Clinical trial NCT04993742: Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes
Official title: Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes (MOMS Placenta)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placental Dysfunction
Prenatal Stress
Keywords: placenta
prenatal
pregnancy
maternal anxiety
prenatal depression
biomarker
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: 59th Medical Wing
name: Brooke Army Medical Center
name: University of the Incarnate Word
name: Uniformed Services University of the Health Sciences
First posted: 2021-08-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a repeated measures, longitudinal design
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: at time of MOMS intervention administer
measure: 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.
timeFrame: at time of maternal serum and placental tissue collection
measure: 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.
timeFrame: at time of placental tissue collection
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Joint Base San Antonio
state: Texas
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Monica Lutgendorf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 59 Medical Wing
name: Robert O Brady, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniformed Services University of the Health Sciences
name: Tony T Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Karen L Weis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.