Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes (MOMS Placenta)
Phase: NA
Conditions: Placental Dysfunction, Prenatal Stress
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

 
 
Title: Effects of Pregnancy-Specific Anxiety on Placental Inflammatory 
and Oxidative Stress Response and Birth Outcomes (MOMS ™ Placenta) 
Date: January 15, 2021 
NCT#: Pending 
 

EIRB Protocol Template (Version 1.10)
1.0
General Information
*Please enter the full title of your study:
Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and
Oxidative Stress Response and Birth Outcomes
*Please enter the Protocol Number you would like to use to reference the protocol:
FWH20190163H
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
No
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
USAF - 59th Medical Wing (59 MDW)
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
Brady, Robert O, MD Lt Col
Select if applicable
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
Yuan, Tony Tao 
Associate Investigator

B) Research Support Staff
Armstrong-Spenrath, LA'QUITA L 
 Team Member
Farhat, Julie Kristine, MBA 
 Team Member
Walker, Katherine C, MSN RN 
 Research Coordinator
3.3 *Please add a Protocol Contact:
 
Brady, Robert O, MD Lt Col 
Walker, Katherine C, MSN RN 
Yuan, Tony Tao 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
 
Project Information
4.1  * Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study?
If Yes, answer the questions according to the IRB/HRPP Determination.
  Yes   
  No
IRB Name
Review Date
Determination
No records have been added
4.2  * Is this a research study or a Compassionate Use/Emergency Use/HUD project?
 Yes   
 No
4.3  What type of research is this?
Biomedical Research
Clinical trial (FDA regulated)
Behavioral Research
Educational Research
Psychosocial Research
Oral History
Other
4.4  Are you conducting this project in pursuit of a personal degree?

  Yes   
  No
4.6  * Is this human subjects research? (As defined by 32 CFR 219) 
 
Human subject means a living individual about whom an investigator (whether professional or 
student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, 
and uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.7  * Do you believe this human subjects research is exempt from IRB review?
  Yes   
  No
5.0
 
Personnel Details
5.1  List any Research Team members without EIRB access that are not previously entered in the 
protocol:
Name:
(Last, First, M.I.)
Weis, Karen L.
Role on Protocol:
Principal Investigator
Phone Number:
 
210-829-3987
Email Address:
 
weis@uiwtx.edu
Associated Institution:
 
University of the 
Incarnate Word
Name:
(Last, First, M.I.)
Yuan, Tony T.
Role on Protocol:
Associate Investigator
Phone Number:
 
214-437-0541
Email Address:
 
tony.t.yuan.ctr@mail.
mil
Associated Institution:
 
USAF CAMD, 
Lackland AFB
Name:
(Last, First, M.I.)
Bustamante, Blandine
Role on Protocol:
Associate Investigator
Phone Number:
 
210-283-6374
Email Address:
 
bhelfric@uiwtx.edu
Associated Institution:
 
University of the 
Incarnate Word
Name:
(Last, First, M.I.)
Graham, Brittney S.
Role on Protocol:
Associate 
Investigator GME 
Pathology Resident
Phone Number:
 
210-916-6309
Email Address:
 
brittney.s.graham.
mil@mail.mil
Associated Institution:
 
BAMC - Pathology 
Residency

Name:
(Last, First, M.I.)
Farhat, Julie K
Role on Protocol:
Research Assistant
Phone Number:
 
210-841-7257
Email Address:
 
julie.k.farhart.
ctr@mail.mil
Associated Institution:
 
University of the 
Incarnate Word
5.2  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No
7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
:
Military Operational 
Medicine Research Program 
(MOMRP) (JPC-5)
Using current MOMS funding 
FA8650-17-2-6817
: Operations and Maintenance 
(O&M)
UIW personnel conducting 
recruitment & follow-up 
funded by current MOMS 
funding
1845943
: Other
Intramural (GME) funding - 
Funding pending
: Other
off-set costs associated with 
histologic specimens and the 
biomarker data.
0
Total amount of funding:
1845943
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
If Yes, complete and attach Conflict of Interest forms for all key personnel

8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
 Yes   
 No
8.2  Study Facilities and Locations:
Institution
Site Name
Site Role
FWA or DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
Army
Brooke 
Army 
Medical 
Center
Performance 
site
FWA00004092
06/07
/2022
: IAIR
:
WHASC 
IRB 
Protocol 
Office
University 
of the 
Incarnate 
Word
Coordinating 
center
FWA00009201
10/15
/2023
: IAIR
:
WHASC 
IRB 
Protocol 
Office
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
No records have been added
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local research 
context has been considered
  Yes   
  No
8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to study 
approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study

Placenta, Biomarkers, MOMS, Inflammatory Response, Maternal
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the protocol.  The 
background section should clearly support the choice of study variables and explain the basis for the 
research questions and/or study hypotheses.  This section establishes the relevance of the study and 
explains the applicability of its findings
Significance:
Prenatal maternal anxiety and depression have been implicated as possible risk factors for preterm birth 
(PTB) and other poor birth outcomes (Ding et al., 2014; Doktorchik et al., 2018; Reck et al., 2013). 
Preterm deliveries are considered to be one of the key indicators for national health and is the leading 
cause of neonatal death as well as the second most frequent cause of death in children aged < 5 years 
worldwide (WHO, 2012). Every year, approximately 15 million babies are born prematurely worldwide, 
which equates to 1 out of every 10 babies (WHO, 2012). In the U.S., the estimated annual cost of PTB is 
approximately 26 billon dollars (IOM, 2007), which includes maternal delivery costs, medical care for the 
infant up to age 5 years, early intervention, and disability-specific lifetime medical costs. In addition, PTB 
outcomes are closely related to low birthweights (LBW), which accounted for 22 million newborns 
worldwide in 2015. Following this report, the World Health Organization established new goals for 2025 
to decrease low birthweight (LBW) by 30% and improve maternal health (WHO, 2014). Overall, etiology 
underlying maternal mental health and its relationship to PTB and LBW is poorly understood. Literature 
has theorized that stress-associated chronic inflammation and oxidative stress leads to changes that 
disrupts immunological homestasis that then triggers preterm labor. Concurrently, stress-associated 
cellular damage can result in an acute inflammatory response and significant cytokine upregulation 
(Tsiartias, 2012). Alternatively, the disruption of normal placental development can lead to alterations in 
placental vasculogenesis and angiogenesis as well as changes in hormone and enzyme activity results in 
placental insufficiency leading to impaired fetal growth and reduced birth weight (Parra-Saavedra et al., 
2013).
 
