Pre-Pregnancy Counseling for Preconception Health

Overseen By Madison Haiman, MSW

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Morehouse School of Medicine

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

700 Participants Needed

Trial Summary

What is the purpose of this trial?

With support from the National Heart, Lung, and Blood Institute, The Center for Maternal Health Equity at Morehouse School of Medicine is conducting a research study to test the implementation of Pre-Pregnancy Counseling in community-based settings.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the SBIRT treatment for pre-pregnancy counseling?

Research shows that SBIRT, when used during pregnancy, helps identify women at risk of alcohol consumption and reduces the likelihood of continued drinking, which is crucial for maternal and child health. Additionally, preconception counseling, which includes similar interventions, is associated with positive maternal behaviors like quitting drinking before pregnancy, suggesting the potential effectiveness of SBIRT in pre-pregnancy settings. ^{1 2 3 4 5}

Is the SBIRT intervention generally safe for use in humans?

The SBIRT intervention, which includes screening, brief intervention, and referral to treatment, is recommended by major health organizations for use during pregnancy and has been implemented in prenatal care settings. It is considered safe and is used to help reduce alcohol consumption, which can be harmful during pregnancy. ^{1 5 6 7 8}

How does pre-pregnancy counseling differ from other treatments for preconception health?

Pre-pregnancy counseling is unique because it focuses on preventive care before conception, addressing risk factors and promoting healthy behaviors to improve outcomes for both mother and baby. Unlike treatments that begin during pregnancy, this approach includes risk assessment, health promotion, and interventions like folic acid supplementation and lifestyle changes, which can prevent issues before they arise. ^{2 9 10 11 12}

Research Team

Natalie D. Hernandez, PhD

Principal Investigator

Associate Professor

Latrice Rollins, PhD

Principal Investigator

Assistant Professor

Eligibility Criteria

This trial is for Black/African-American individuals who speak English fluently, are not currently pregnant, own a phone, and receive services at the community-based site involved in the study. It aims to improve preconception health.

Inclusion Criteria

Self-identify as Black/African-American

Fluent English-Speaker

Not pregnant at the time of enrollment

Timeline

Exploration

Initial phase to identify and engage with community partners and settings for preconception counseling interventions.

6 months

Preparation

Tailoring of implementation strategy packages and Project IMPACT intervention to the context of 10 sites across 4 states.

6 months

Implementation

Testing of Enhanced vs. Standard implementation strategy package of structured follow-up on pre-conception counseling visits.

6 months

Multiple visits (in-person and virtual)

Sustainment

Co-development of an implementation and sustainment guide for the most effective strategy bundle.

6 months

Follow-up

Participants are monitored for effectiveness and readiness to change for key cardiovascular risk factors.

3.5 years

Surveys at baseline, 3 and 6 months

Treatment Details

Interventions

• SBIRT Intervention

Trial Overview The study tests how well Pre-Pregnancy Counseling can be implemented in community settings to enhance maternal health before conception using an intervention known as SBIRT (Screening, Brief Intervention, and Referral to Treatment).

Participant Groups

Group I: Standard Structured Follow-Up Experimental Treatment 1 Intervention

Mailed informational flyer(s) on prioritized cardiovascular risks

Group II: Enhanced Structured Follow-Up Experimental Treatment 1 Intervention

text or phone message(s) focused on the same prioritized risks + mailed informational flyer(s). These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials

22

Recruited

16,300+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Implementing Screening, Brief Intervention, and Referral to Treatment (SBIRT) for pregnant women is crucial to identify those at risk of alcohol consumption, which can harm both maternal and child health.

The study proposes new performance measures to track the screening and intervention rates for alcohol use in prenatal care, aiming to improve the implementation of SBIRT and support pregnant women in reducing alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance measurement: a proposal to increase use of SBIRT and decrease alcohol consumption during pregnancy. O'Brien, PL.[2021]

The implementation of the SBIRT (Screening, Brief Intervention, and Referral to Treatment) tool into electronic health records (EHR) at three prenatal clinics showed varying performance rates, with the generalist practice achieving an 85% screening rate, indicating effective integration into prenatal care.

Out of 2,619 encounters, only 5.1% of women in the resident clinic reported substance use, highlighting the importance of universal screening in identifying and addressing substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Screening, Brief Intervention and Referral to Treatment (SBIRT) for Substance Use into Prenatal Care. Hostage, JC., Brock, J., Craig, W., et al.[2022]

A new bilingual computerized Screening and Brief Intervention (SBI) program for alcohol and sugar-sweetened beverage use was tested with 290 pregnant women, showing high feasibility and acceptability, with 87% completing the program.

The program identified prenatal alcohol use in 21% of participants, significantly higher than the 13% identified through traditional in-person screening, indicating its effectiveness in detecting alcohol use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy. Nayak, MB., Korcha, RA., Kaskutas, LA., et al.[2019]

Interventions by obstetric caregivers, such as brief interventions and motivational interviewing, have been shown to effectively reduce alcohol consumption among women, even those who drink heavily, before, during, and after pregnancy.

Implementing a stepped-care approach allows healthcare providers to deliver these interventions efficiently, helping to prevent drinking during pregnancy while managing costs and clinic resources effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interventions in prenatal clinics. Handmaker, NS., Wilbourne, P.[2023]

Women at higher risk for complications during pregnancy, such as older age or a history of pregnancy loss, can significantly benefit from preconception counseling to minimize risks to both mother and baby.

Preconception counseling helps inform these women about potential risks and available options, which can only be effectively utilized if discussed before conception, highlighting the physician's role in facilitating this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconceptional counseling. Taysi, K.[2007]

References

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

Performance measurement: a proposal to increase use of SBIRT and decrease alcohol consumption during pregnancy. [2021]

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

Associations between preconception counseling and maternal behaviors before and during pregnancy. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Starting the conversation: Patient initiation of weight-related behavioral counseling during pregnancy. [2023]

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

Evidence-based preconceptional lifestyle interventions. [2022]

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

Integrating Screening, Brief Intervention and Referral to Treatment (SBIRT) for Substance Use into Prenatal Care. [2022]

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

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy. [2019]

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

Missed Opportunities: Screening and Brief Intervention for Risky Alcohol Use in Women's Health Settings. [2018]

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

Motivational interventions in prenatal clinics. [2023]

9. Israel pubmed.ncbi.nlm.nih.gov

[Preconception counseling--for all]. [2006]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Preconception health care interventions: A scoping review. [2018]

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

Preconceptional health promotion: a health education opportunity for all women. [2009]

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

Preconceptional counseling. [2007]