., Price, WA., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06261398?id=NCT06261398&rank=1

Better Birth Outcomes Through Technology, Education ... This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40533225/

Patient-informed outpatient intervention to improve pregnancy ... The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention attempts to account for these barriers by ...

3. medicine.osu.edu medicine.osu.edu/news/ohio-state-researchers-lend-expertise-to-large-pregnancy-and-heart-health-study

Ohio State researchers lend expertise to large pregnancy ... “The goal of BETTER is to provide evidence to achieve a sustainable and scalable approach to use technology, education and reporting to reduce ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/15/6/e096119

protocol for the BETTER randomised controlled trial The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention combines motivational interviewing and recurrent text messages ...

5. p3equatehern.org p3equatehern.org/projects/better-project/

BETTER Project Better birth outcomes and Experiences Through Technology, Education, and Reporting (BETTER); Project Goals: Elucidate best practices to connect pregnant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182209/

Patient-informed outpatient intervention to improve pregnancy ... The Better Birth Outcomes Through Technology, Education and Reporting (BETTER) intervention combines motivational interviewing and recurrent ...

7. wexnermedical.osu.edu wexnermedical.osu.edu/departments/innovations/obgyn/inequities-in-pregnancy-outcomes

Researchers form multisite collaboration to study and ... Creating BETTER health outcomes. Ohio State's project is called Better Birth Outcomes and Experiences Through Technology, Education and Reporting (BETTER).

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0884217522000260

Systematic Review of the Effect of Technology-Mediated ... Technology-mediated education interventions were effective at improving mental health, weight loss, knowledge, and breastfeeding outcomes after birth.