Background and Review of Literature:
Research efforts in the investigation of reproductive health, especially as it relates to mental health of 
active-duty servicewomen, female veterans, or wives of service members is limited (Ganzer, 2016). As 
operational conditions have intensified so has the stress and anxiety experienced by the active duty 
member and their spouses (Verdeli et al., 2011). As result of these stresses, many veterans are reported 
to have long-term mental health issues associated with their service. Mental health along with physical 
condition, socioeconomic status, and the availability of social support can siginficiantly impact 
pregnancies. As operational stress and anxiety rise for active duty women coupled with lack of necessary 
social support increases the likelihood of pregnancy complications and poor birth outcomes (Dunkel-
Schetter, 2011). To better elucidate the roles of mental health and social support on birth outcomes, it is 
important to the examine how these psychological factors are manifested physiologically. Although 
literature has shown that the biopsychosocial mechanisms PTB are driven by an inflammatory/immune 
response resulting from the activation of the hypothalamic-pituitary-adrenal (HPA) axis, there are limited 
understanding the mechanisms that leads to LBW. However, it is hypothesized that elevated 
proinflammatory cytokines and C-reactive proteins (Coussons-Read et al., 2007) that is seen in PTB 
might also play role in LBW. Conceivably, inflammatory/oxidative stress responses leading to alteration 
in cellular functions and placental development affects fetal nutrient transport, which ultimately results in 
lower birth weights. Prospective studies are, in which pregnant women are followed aross pregnancy, 
with repeated measures of anxiety and symptoms of depression are needed to be compared to 
pathological placental changes and molecular biomarkers associated with poor birth outcomes.
 
 
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses
Purpose of Study:
1). Explore the associations of prenatal maternal anxiety to placental histological findings   
2). Explore the associations between prenatal maternal anxiety and the function of pro-inflammatory, 
anti-inflammatory, and immunoregulatory cells found in placental tissue.

3) Determine the effect of maternal anxiety on the association between placental molecular changes on 
pregnancy and birth and infant outcomes.
 
Hypotheses:
1a) Increased values for measures of prenatal maternal anxiety, stress, and depression will be 
associated with increased placental pathology.
2a) Increased values for measures of prenatal maternal anxiety, stress, and depression will be 
associated with increased Th1 response in respect to both Th2 and Th17 immunological response.
1b & 2b) Increased values for measures of prenatal maternal anxiety, stress, and depression will 
correspond with both increased oxidative stress and general stress hormones.
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, cohort, etc.). 
Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug research
The study is a repeated measures, longitudinal design in which Active duty and DoD beneficiary pregnant 
women, 18 years of age and older, that are currently being recruited and consented for the Mentors 
Offering Maternal Support (M-O-M-S) research program at the Brooke Army Medical Center (BAMC). 
They will also be invited to participate in the placental study, as well as pregnant women entering 
prenatal care in the first trimester, who are not in the M-O-M-S program. Women choosing not to 
participate in the M-O-M-S study can elect to participate only in the placental study. Psychosocial 
measures of prenatal anxiety, depression and resilience will be collected at study entry and 12, 16, 24, 
and 32 weeks gestation. Placentas, of women consented to this study will be obtained following delivery. 
 
No inducements, monetary or otherwise, will be offered to terminate a pregnancy [45 CFR 46.204
(h)].  Individuals engaged in the research will have no part in any decisions as to the timing, method, or 
procedures used to terminate a pregnancy [45 CFR 46.204(i)].  Individuals engaged in the research will 
have no part in determining the viability of a neonate [45 CFR 46.204(j)].
 
9.5  Target Population:
Describe the population to whom the study findings will be generalized
The target population is ALL pregnant women within the San Antonio Military Community, receiving their 
OB orientation and prenatal care at the Brooke Army Medical Center (BAMC). Military prenatal services 
are now consolidated and provided at BAMC. The San Antonio military population includes Air Force, 
Army, Navy, and Marine active-duty servicewomen, retired service women, and female military 
beneficiaries of active duty, and retirees. The intent is to generalize the findings to all military branches, 
recognizing that some of the branches may not have broad sampling within this location. On-going 
studies/data collection at 3 other military installations will provide baseline data for comparisons. The 
findings may be extrapolated to pregnancy in general.
All women attending OB orientation have had their pregnancies verified through the OB clinic. Therefore, 
additional screening is not required to confirm they are pregnant. The study inclusion criteria includes, 
being a pregnant woman, in the first trimester, Active Duty or a DoD beneficiary. The women may also 
be participants in the Mentors Offering Maternal Support study at BAMC.
 
 
 
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
Military Relevance:
The vast majority of women (97.6%) serving in the active component of the military are women of 
childbearing potential (Stahlman, Witkop, Clark, & Taubman, 2017). At the end of 2016, there were 
202,849 women serving in the active service components (Army, Navy, Air Force, or Marines), and of 
these, 197, 947 were considered women of child-bearing potential. Maternal conditions (including 

pregnancy complications and delivery) accounted for 15.3% of all hospital bed days, and is the second 
most frequent diagnoses for hospitalization among active duty females behind mental disorders (MSMR, 
2015). As the number of women serving in the military increases, it is particularly important to 
understand the relationship between mental health during pregnancy and its complications leading to 
poor birth outcomes.  
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
Subjects:
All Active Duty and DoD beneficiary gravid women, 18 years of age or older, receiving prenatal care at 
BAMC. They will be consented for the placental study and will sign a written Informed Consent Document 
and HIPAA Authorization Document for study participation.
 
Research Design and Step-by-Step Methods:
The target population is ALL pregnant women within the San Antonio Military Community, receiving their 
OB orientation and prenatal care at the Brooke Army Medical Center (BAMC) and who meet all study 
inclusion criteria, will be invited to participate in this placental study. Placentas, of women consented to 
this study will be obtained following delivery. The placental study will also include psychosocial measures 
of maternal prenatal anxiety and symptoms of depression, self-esteem, resilience and support obtained 
at various time points in the first, second and third trimester, as presented in Table 2.  
 
Table 2.
 
Variable
Measurement
  Collection
  Timepoints
Prenatal 
Maternal 
Stress and 
Anxiety – 
(Prenatal 
Adaptation)
Lederman Prenatal Self-Evaluation Questionnaire (PSEQ-
sf), 53 items (7 scales). Higher scores on a scale 
indicate greater anxiety related to the formulation of the 
motherhood role. Biochemical markers of stress in labor, 
and labor and postpartum outcomes were used to 
provide convergent and divergent construct validity; 
Cronbach’s alpha coefficients for the scales range from α 
= .75 to .92. Weis obtained similar coefficients in her 
military populations. The instrument has been factored 
with a military population and all 7 scales remained 
distinct. The scales measure the level of anxiety the 
woman is experiencing relative to the particular 
dimension.
Pregnancy:
Initial, 12, 16, 24, & 
32weeks
Self-Esteem
Rosenberg Self-Esteem Scale (RSE), 10-item scale 
measuring the degree to which one values oneself. The 
possible range of scores is 10 to 40, with higher scores 
indicating higher self-acceptance. The Cronbach’s alpha 
reliabilities range from .84 to .90. The construct validity 
of the instrument was demonstrated by examining its 
conformity to theoretical predictions. The test-retest 
reliability was found to be r = 0.85. This instrument was 
used in the pilot M.O.M.S. project with good results.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
Family 
Adaptability 
and Cohesion
Family Adaptability and Cohesion Evaluation Scales 
(FACES II) 30-item (2 scales) measuring the ability of 
the family (couple) to change its roles, rules, and power 
structure. High scores on both scales indicate extreme 
(dysfunctional) responses and low scores indicate 
flexibility, adaptability, or balance. Cronbach’s alpha 
coefficients for FACES II couples version are 0.87 for 
cohesion and 0.78 for adaptability from a National 
Survey of 1000 families. Weis has used this instrument 
with good results.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Prenatal 
Depression
Edinburgh Postnatal Depression Scale (EPDS) is a 10-
item self-report scale validated for use during pregnancy 
and the postpartum period. Scores range from 0-30; 
higher scores are associated with higher depression. 
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 

Scores of 12 or greater will be associated with prenatal 
depression. The Cronbach’s alpha has been established 
as 0.80.
 
