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Group Prenatal Care for Depression During Pregnancy (EleVATE GC Trial)

N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Serious medical co-morbidity necessitating more care than can be safely provided in group setting
Serious medical co-morbidity/psychiatric illness necessitating more care than can be safely provided in group setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether the "EleVATE GC" intervention can reduce depression, preterm birth, and low birthweight in African-American women. If it is effective, this model could be used to help improve mental and obstetric health for low-income women of color across the US.

Who is the study for?
This trial is for African-American women who are pregnant, at high risk of postpartum depression, and under 18 weeks' gestation. They must be able to give informed consent, attend group prenatal visits, speak English or Spanish, and have a history that may increase their risk of depression. Women with multiple pregnancies or serious health issues are not eligible.
What is being tested?
The study tests EleVATE Group Care against Individual Prenatal Care to see if it can reduce perinatal depression and improve birth outcomes in low-income African-American women. Participants will either join the group care model or receive standard individual care.
What are the potential side effects?
Since this trial involves different methods of prenatal care rather than medication, there aren't typical side effects like you'd expect from drugs. However, participants might experience varying levels of comfort or stress based on the type of care they receive.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious health condition that requires more care than a group can provide.
Select...
I have a serious health or mental condition that requires more care than a group can offer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perinatal Depression
Secondary study objectives
Anxiety
Maternal Attachment (Antenatal)
Maternal Attachment (Postnatal)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group Prenatal CareExperimental Treatment1 Intervention
Group prenatal care model
Group II: Individual Prenatal CareActive Control1 Intervention
Individual prenatal care

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,997 Previous Clinical Trials
2,298,371 Total Patients Enrolled

Media Library

EleVATE Group Care Clinical Trial Eligibility Overview. Trial Name: NCT04838210 — N/A
Pregnancy Research Study Groups: Group Prenatal Care, Individual Prenatal Care
Pregnancy Clinical Trial 2023: EleVATE Group Care Highlights & Side Effects. Trial Name: NCT04838210 — N/A
EleVATE Group Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838210 — N/A
~48 spots leftby Jun 2025
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