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

NCT04993742 | Active Not Recruiting

• 1 other identifier: FWH20190163H
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Placental Dysfunction; Prenatal Stress

Keywords

placenta; prenatal; pregnancy; maternal anxiety; prenatal depression; biomarker

Outcome Measures

Primary Outcomes (3)

• 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.

  Correlate % 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.

  at time of MOMS intervention administer

• 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.

  Correlate % 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.

  at time of maternal serum and placental tissue collection

• 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.

  Correlate% 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.

  at time of placental tissue collection

Study Arms (1)

MOMS Intervention

EXPERIMENTAL

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

Behavioral: MOMS Intervention

Interventions

MOMS Intervention BEHAVIORAL

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.

MOMS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Military dependent daughters
• VA beneficiaries

Sponsors & Collaborators

• 59th Medical Wing: collaborator
• Brooke Army Medical Center: collaborator
• University of the Incarnate Word: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Joint Base San Antonio

San Antonio, Texas, 78236, United States

Location

Related Publications (4)

• Weis KL, Yuan TT, Walker KC, Gibbons TF, Chan W. Associations between Physiological Biomarkers and Psychosocial Measures of Pregnancy-Specific Anxiety and Depression with Support Intervention. Int J Environ Res Public Health. 2021 Jul 29;18(15):8043. doi: 10.3390/ijerph18158043.

  PMID: 34360332 RESULT

• Weis KL, Ryan TW. Mentors offering maternal support: a support intervention for military mothers. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):303-314. doi: 10.1111/j.1552-6909.2012.01346.x.

  PMID: 22834852 RESULT

• Weis KL, Lederman RP, Lilly AE, Schaffer J. The relationship of military imposed marital separations on maternal acceptance of pregnancy. Res Nurs Health. 2008 Jun;31(3):196-207. doi: 10.1002/nur.20248.

  PMID: 18213640 RESULT

• Weis KL, Lederman RP, Walker KC, Chan W. Mentors Offering Maternal Support Reduces Prenatal, Pregnancy-Specific Anxiety in a Sample of Military Women. J Obstet Gynecol Neonatal Nurs. 2017 Sep-Oct;46(5):669-685. doi: 10.1016/j.jogn.2017.07.003. Epub 2017 Jul 24.

  PMID: 28751158 RESULT

Study Officials

• Tony T Yuan, PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• Robert O Brady, MD

  59 Medical Wing

  PRINCIPAL INVESTIGATOR

• Karen L Weis, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Coded histopathology slides will be sent to pathologist for evaluation with only a study number
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a repeated measures, longitudinal design

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: August 6, 2021
• Study Start: November 26, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)