Perceived 
Support
Social Support Index (SSI) is a 17-item instrument 
designed to measure the degree to which families are 
integrated into the community, view the community as a 
source of support, and feel that the community can 
provide emotional, esteem, and network support. The 
instrument uses a 5-point Likert scale with higher scores 
indicating more perceived, anticipated social support. 
The SSI had a .40 validity coefficient with the criterion 
measure of family well-being. Construct validity was 
assessed in a study with over 1,000 families and the 
perceived support was positively correlated with a family’
s sense of fit within the community (r = .40). The 
internal reliability of the SSI was reported as α = .82 
and test-retest reliability as α = .83.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Military 
Family 
Commitment 
and Stress
Family Index Coherence (FIC) is a 17-item instrument 
developed to measure the degree to which families feel 
committed to the military mission and identify a 
subscale of family coping to manage life changes and 
stresses. The instrument uses a 4-point Likert scale 
ranging from “Strongly Agree” (3) to “Strongly 
Disagree” (0). The internal reliability of FIC has been 
established as α = .82 and test-retest reliability of α = .
86.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Resilience
Brief Resilience Scale (BRS) is a 6-item instrument 
developed to measure the concept of “bouncing back 
from stress.” The instrument uses a 5-point Likert scale 
ranging from “Strongly Agree” (5) to “Strongly 
Disagree” (1) with a neutral measure (3). The internal 
reliability for the BRS has been established as .80-.91.
 
27
The test-retest for one month ranged from .63-.69 in 
two samples.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Pandemic 
Related 
Stress
/Anxiety
The Pandemic Related Pregnancy Stress Scale (PREPS), 
17 item instrument developed to measure the thoughts 
and concerns pregnant women might have due to the 
COVID-19 pandemic using 3 constituent factors: 
preparedness stress, perinatal infection stress, and 
 The response scale ranges from 1= 
positive appraisal.
Very Little to 5= Very Much. Stress scales are internally 
consistent with Cronbach’s alpha coefficient is >0.80.
Pregnancy: Initial,
12, 16, 24, & 32 weeks
 
Placental tissue collected after birth will be used to obtain histologic, microscopic, and molecular data. 
Pregnancy and neonatal outcome data including gestational age at delivery, infant birthweight, mode of 
delivery, and pregnancy complications, including pre-eclampsia, gestational hypertension, gestational 
diabetes, and perinatal and neonatal infections will be collected from the maternal and infant medical 
records. If missing from the demographic data form, maternal parity, gestational age at first prenatal 
appointment, ethnicity, beneficiary status (active duty vs. dependent), smoking history, and other 
medical history will be obtained from the obstetrical record. Participants will sign a HIPAA form providing 
permission to access their obstetrical records (prenatal and inpatient) for the pregnancy complications 
and neonatal/birth outcomes data.
 
  Source of Research Material
  
Standard Care? (Y/N)
  Placental tissue
  Y
  Prenatal questionnaire booklet
  N
  Outpatient Record Data (prenatal EDC 
verification/pregnancy complications)
  Y
  Inpatient Record Data (birth outcomes)
  Y
 
 
Setting:
All women attending OB orientation have had their pregnancies verified through the OB clinic. Therefore, 
additional screening is not required to confirm they are pregnant. The study inclusion criteria includes, 
being a pregnant woman, in the first trimester, Active Duty or a DoD beneficiary. The women may also 
be participants in the Mentors Offering Maternal Support study at BAMC.

Women choosing not to participate in the MOMS study can elect to participate only in the Placenta Study.
 
Date(s):
Upon final approval from the IRB and deferral from the BAMC HRPO, recruitment of participants is 
anticipated to begin in November 2019 and continue through March 2021. Birth and outcomes data will 
be retrieved from both the mother's and newborn infant's electronic medical record through December 
2021, with the study ending February 28, 2022.
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the data will 
be operationally measured.
Data Collection and Processing:
For women who have consented to participate in the study, following delivery, all placentas transported 
to Pathology are placed in a labeled tissue container and "Labor and Delivery Placenta Pathology 
Submission Form" is attached per normal standard procedures. 
 
The obstetrical provider will place the order for histology, annotating on the order submission that the 
placenta is designated as a MOMS study placenta for pathologic evaluation. Once the placenta specimens 
for this study arrive in the pathology laboratory, the appropriate lab research personnel will be notified 
and the specimen will be given a unique code for study purposes and tissue specific collection will occur. 
The placenta will undergo the usual examination in accordance with local SOPs. Additionally, unlabeled 
and coded slides of each case will be processed concurrently and collected by BAMC research personnel. 
These coded slides will be sent to Dr. Bustamante at UIW for review.
 
During the gross examination selected portions of the placenta will be taken and flash frozen, in addition 
to the usual sections taken for histology processing. The placental specimens will be reviewed by Dr. 
Brady for diagnosis based on histology. The flash frozen tissue will then be prepared for shipment to 59 
MDW Center for Advance Molecular Detection (CAMD), for the identification of immunological, 
inflammatory, and hormone biomarkers. 
 
Dr. Brady, BAMC/PI will conduct placental gross and microscopic evaluations. Frozen tissue biopsies for 
CAMD will be used for characterization and identification of specific immunological, inflammatory, and 
hormone biomarkers changes, Tissue specimens will be homogenized and divided into two groups for 
analysis: (1) RT-PCR for RNA expression; (2) Multiplexed panel for protein expression. Response groups 
will be divided into: (1) Th1, (2) Th2, (3) Hormonal, and (4) Oxidative Stress, and some of their specific 
factors.
 
The coded, flash frozen placental tissue will be stored in a -80°C freezer until they are packed by the PI 
and/or pathology resident into storage boxes appropriate for transport to the Center for Advance 
Molecular Detection (CAMD). Dry ice will not be required for immediate transport between BAMC 
pathology lab and CAMD. Project coordinator and/or the research personnel will sign for the specimens 
and verify packaging. They will be responsible to ensure the specimens are taken directly to the CAMD 
lab, where they will be signed in accordance to CAMD SOP 4-4. Specimens will be stored at -80°C, until 
sufficient specimens are available for a trimester batch run. Dr. Yuan, the senior scientist at the 59 MDW 
S&T, and a co-investigator on the study will be responsible for all tissue specimens and the requisite data.
 
