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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
MOMSPlacenta Trial 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.Check my eligibility
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.See study design
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.
MOMSPlacenta Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
MOMSPlacenta Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
MOMSPlacenta 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
Find a Location
Who is running the clinical trial?
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,266 Total Patients Enrolled
Brooke Army Medical CenterFED
118 Previous Clinical Trials
26,374 Total Patients Enrolled
University of the Incarnate WordLead Sponsor
17 Previous Clinical Trials
2,429 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: MOMS Intervention
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.
Is enrollment for this study still open?
"As per data hosted on clinicaltrials.gov, this trial is not currently open to new recruitment. This study was first posted in late November 2019 and has been recently updated as of August 29th 2022; nevertheless, there are 9 alternative trials with active enrolment at the present time."
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