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MOMS Intervention for Prenatal Stress (MOMSPlacenta Trial)

N/A

Recruiting

Led By Karen L Weis, PhD

Research Sponsored by University of the Incarnate Word

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of moms intervention administed

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how maternal anxiety during pregnancy affects the placenta and the outcome of the pregnancy.

Who is the study for?

This trial is for pregnant women who are active duty or DoD beneficiaries, at least 18 years old, receiving prenatal care at SAMMC, and speak English. It aims to understand how anxiety during pregnancy affects the placenta and baby's health.

What is being tested?

The study is examining the MOMS Intervention to see if it can reveal links between maternal anxiety and changes in the placenta. It also looks at how these changes might influence both pregnancy outcomes and infant health.

What are the potential side effects?

Since this trial focuses on observational research rather than a medical intervention, specific side effects related to treatments are not applicable.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of maternal serum and placental tissue collection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of maternal serum and placental tissue collection

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of maternal serum and placental tissue collection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Explore associations between prenatal maternal psychosocial measures of anxiety and depression to histopathology changes in placental tissue with and without the M-O-M-S™ intervention.

Explore associations between prenatal maternal psychosocial measures of anxiety depression with immunological, oxidative stress, and hormonal biomarker changes found in maternal serum with and without the M-O-M-S™ support intervention.

Explore associations between prenatal maternal psychosocial measures of anxiety depression with immunological, oxidative stress, and hormonal biomarker changes found in placental tissue with and without the M-O-M-S™ pregnancy intervention.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MOMS InterventionExperimental Treatment1 Intervention

Women that are currently in the Mentors Offering Maternal Support (M-O-M-S) research program as well as pregnant women entering prenatal care in the first trimester, who are not in the M-O-M-S program may participate in the study. Arms Assigned Interventions Experimental: M-O-M-S Intervention M-O-M-S intervention is 10, 1 hour prenatal mentored support groups No Intervention: Routine Prenatal Care Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines

0 / 1Eligibility criteria met