Patients’ will be consented for the use of their placental tissue. Once the analysis has been run and the 
data is analyzed with the psychosocial and microscopic data, one of three things will occur according to 
the participant consent: 1) the tissue will be destroyed, 2) the tissue will be maintained as a coded 
specimen within a tissue repository at CAMD, and/or 3) coded slides will be maintained for medical 
student use at UIW School of Medicine. The tissue will be maintained until the completion of all data 
analyses as re-analysis might occur. In the process of data cleaning and analysis, questions may arise 
regarding the results requiring re-running of that “batch.” At which time it is determined that there is no 
further need for the tissue, all coded specimens and data kept at 59MDW, BAMC, and UIW will be 
handled and disposed of in accordance with federal regulations and will be destroyed at the end of all 
data mergers, or no later than at the closure of the study, based on AFI 33-332, "The Air Force Privacy 
and Civil Liberties Program" and the National Institute Standards and Technology Special Publication 
(NIST SP 800-88) for the approved methods to destroy PII. Note, the only items maintained at UIW, are 
the coded histology slides (until completion of the study, at which time, the slides will no longer be coded 
but maintained within a slide “library” for student review purposes.  There will be no patient information 
,
associated with the slides or tissue specimens.  Results of the questionnaires (maintained in an SPSS de-
,
identified dataset), and de-identified outcomes data IF the CRADA is obtained will be utilized by study PIs 
for completion of reports and publications. UIW will not be maintaining or storing any tissue samples or 
copies of patient medical records.
 

10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
 Yes   
 No
10.4  Review the definitions below and respond to the following two questions.  If you are not sure of the 
answers, email 
 for assistance.
DHA.PrivacyBoard@mail.mil
 
The 
 is defined as all DoD health plans and DoD health care providers 
Military Health System (MHS)
that are organized under the management authority of, or in the case of covered individual 
providers, assigned to or employed by, the Defense Health Agency (DHA), the Army, the Navy, or 
the Air Force
 
MHS workforce members are employees, volunteers, trainees, and other persons whose conduct, in 
the performance of work for the MHS, is under the direct control of the MHS, whether or not they 
are paid by the MHS.
 
MHS business associates are persons or entities that provide a service to the MHS and require 
protected health information (PHI) to provide the service.
Are you an MHS workforce member?
Yes, I am an MHS workforce member 
No, I am not an MHS workforce member 
Are you an MHS business associate?
Yes, I am an MHS business associate 
No, I am not an MHS business associate 
10.5  Have you consulted with an MHS data expert to determine the data elements required for your 
study?
Consulting with a data expert often saves time later in the compliance process because the data expert 
can advise on the data available in the numerous MHS information systems, the quality of that data and 
the methods for encrypting and collapsing data.  To schedule a consult with an MHS data expert, send 
an email to: (
)
DHA.PrivacyBoard@mail.mil
Yes, then complete the questions below according to the data consult 
No, then complete the questions below according to the best of your knowledge 
10.6  Indicate how you will request data from the MHS.  Select all that apply.
Talking with MHS health care providers or MHS health plans about specific research participants
Obtaining MHS hard copy records specific to research participants
Obtaining data from an MHS information system(s)
10.7  If you are obtaining data from an MHS information system(s), indicate whether you plan to receive 
a data extract or whether you plan to access an MHS information system directly to create a data 
set.
A data extract is when the MHS or a contractor provides the data set directly to the researcher.  When 
receiving a data set through data extract, the researcher may indicate whether the data elements should 
be provided as is, encrypted or collapsed.  In contrast to a data extract, access to an information system 
means that the researcher may directly access an MHS information system and create a data set for the 
research study
Data Extract
Access

10.8  Do you intend to request de-identified data from the MHS in your research study? 
There are different two methods for de-identifying data pursuant to HIPAA:
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in combination 
with other information to identify the individual who is the subject of the information
2) Statistical Method: An expert, with appropriate knowledge of and experience with generally accepted 
statistical and scientific principles and methods for rendering information not individually identifiable, 
determines that the data is not individually identifiable
  Yes   
  No
10.9  Indicate the MHS information system(s) from which you will seek to obtain data
If you do not know which system(s) contains the data elements you need, refer to the Guide for DoD 
Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA.
.
PrivacyBoard@mail.mil
 
Below is a list of commonly used MHS systems. If the system from which you seek to obtain data is not 
listed below, list the name of the system in the “Other MHS Systems” category below
PHI Systems:
MHS Information System
Requesting Data
: AHLTA
: Yes
: CHCS
: Yes
: ESSENTRIS
: Yes
PII-Only Systems:
MHS Information System
Requesting Data
No records have been added
De-Identified Data & Other Systems:
Information System
Requesting Data
No records have been added
10.10  Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS?
Yes, will merge data  
No, will not merge data 
10.11  Indicate the data elements about research participants or relatives, employers, or household 
members of the research participants that you will request from MHS hard copies or from MHS 
information systems.
If you will merge data, also indicate non-MHS data elements about research participants or 
relatives, employers, or household members of the research participants that you will have access 
to in any form or medium.
Data Element(s)
MHS
Non-MHS Systems
MHS Hard Copies
1. Names

2. Postal address with 
only town, city, state 
and zip code
3. Postal address with 
all geographic 
subdivisions smaller 
than a state, including 
street address, city, 
county, precinct, zip 
code and their 
equivalent geocodes, 
except for the initial 
three digits of a zip 
code if, according to 
the current publicly 
available data from the 
Bureau of Census: 1) 
the geographic unit 
formed by combining 
all zip codes with the 
same three initial 
digits contains more 
than 20,000 people; 
and 2) the initial three 
digits of a zip code for 
all such geographic 
units containing 
20,000 or fewer people 
is changed to 000
4. Dates including all 
elements (except year) 
directly related to an 
individual, including 
birth date, admission 
date, discharge date, 
and date of death
5. Ages over 89 and all 
elements of dates 
(including year) 
indicative of such age, 
unless you will only 
request a single 
category of “age 90 or 
older”
6. Telephone numbers
7. Fax numbers
8. Electronic mail 
addresses
9. Social Security 
numbers (SSNs)
10. Medical record 
numbers

11. Health plan 
beneficiary numbers
12. Account numbers
13. Certificate/license 
numbers
14. Vehicle identifiers 
and serial numbers, 
including license plate 
numbers
15. Device identifiers 
and serial numbers
16. Web Universal 
Resource Locators 
(URLs)
17. Internet Protocol 
(IP) address numbers
18. Biometric 
identifiers, including 
finger and voice prints
19. Full-face 
photographic images 
and any comparable 
images
20. Any other unique 
identifying number, 
characteristic, or code 
(Diagnosis, DEERS ID, 
EDI-PI, Rank)
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot be used
The last four of SSNs will only be on the participant log (key). The participant log will be password 
protected on each computer. The transfer of participant log information between sites will require a 
locked and encrypted file. The column with the last four of SSNs will be eliminated prior to any transfer 
or participant “key” information between sites.
10.12  Do you believe it is possible for the MHS data to become identifiable because of triangulation, a 
small cell size, or any unique data element(s)?
Triangulation means using different data elements that are not themselves identifiable but that when 
combined can be used to identify an individual. For example, triangulation would use rank and race 
together to determine the identity of an individual with a particular health condition.
 
