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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights
EleVATE GC Trial 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.Check my eligibility
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.See study design
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.
EleVATE GC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28-40 week visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28-40 week visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perinatal Depression
Secondary outcome measures
Anxiety
Maternal Attachment (Antenatal)
Maternal Attachment (Postnatal)
+6 moreEleVATE GC 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
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,483 Total Patients Enrolled
6 Trials studying Postpartum Depression
2,471 Patients Enrolled for Postpartum Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are carrying more than one baby at the same time.I am less than 18 weeks pregnant.The fetus is considered to be a fetus at ≤16 weeks' gestationI speak English or Spanish.I have a serious health condition that requires more care than a group can provide.The fetus has a significant abnormality.I have a serious health or mental condition that requires more care than a group can offer.You have one or more factors that increase your chances of getting depressed after giving birth. These factors include having a personal or family history of depression, being a teenager, being single, having a low income, experiencing physical or sexual abuse, having an unplanned or unwanted pregnancy, or experiencing pregnancy loss.I can attend group prenatal visits on specific days and times.You are okay with being randomly assigned to a treatment group.
Research Study Groups:
This trial has the following groups:- Group 1: Group Prenatal Care
- Group 2: Individual Prenatal Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients able to participate in this current experiment?
"According to clinicaltrials.gov, this medical trial is not currently accepting new patients; the initial posting was made on May 21st 2021 and the last update occurred November 22nd 2022. However, there are 1,411 other studies that still require volunteers at present."
Answered by AI
Who else is applying?
What state do they live in?
Kansas
How old are they?
18 - 65
What site did they apply to?
University of Missouri-Kansas City/Truman Health Centers-Kansas City
What portion of applicants met pre-screening criteria?
Met criteria
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