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Group vs Individual Prenatal Care for Pregnancy Outcomes (EMBRACE Trial)

N/A

Recruiting

Led By Miriam Kuppermann, PhD, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Speak English or Spanish

Between 8 and 20 weeks gestation at enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected from study enrollment to three months postpartum

Awards & highlights

EMBRACE Trial Summary

This trial is testing whether group prenatal care with extra services (like transportation and childcare) is better than individual prenatal care with some extra services. The goal is to see if it leads to fewer premature births, less depression and anxiety, and more satisfaction with prenatal care.

Who is the study for?

The EMBRACE study is for pregnant women eligible for Medi-Cal, within 8-20 weeks of gestation, who speak English or Spanish. It's not suitable for those unable to attend group sessions, planning to change their prenatal care provider, or unable to legally consent.Check my eligibility

What is being tested?

This study compares two types of enhanced prenatal care: 'Glow! Group Prenatal Care' and 'Individual Prenatal Care with CPSP services'. The aim is to determine which method better reduces preterm births and depression while improving patient satisfaction.See study design

What are the potential side effects?

Since this trial involves different methods of receiving prenatal care rather than medication, it does not have typical side effects. However, participants may experience varying levels of comfort and satisfaction with the type of care they receive.

EMBRACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I speak English or Spanish.

Select...

I am between 8 and 20 weeks pregnant.

EMBRACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected from study enrollment to three months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected from study enrollment to three months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected from study enrollment to three months postpartum for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Depressive Symptoms

Perceptions of respectful/disrespectful care

Preterm birth

Secondary outcome measures

Changes in anxiety symptom severity

Gestational age at delivery

Satisfaction with prenatal care

EMBRACE Trial Design

2Treatment groups

Active Control

Group I: Individual Prenatal Care- CPSPActive Control1 Intervention

Individual prenatal care with supplemental services covered by CPSP.

Group II: Glow! Group Prenatal CareActive Control1 Intervention

Group prenatal care with wrap around services.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

California State University, Fresno FoundationOTHER

1 Previous Clinical Trials

500 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,994,348 Total Patients Enrolled

1 Trials studying Prenatal Stress

700 Patients Enrolled for Prenatal Stress

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,234,955 Total Patients Enrolled

Media Library

Glow! Group Prenatal Care Clinical Trial Eligibility Overview. Trial Name: NCT04154423 — N/A

Prenatal Stress Research Study Groups: Individual Prenatal Care- CPSP, Glow! Group Prenatal Care

Prenatal Stress Clinical Trial 2023: Glow! Group Prenatal Care Highlights & Side Effects. Trial Name: NCT04154423 — N/A

Glow! Group Prenatal Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154423 — N/A

Frequently Asked Questions

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

How many participants can the current clinical trial accommodate?

"Affirmative. Clinicaltrials.gov suggests that this clinical trial, which was first posted on November 7th 2019 is currently recruiting participants. To date, 2600 individuals need to be recruited from one centre."

Answered by AI

Is this medical trial currently enrolling new participants?

"Indeed, the information available on clinicaltrials.gov affirms that this trial is in active recruitment mode, having initially been listed on November 7th 2019 and last updated February 22nd 2022."

Answered by AI