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Pre-Pregnancy Counseling for Preconception Health

Phase 2

Waitlist Available

Led By Natalie D. Hernandez, PhD

Research Sponsored by Morehouse School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

Study Summary

This trial is studying ways to help women plan healthy pregnancies and reduce health disparities. #PrePregnancyCounseling

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Since this trial involves counseling rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience emotional or psychological responses to discussions about health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effectiveness

Implementation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard Structured Follow-UpExperimental Treatment1 Intervention

Mailed informational flyer(s) on prioritized cardiovascular risks

Group II: Enhanced Structured Follow-UpExperimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,305,796 Total Patients Enrolled

Morehouse School of MedicineLead Sponsor

20 Previous Clinical Trials

15,451 Total Patients Enrolled

Natalie D. Hernandez, PhDPrincipal InvestigatorAssociate Professor

Media Library

Standard Structured Follow-Up Clinical Trial Eligibility Overview. Trial Name: NCT05987059 — Phase 2

Preconception Health Research Study Groups: Standard Structured Follow-Up, Enhanced Structured Follow-Up

Preconception Health Clinical Trial 2023: Standard Structured Follow-Up Highlights & Side Effects. Trial Name: NCT05987059 — Phase 2

Standard Structured Follow-Up 2023 Treatment Timeline for Medical Study. Trial Name: NCT05987059 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial seek to include individuals aged 55 and over?

"According to the study's inclusion criteria, individuals between 18 and 44 years of age are eligible for enrollment."

Answered by AI

Does the FDA sanction Standard Structured Follow-Up?

"Our internal review at Power has given Standard Structured Follow-Up a safety rating of 2 because this is only on Phase 2 trial. Therefore, there exists evidence supporting the security measures but no data to support its efficacy."

Answered by AI

Am I eligible to take part in this scientific investigation?

"To be elligible for this clinical study, potential participants should possess a pre-existing level of health and range in age from 18 to 44. Approximately 700 individuals are needed to complete the trial."

Answered by AI

Is this experiment still open to new participants?

"Verification from clinicaltrials.gov reveals that this medical trial, posted on August 1st 2023 and last edited two days later, is not currently searching for participants. Yet, fortunately there are other research studies in the vicinity recruiting volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT

2023. "Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987059.