Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes (MOMS Placenta)
| Registry | NCT04993742, acronym MOMSPlacenta |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 150 (Estimated) |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine (Other); collaborators: 59th Medical Wing, Brooke Army Medical Center, University of the Incarnate Word, Uniformed Services University of the Health Sciences |
| Conditions | Placental Dysfunction, Prenatal Stress |
| Interventions | MOMS Intervention (Behavioral) |
| Dates | start 2019-11-26, primary completion 2026-09-30 (estimated), completion 2026-12-31 (estimated), first posted 2021-08-06, last updated 2026-02-12 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Placental Dysfunction All trials for Prenatal Stress All trials of MOMS Intervention
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MOMS Intervention | Experimental | Behavioral: MOMS 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 |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Joint Base San Antonio | San Antonio, Texas | United States |