550 Participants Needed

BETTER Intervention for Pregnancy Outcomes

(BETTER Trial)

Recruiting at 2 trial locations
AM
NT
Overseen ByNicole Thomas, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.16789

Research Team

AM

Ann McAlearney, ScD, MS

Principal Investigator

Ohio State University

WG

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
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: BETTER InterventionExperimental Treatment1 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 careActive Control1 Intervention
No motivational interviewing or text messages will be provided.

Find a Clinic Near You

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. 8.1โ€ฐ).
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.
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.
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.
Regional variation in late preterm births in North Carolina.Aliaga, SR., Smith, PB., Price, WA., et al.[2021]

References

Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. [2018]
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]
Regional variation in late preterm births in North Carolina. [2021]
Rates of major obstetrical complications vary almost fivefold among US hospitals. [2019]
Statewide Quality Improvement Initiative to Reduce Early Elective Deliveries and Improve Birth Registry Accuracy. [2021]
Drivers of maternity care in high-income countries: can health systems support woman-centred care? [2017]
Pregnancy outcomes in facility deliveries in Kenya and Uganda: A large cross-sectional analysis of maternity registers illuminating opportunities for mortality prevention. [2020]
Factors influencing perinatal outcomes. [2016]
The BetterBirth Program: Pursuing Effective Adoption and Sustained Use of the WHO Safe Childbirth Checklist Through Coaching-Based Implementation in Uttar Pradesh, India. [2022]
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