Small cell size means that there is only a small number of eligible individuals that satisfy the category 
description. Guidance for acceptable cell size is available from the Centers for Medicare and Medicaid 
Services. For example, the rank category of four star generals with a particular diagnosis may be less 
than 30, so the rank category may need to be expanded to include lower ranks.
 

A unique data element includes any unique features that are not explicitly enumerated in the categories 
of data in rows 1 – 20 of the table above (in Section 10.10), but that could be used to identify an 
individual. Unique data elements include characteristics that are not themselves identifying, such as the 
rank of general or admiral, or a race or gender, but within the context of other information could be 
identifiable.
Yes, I believe there is a reasonable possibility the MHS data will become identifiable 
No, I believe there is no reasonable possibility the MHS data will become identifiable 
10.13  Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will 
be obtained or Waiver/alteration of HIPAA Authorization is being requested)?
Yes 
No 
N/A 
10.14  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during the 
study, data/specimen storage and length of time stored, shipment/transmission, and the plan for 
storage and final disposition at the conclusion of the study. Describe any data agreements in place for 
accessing data within and/or outside of your institution (e.g., Data Sharing Agreement, Data Use 
Agreement, Business Agreements, etc.)
A copy of the consent will be stored by the investigator in a locked file cabinet in a locked office, as part of 
the research record. All information about the participant, collected on this study, will be kept in an electronic 
database, which will be double password-protected, firewall-protected, and access-restricted to people 
involved in this study. Dr. Weis, the co-investigator will not have access to this dataset until which time the 
CRADA is signed and in place.  As soon as possible, any link between identity and the research information 
will be destroyed which means research information about the participant will be permanently de-identified. 
Personal identifying information and identifiable bio-specimens will be destroyed no later than at the closure 
of the study. The research information and bio-specimens collected will not be used for any additional 
research activity beyond what has been described in the consent.
 
All bio-specimens kept at the 
will be handled and 
59 MDW, BAMC or University of the Incarnate Word 
disposed of in accordance with Federal regulations and local laboratory procedures. In accordance with 
the authorization within the patient consent, once the tissue has been analyzed and run, one of three 
things will occur, 1) tissue will be destroyed, 2) the tissue will be maintained as a coded specimen within 
a tissue repository at CAMD, and/or 3) coded slides will be maintained for medical student use at UIW, 
School of Medicine.
 
Histology slides for review by Dr. Blandine Bustamante will be packed by the PI and/or pathology 
resident on the study in accordance with bio-specimen requirements. The histology slide samples will be 
coded and transported from BAMC pathology to UIW School of Medicine at Brooks-City-Base, TX.
 
All coded tissue specimens stored as a part of the CAMD Data/Tissue Repository for the purposes of this 
study - (FWH20130092H) at the 
Center for Advance Molecular Detection (CAMD) at Joint Ba
se San 
and will be handled and disposed of in accordance with Federal regulations upon 
Antonio Lackland 
termination of the repository. No individual, investigator, institution or agency will have access to this 
database without permission of the Pl or Repository Manager, 
and where applicable, the 
Dr. Tony Yuan, 
59 MDW Institutional Review Board (IRB). The Repository Manager, Dr. Tony Yuan, is responsible for all 
PHI and PII data stored in the repository.
 
Only de-identified data (data that meets the HIPAA standards for removing direct identifiers or 
information) will be released to investigators with an IRB-approved research study, so tracing specific 
information back to the donor of the data should not be possible. Recipient investigators may only 
receive limited data sets under a Data Use Agreement (DUA) including the information necessary to 
conduct their IRB-approved research. All recipient investigators requesting data from the repository must 
have approval from the Repository Manager and must have a research study approved through a DoD 
Institutional Review Board (IRB) and/or the 59 MDW IRB.  
 
Once the data is collected, an individual’s data will not be released or shared with anyone outside the 
project. Pregnancy and birth outcomes data will be collected from the participant’s prenatal record via 
the electronic medical record. All participants will complete a HIPAA form in addition to the consent form 
indicating their knowledge of the study personnel obtaining this outcome data from their medical 

Th1
Th2
Th17 (Treg)
Oxidative Stress
Stress Hormone
IFN-y
IL-3
IL-17
Hydrogen Peroxide
Prostaglandin E2
TNF- β
IL-4
IL-23
Nitric Oxide Synthase Family
Cortisol
TNF-α
IL-5
TGF-β
S-glutathionylation
CRH (HPA Axis)
IL-12p70
IL-10
 
C-reactive Protein
ATCH
IL-18
IL-13
 
 
DHEA
IL-1β
LIF
 
 
 
IL-6
 
 
 
 
IL-2
 
 
 
 
MIP-1α
 
 
 
 
records. Research coordinators, PIs, AIs will complete CITI training and HIPAA training. The procedures 
outlined above will be covered during team orientation and included within the study binders. Participant 
questionnaire booklets will be shredded once all the data has been entered into the database twice, 
cleaned and verified for correctness. Participant log (key) will be needed until all final reports are 
completed and then shredded.
 
The study also involves the collection of psychosocial data. The collection of longitudinal psychosocial 
data requires the collection of some PHI. The information needed to sustain contact with the participants 
is maintained on a separate patient identification log and is secured within a double-password protected 
folder apart from any of the patient data and tissue samples, accessible only by the PI and the project 
coordinator.
 
 
 
 
10.15  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents (either by the 
Investigator or through an established repository) for FUTURE research, address. How the specimens
/data will be used, where and how data/specimens will be stored (including shipping procedures, storage 
plan, etc.), whether and how consent will be obtained, procedures that will fulfill subjects’ request as 
stated in the consent, whether subjects may withdraw their data/specimens from storage, whether and 
how subjects may be recontacted for future research and given the option to decline, whether there will 
be genetic testing on the specimens, who will have access to the data/specimens, and the linkage, the 
length of time that data/specimens will be stored and conditions under which data/specimens will be 
destroyed.
See above section 10.14
 
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific aims, 
and/or research hypotheses.  Explain how missing data and outliers will be handled in the analysis.  The 
analysis plan should be consistent with the study objectives.  Include any sub-group analyses (e.g., 
gender or age group).  Specify statistical methods and variables for each analysis.  Describe how 
confounding variables will be controlled in the data analysis
For characterization and identification of specific immunological, inflammatory, and hormone biomarkers 
changes, placental tissue biopsies taken from the same locations as the tissue for the paraffin blocks, will 
be flash-frozen in liquid nitrogen prior to being sent (by courier) to the 59
 MDW Center of Advanced 
th
Molecular Detection (CAMD) at JBSA-Lackland. Once received, each biopsy will be homogenized and 
divided into two groups for analysis: (1)  RT-PCR for RNA expression; (2) Multiplexed panel for protein 
expression. Response groups will be divided into: (1) Th1, (2) Th2, (3) Hormonal, and (4) Oxidative 
Stress, and some of their specific factors are summaried in Table 1.
                 
 Select Immunological, Hormonal, and Oxidative Stress Factor for Analysis.
Table 1:

MIP-1β
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Specifically, analysis will explore the physiological correlations between the biomarker groups as a
response to psychosocial factors and in relation to histopathological analysis. The psychosocial
measures obtained at various timepoints in first, second, and third trimester are presented in Table 2.
 
