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Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes

Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes (MOMS Placenta)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04993742
Acronym
MOMSPlacenta
Enrollment
150
Registered
2021-08-06
Start date
2019-11-26
Completion date
2026-12-31
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placental Dysfunction, Prenatal Stress

Keywords

placenta, prenatal, pregnancy, maternal anxiety, prenatal depression, biomarker

Brief summary

Explore the associations of prenatal maternal anxiety to placental histologic findings, and the pro-inflammatory, anti-inflammatory, and immunoregulatory cells found in the placenta and determine the effect of maternal anxiety on the association between placental molecular changes on pregnancy and birth and infant outcomes.

Detailed description

Purpose: Explore the associations of prenatal maternal anxiety to placental histologic findings, and the pro-inflammatory, anti-inflammatory, and immunoregulatory cells found in the placenta and determine the effect of maternal anxiety on the association between placental molecular changes on pregnancy and birth and infant outcomes. Subject Population: Prenatal patients receiving obstetrical care at the Brooke Army Medical Center (BAMC) will be the focused population. Patients must be 18 years or older and planning to deliver at the BAMC. Design: This study is a longitudinal prospective, randomized clinical trial with repeated measures of independent groups to investigate both psychosocial and physiologic data in the early prenatal, maternal intervention (Mentors Offering Maternal Support, M-O-M-S™), to standard prenatal care without the M-O-M-S, for decreasing maternal prenatal anxiety and depression, and reducing maternal inflammatory and oxidative stress responses. Procedures: Participants will be randomized to the treatment arm (M-O-M-S™) or the control group (prenatal care without M-O-M-S™). Participants will complete multiple psychosocial measures questionnaires at initial recruitment and at approximately 16, 24, 28 and 32 weeks gestation. Women randomized to the M-O-M-S™ program will attend 10 sessions, lasting 1 hr. every-other-week. Maternal whole peripheral blood collection will be performed in conjunction with the participant's normal prenatal blood draw at 4-10, 16-20, and 28-32 weeks gestation. At each datapoint, blood will be collected in one 2.5 ml serum separator tube. The serum separator vacutainer will be centrifuged, and the serum placed in aliquots per participant sample. Maternal serum collected will be analyzed to quantify Th1, Th2, and Th17 cytokine levels, and oxidative stress and hormonal biomarkers. The isolated serum samples will be frozen and transported to the 59MDW CIRS laboratory at JBSA Lackland for processing, aliquoting and storage. The samples will be stored in a repository at CIRS for future comprehensive-omics analysis. Participant placentas delivered will be sent to SAMMC/BAMC pathology laboratory where the placental examination as recommended by the College of American Pathologists will be completed. Placental tissue biopsies will be collected, gross and microscopic examinations will occur. Histopathological findings will be classified according to standard guidelines and coded into categories that identify vascular malperfusion or uteroplacental vascular insufficiency, chorion regression syndrome, and other maternal inflammatory disorders. Dr. Brady (PI) and/or the pathology residents will conduct the initial examination and determine placental diagnosis, which will then be confirmed by another expert blinded to all clinical details in order to remove interpretative bias and establish interrater reliability. The placental tissue samples will also be used for proteomic analyses. Placental tissue biopsies, taken from the same locations as the tissue for the histological paraffin blocks, will be flash-frozen in liquid nitrogen. Both the serum and placental tissues will be isolated and frozen prior to transport and sent (by courier) to the 59 MDW Clinical Investigations & Research Support (CIRS) Laboratory at JBSA-Lackland for processing, aliquoting, and storage. Serum and placental tissue samples will be stored in a repository at CIRS for future comprehensive -omics analyses.

Interventions

BEHAVIORALMOMS Intervention

Behavioral: Mentors Offering Maternal Support (M-O-M-S) 10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead SponsorOTHER
59th Medical Wing
CollaboratorFED
Brooke Army Medical Center
CollaboratorFED
University of the Incarnate Word
CollaboratorOTHER
Uniformed Services University of the Health Sciences
CollaboratorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Coded histopathology slides will be sent to pathologist for evaluation with only a study number

Intervention model description

The study is a repeated measures, longitudinal design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* All Active Duty and DoD beneficiary gravid women, * 18 years of age or older, * Receiving prenatal care at BAMC, * English speaking

Exclusion criteria

* Military dependent daughters * VA beneficiaries

Design outcomes

Primary

MeasureTime frameDescription
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.at time of MOMS intervention administerCorrelate % of participants with increased measures of anxiety and depression will be associated with changes in Th1, Th2, and Th17 responses as well as an increase in hormonal and oxidative stress biomarkers indicative of a proinflammatory and physiological stressed state.
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.at time of maternal serum and placental tissue collectionCorrelate % of participants with increased measures of anxiety and depression will be associated with changes in Th1, Th2, and Th17 responses as well as an increase in hormonal and oxidative stress biomarkers within the placental tissue indicative of a pro-inflammatory and physiological stressed state that is correlative to changes in maternal serum.
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.at time of placental tissue collectionCorrelate% of participants with increased measures of pregnancy anxiety and depression will be associated with the development of maternal vascular malperfusion or uteroplacental vascular insufficiency, chorion regression syndrome, and maternal inflammatory disorders.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTony T Yuan, PhD

Uniformed Services University of the Health Sciences

PRINCIPAL_INVESTIGATORRobert O Brady, MD

59 Medical Wing

PRINCIPAL_INVESTIGATORKaren L Weis, PhD

University of Kansas Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026