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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the BETTER treatment for pregnancy outcomes?

The OPERA trial showed that a multifaceted program can improve obstetric practices and outcomes, suggesting that comprehensive approaches like BETTER could be effective. Additionally, quality improvement initiatives have successfully reduced early elective deliveries, indicating that structured interventions can enhance birth outcomes. ^{1 2 3 4 5}

What makes the BETTER Intervention unique compared to other pregnancy treatments?

The BETTER Intervention is unique because it focuses on improving pregnancy outcomes through the use of technology, education, and reporting, which are not typically emphasized in standard pregnancy care. This approach aims to enhance the quality and safety of childbirth by empowering healthcare providers with better tools and practices, rather than relying solely on medical interventions. ^{1 6 7 8 9}

Research Team

Ann McAlearney, ScD, MS

Principal Investigator

Ohio State University

William Grobman, MD, MBA

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. [2018]

2. Australia 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Regional variation in late preterm births in North Carolina. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Rates of major obstetrical complications vary almost fivefold among US hospitals. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Statewide Quality Improvement Initiative to Reduce Early Elective Deliveries and Improve Birth Registry Accuracy. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Drivers of maternity care in high-income countries: can health systems support woman-centred care? [2017]

7. United States 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Factors influencing perinatal outcomes. [2016]

9. United States 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. [2022]