Table 2.
 
Variable
Measurement
  Collection
  Timepoints
Prenatal 
Maternal 
Stress and 
Anxiety – 
(Prenatal 
Adaptation)
Lederman Prenatal Self-Evaluation Questionnaire (PSEQ-
sf), 53 items (7 scales). Higher scores on a scale 
indicate greater anxiety related to the formulation of the 
motherhood role. Biochemical markers of stress in labor, 
and labor and postpartum outcomes were used to 
provide convergent and divergent construct validity; 
Cronbach’s alpha coefficients for the scales range from α 
= .75 to .92. Weis obtained similar coefficients in her 
military populations. The instrument has been factored 
with a military population and all 7 scales remained 
distinct. The scales measure the level of anxiety the 
woman is experiencing relative to the particular 
dimension.
Pregnancy:
Initial, 12, 16, 24, & 
32weeks
Self-Esteem
Rosenberg Self-Esteem Scale (RSE), 10-item scale 
measuring the degree to which one values oneself. The 
possible range of scores is 10 to 40, with higher scores 
indicating higher self-acceptance. The Cronbach’s alpha 
reliabilities range from .84 to .90. The construct validity 
of the instrument was demonstrated by examining its 
conformity to theoretical predictions. The test-retest 
reliability was found to be r = 0.85. This instrument was 
used in the pilot M.O.M.S. project with good results.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
Family 
Adaptability 
and Cohesion
Family Adaptability and Cohesion Evaluation Scales 
(FACES II) 30-item (2 scales) measuring the ability of 
the family (couple) to change its roles, rules, and power 
structure. High scores on both scales indicate extreme 
(dysfunctional) responses and low scores indicate 
flexibility, adaptability, or balance. Cronbach’s alpha 
coefficients for FACES II couples version are 0.87 for 
cohesion and 0.78 for adaptability from a National 
Survey of 1000 families. Weis has used this instrument 
with good results.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Prenatal 
Depression
Edinburgh Postnatal Depression Scale (EPDS) is a 10-
item self-report scale validated for use during pregnancy 
and the postpartum period. Scores range from 0-30; 
higher scores are associated with higher depression. 
Scores of 12 or greater will be associated with prenatal 
depression. The Cronbach’s alpha has been established 
as 0.80.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
 
Perceived 
Support
Social Support Index (SSI) is a 17-item instrument 
designed to measure the degree to which families are 
integrated into the community, view the community as a 
source of support, and feel that the community can 
provide emotional, esteem, and network support. The 
instrument uses a 5-point Likert scale with higher scores 
indicating more perceived, anticipated social support. 
The SSI had a .40 validity coefficient with the criterion 
measure of family well-being. Construct validity was 
assessed in a study with over 1,000 families and the 
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 

perceived support was positively correlated with a family’
s sense of fit within the community (r = .40). The 
internal reliability of the SSI was reported as α = .82 
and test-retest reliability as α = .83.
Military 
Family 
Commitment 
and Stress
Family Index Coherence (FIC) is a 17-item instrument 
developed to measure the degree to which families feel 
committed to the military mission and identify a 
subscale of family coping to manage life changes and 
stresses. The instrument uses a 4-point Likert scale 
ranging from “Strongly Agree” (3) to “Strongly Disagree” 
(0). The internal reliability of FIC has been established 
as α = .82 and test-retest reliability of α = .86.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Resilience
Brief Resilience Scale (BRS) is a 6-item instrument 
developed to measure the concept of “bouncing back 
from stress.” The instrument uses a 5-point Likert scale 
ranging from “Strongly Agree” (5) to “Strongly Disagree” 
(1) with a neutral measure (3). The internal reliability 
for the BRS has been established as .80-.91.
 The test-
27
retest for one month ranged from .63-.69 in two 
samples.
Pregnancy:
Initial, 12, 16, 24, & 
32 weeks
 
Pandemic 
Related 
Stress
/Anxiety
The Pandemic Related Pregnancy Stress Scale (PREPS), 
17 item instrument developed to measure the thoughts 
and concerns pregnant women might have due to the 
COVID-19 pandemic using 3 constituent factors: 
preparedness stress, perinatal infection stress, and 
 The response scale ranges from 1= 
positive appraisal.
Very Little to 5= Very Much. Stress scales are internally 
consistent with Cronbach’s alpha coefficient is >0.80.
Pregnancy: Initial,
12, 16, 24, & 32 weeks
 
 
Pregnancy and neonatal outcome data including gestational age at delivery, infant birthweight, mode of 
delivery, and pregnancy complications, including pre-eclampsia, gestational hypertension, gestational 
diabetes, and perinatal and neonatal infections, will be collected from the maternal and infant medical 
records. If missing from the demographic data form, maternal parity, gestational age at first prenatal 
appointment, ethnicity, beneficiary status (active duty vs. dependent), smoking history, and other 
medical history will be obtained from the obstetrical record. The participants have signed a HIPPA form 
as part of the MOMS study and all data mentioned is being collected as a part of this study.
 
11.2  Sample Size:
1200
11.3  Total number of subjects requested (including records and specimens):
1200
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
N/A
11.5  Please provide a justification for your sample size
There are approximately 1500 deliveries a year at the San Antonio Military Medical Center. 
Approximately 1100 (73%) of delivered placentas are sent for pathologic examination. Approximately 
45% of the placentas are found to have some type of pathology. Given the percentage of placental 
pathology within this population, 1200 deliveries would be required to compare differences in placental 
tissue to psychosocial measures with a power of 80% and significance of .05.
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:

1.  
2.  
3.  
Data Analysis Plan:
Statistical Analysis System (SAS) version 9.4 will be used for all analyses. Descriptive statistics (mean, 
sd, median for each continuous variable and proportions for each discrete variable) will be used to 
describe the sample. Linear or generalized linear mixed models will be developed for all variables, 
prenatal anxiety, self-esteem, family adaptability/cohesion, prenatal depression and perceived support, 
as well as the protein and RNA values, in order to examine their association with placental metrics across 
pregnancy. The linear (mixed) model will be used for all normally distributed continuous data. In the 
case of skewed continuous outcome data, the generalized linear (mixed) model with gamma distribution 
and log-link will be chosen. For binary or dichotomized outcomes, a mixed model logistic regression will 
be chosen. Measurement times (dates of data collection by gestational age), will be included in the 
models as predictors when available with and without adjusting for the participant’s age, employment 
status, prior deliveries, marital/partner status, education, deployment of partner during pregnancy, 
military branch of service of participant or partner, ethnicity, military rank of participant or partner and 
MOMS group. In the case of dual military couples, the rank and service of the active duty woman will be 
used. The final models will be determined with backward elimination procedure. Timing of data collection 
(weeks gestation), may also be chosen as a random effect within the model. Additionally, each prenatal 
variable (prenatal anxiety, self-esteem, depression, family adaptability/cohesion and resilience) will be 
longitudinally regressed on measurement time to obtain the slope through best linear unbiased predictor 
(BLUP). The resulted individual slopes will be used to determine any significant effects for prenatal 
psychosocial scores to pregnancy complications, birth and infant outcomes, and to the physiologic data 
(both placental scores and biomarker data).
 
To examine if anxiety mediates the relationship between biomarkers and birth outcomes, we will develop 
a Baron and Kenny (1986) mediation model assess the relationships as in Bauer and Preacher (2006). 
We will conduct three mixed regression models adjusted for all appropriate covariates:
Regress birth outcome on biomarker.
Regress birth outcome on biomarker and anxiety.
Regress anxiety on biomarker.
For the above regression models, (1) and (2) will use logistic regression and (3) will use linear or a 
generalized linear model.
12.0
 
Participant Information
12.1  Subject Population:
The target population is ALL pregnant women within the San Antonio Military Community, receiving their 
OB orientation and prenatal care at the Brooke Army Medical Center (BAMC). Military prenatal services 
are now consolidated and provided at BAMC. The San Antonio military population includes Air Force, 
Army, Navy, and Marine active-duty servicewomen, retired service women, and female military 
beneficiaries of active duty, and retirees. The intent is to generalize the findings to all military branches, 
recognizing that some of the branches may not have broad sampling within this location. On-going 
studies/data collection at 3 other military installations will provide baseline data for comparisons. The 
findings may be extrapolated to pregnancy in general.
All women attending OB orientation have had their pregnancies verified through the OB clinic. Therefore, 
additional screening is not required to confirm they are pregnant. The study inclusion criteria includes, 
being a pregnant woman, in the first trimester, Active Duty or a DoD beneficiary. The women may also 
be participants in the Mentors Offering Maternal Support study at BAMC.
 
 
 
 
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does not 
match the range(s) selected, please specify in the text box.
0-17

18-24
25-34
35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Inclusion: Prima or multigravida; 1  trimester of pregnancy at consent; ≥ 18 years 
st
old;  wife or DoD beneficiary (Active Duty or retiree) partner to a military service member 
or retiree or a DoD beneficiary member (Active Duty, retiree). If the pregnant woman is 
not a DoD or TRICARE beneficiary, than Secretarial Designee (SECDES) status approval 
must be obtained in order for her to be eligible to participate in the research study, based 
on DoDI 6025.23.
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Exclusion: Anticipated permanent change of station during study; dependent daughter 
of active duty or retired military member; > 12 weeks gestation at consent; < 18 years 
of age; inability to understand or speak English; non-sponsored DoD members (civilians).
 

13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
The study inclusion criteria includes, being a pregnant woman, in the first trimester, Active Duty or a DoD 
beneficiary. The women may also be participants in the Mentors Offering Maternal Support study at BAMC. All 
women attending OB orientation have had their pregnancies verified through the OB clinic. Therefore, 
additional screening is not required. 
Identification of participants will occur in the following ways:
1) Women entering OB care within the first trimester of pregnancy (≤ 12 weeks) will be introduced to the 
study by research team members in person or by phone. For those women indicating interest in participating 
they will be provided the study information, a review of the inclusion/exclusion criteria for participation and 
the informed consent documents.
 
2) Women who are not contacted by phone may be met in person during OB orientation to discuss the study 
or have the option of setting up another more convenient time to meet with the research team members.
 
3) Potential participants may also be accessed in the OB clinic after the OB orientation appointment if they 
express a desire to hear more about the study/meet with a team member. If the patient does not have time 
to stay after the OB orientation to meet with a study member they may elect to complete the Inclusion
/Exclusion screening form with contact information and the research team members will follow-up with a 
phone call.
 
4) Potential participants will also be given the option to receive their ICD and HIPAA documents via email 
form which will be signed by wet signature or electronically signed and returned to a research team 
member who will review the ICD and the HIPPA forms.
         a) Each electronic signature will have a date stamp incorporated with it at the time of signature. 
[NOTE: without a date stamp, the electronic signature is not valid]
         b) The investigator will have some means to personally verify the subject's identification, e.g., compare 
with a State-issued or government-issued ID; a driver's license; use of personal security questions; etc. This 
must be done BEFORE the investigator sanctions the acceptance of an individual's electronic signature. [The 
investigator must state the means of verification in their research files for audit purposes.]
          c) After the research team member administering the consent, signs and dates the ICD, a copy of the 
signed ICD will be given to the subject. The ICD and HIPPA form will be signed prior to any data collection. 
 
Once consented, the participant will then be asked to complete the first study booklet. If the participant 
chooses to review/complete the study documents at home rather than at their appointment they can 
complete them, through the web-based, Qualtrics system, specifically designed for collecting anonymous 
research content.
 
Participation in the study is a voluntary activity. Every participant indicating a desire to participate in the 
study will be consented in person prior to completion of any study documents or interview. The time and 
place of consent will vary depending on the means of recruitment (see options above). If the participant is 
recruited in person, then the consent process can be conducted at the same time. However, if the participant 
has called indicating interest in the study or been recruited through a phone call, determination is made 
between the study staff and participant regarding an appropriate process to review/sign the consent 
documents. 
 
 
13.2  Compensation for Participation:
There is no compensation.
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text 
editor

Note that all women attending OB orientation have had their pregnancies verified. Additional screening 
for pregnancy is not required. Determination of the Inclusion/Exclusion criteria will be made with the 
screening form (see attachment form).
13.4  Consent Process:
 
Revised Common Rule, Section 219.116:  General requirements for informed consent, whether 
written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the 
requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be 
obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this 
section only with respect to the storage, maintenance, and secondary research uses of identifiable 
private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Consenting will occur in the following ways:
1. Potential participants will be consented by a research team member in a private area located in the OB
/Gyn clinic. The participant will be provided the study information and if the patient is interested in 
participating in the study, they will be given the Informed Consent Document and HIPAA Authorization 
Documents (mother and infant) for review and signature. The ICD’s (mother and infant) will be signed 
authorizing participation in the study. The research team member will review the forms with the patient. 
Both forms must be signed before any study-related data collection occurs. The participant will be given 
copies of the signed  documents. Potential participants have the option to discuss with family members 
prior to signing consent documents. 
 
2. Potential participants will also be given the option to receive their ICD and HIPAA documents via email 
form which will be signed by wet signature or electronically signed and returned to a research team 
member who will review the ICD and the HIPPA forms.
         a) Each electronic signature will have a date stamp incorporated with it at the time of signature. 
[NOTE: without a date stamp, the electronic signature is not valid]
         b) The investigator will have some means to personally verify the subject's identification, e.g., 
compare with a State-issued or government-issued ID; a driver's license; use of personal security 
questions; etc. This must be done BEFORE the investigator sanctions the acceptance of an individual's 
electronic signature. [The investigator must state the means of verification in their research files for 
audit purposes.]
          c) After the research team member administering the consent, signs and dates the ICD, a copy of 
the signed ICD will be given to the subject. The ICD and HIPPA form will be signed prior to any data 
collection. 
 
Once consented, the participant will then be asked to complete the first study booklet. If the participant 
chooses to review/complete the study documents at home rather than at their appointment they can 
complete them, through the web-based, Qualtrics system, specifically designed for collecting anonymous 
research content.
 
 
 
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:
Explain the process for withdrawal and specify whether or not the subjects will be given the opportunity 
to withdraw their data their data/specimens in the event they wish to withdraw from the study

Participants are free to withdraw at any time. The decision to withdraw will not affect subjects' ability to 
receive medical care and will not be penalized or lose any benefits to which the subject would otherwise 
be entitled. If a subject withdraws from the study, all the associated data and tissue samples will be 
destroyed. 
 
 
 
 
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach of 
confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do not describe 
risks from standard care procedures; only describe risks from procedures done for research purposes
There is minimal risk for participating in this study. Personal information (the questionnaire booklets 
and demographic data) are securely maintained on a password protected computer with a secured 
study folder.  The paper documents will be locked in a file cabinet in the private secured office of the 
nurse researcher.  Only members of the research team, listed on the research protocol, will have any 
access to the information.  The demographic information will be entered into an electronic 
spreadsheet that is password protected.  The data from the questionnaire booklets and the placental 
tissue data are entered into a computer data program with no identifiable information.  This program 
is also password protected.  At the conclusion of the study, all documents will be shredded.  The 
slides and tissue biopsies will be destroyed unless the research subject consents to maintain the 
placenta tissue and research data in a data/tissue repository.
 
Participants could experience emotional distress or anxiety that may affect their well-being or their 
unborn infant. There may be feelings of isolation, particularly if one’s husband/partner is away. No 
inducements, monetary or otherwise, will be offered to terminate a pregnancy [45 CFR 46.204(h)]. 
Individuals engaged in the research will have no part in any decisions as to the timing, method, or 
procedures used to terminate a pregnancy [45 CFR 46.204(i)]. Individuals engaged in the research 
will have no part in determining the viability of a neonate [45 CFR 46.204(j)].
 
The Principal Investigator and members of the research team are not the research participant’s 
healthcare provider.  Participants will be informed to always notify their provider or nurse in the 
obstetrical clinic immediately if they need help. 
 
 
 
 
 
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate risk of 
harms to subjects and study personnel
A copy of the consent will be stored by the investigator in a locked file cabinet in a locked office, as part of 
the research record. All information about the participant, collected on this study, will be kept in an electronic 
database, which will be double password-protected, firewall-protected, and access-restricted to people 
involved in this study. Dr. Weis, the co-investigator will not have access to this dataset until which time the 
CRADA is signed and in place.  As soon as possible, any link between identity and the research information 
will be destroyed which means research information about the participant will be permanently de-identified. 
Personal identifying information and identifiable bio-specimens will be destroyed no later than at the closure 

of the study. The research information and bio-specimens collected will not be used for any additional 
research activity beyond what has been described in the consent.
 
All bio-specimens kept at the 
will be handled and 
59 MDW, BAMC or University of the Incarnate Word 
disposed of in accordance with Federal regulations and local laboratory procedures. In accordance with 
the authorization within the patient consent, once the tissue has been analyzed and run, one of three 
things will occur, 1) tissue will be destroyed, 2) the tissue will be maintained as a coded specimen within 
a tissue repository at CAMD, and/or 3) coded slides will be maintained for medical student use at UIW, 
School of Medicine.
 
Histology slides for review by Dr. Blandine Bustamante will be packed by the PI and/or pathology 
resident on the study in accordance with bio-specimen requirements. The histology slide samples will be 
coded and transported from BAMC pathology to UIW School of Medicine at Brooks-City-Base, TX.
 
All coded stored as a part of the CAMD Data/Tissue Repository for the purposes of this study - 
(FWH20130092H) at the Center for Advance Molecular Detection (CAMD) at Joint Base San Antonio 
and will be handled and disposed of in accordance with Federal regulations upon termination of 
Lackland 
the repository. No individual, investigator, institution or agency will have access to this database without 
permission of the Pl or Repository Manager, 
and where applicable, the 59 MDW 
Dr. Tony Yuan, 
Institutional Review Board (IRB). 
 
The Repository Manager, Dr. Tony Yuan, is responsible for all PHI and PII data stored in the repository. 
Only de-identified data (data that meets the HIPAA standards for removing direct identifiers or 
information) will be released to investigators with an IRB-approved research study, so tracing specific 
information back to the donor of the data should not be possible. Recipient investigators may only 
receive limited data sets under a Data Use Agreement (DUA) including the information necessary to 
conduct their IRB-approved research. All recipient investigators requesting data from the repository must 
have approval from the Repository Manager and must have a research study approved through a DoD 
Institutional Review Board (IRB) and/or the 59 MDW IRB.  
 
Once the data is collected, an individual’s data will not be released or shared with anyone outside the 
project. Pregnancy and birth outcomes data will be collected from the participant’s prenatal record via 
the electronic medical record. All participants will complete a HIPAA form in addition to the consent form 
indicating their knowledge of the study personnel obtaining this outcome data from their medical 
records. Research coordinators, PIs, AIs will complete CITI training and HIPAA training. The procedures 
outlined above will be covered during team orientation and included within the study binders. Participant 
questionnaire booklets will be shredded once all the data has been entered into the database twice, 
cleaned and verified for correctness. Participant log (key) will be needed until all final reports are 
completed and then shredded.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and records 
throughout the study and at its conclusion (e.g., destruction, long term storage, or banking). Explain the 
plan for securing the data (e.g., use of passwords, encryption, secure servers, firewalls, and other 
appropriate methods). If data will be shared electronically with other team members/collaborators 
outside the institution, describe the method of transmission and safeguards to maintain confidentiality. 
Explain whether this study may collect information that State or Federal law requires to be reported to 
other officials or ethically requires action, e.g., child or spouse abuse
There is the potential risk for loss of confidentiality, although every effort will be made to protect 
participant confidentiality.
The research team will secure the ICD, HIPAA and any study related documents as indicated above. 
When recruiting, no items will be left unattended, and all consent items will be maintained in envelopes. 
Participant consents will be scanned into a separate password-protected file from all other study data 
and submitted to the IRB annually. The paper copies of all the participant consents will be scanned at the 
study site into a password-protected file, separate from all other study data, and paper copies of 
participant consents will be shredded. Personal information are securely maintained on a password 
protected computer with a secured study folder. Documents will be locked in a file cabinet in the private 
secured office of the nurse program coordinator. Only members of the research team, listed on the 
research protocol, will have any access to the information. The demographic information will be entered 
into an electronic spreadsheet that is password protected. The data from the questionnaire booklets and 
the placental tissue data are entered into a computer data program with no identifiable information. This 
program is also password protected. At the conclusion of the study, all documents will be shredded.

Participants could experience emotional distress or anxiety that may affect the well-being of themselves 
or their unborn infant. There may be feelings of isolation, particularly if one’s husband/partner is away. It 
is expected that some participants will have unexpected terminations of their pregnancy. All events that 
are life-threatening or fatal will be reported within 24 hours. Any other possible adverse events 
(expected or unexpected) will be reported to the local IRB as well as the governing IRB at BAMC and at 
the WHASC according to their guidelines.
See section 14.2 for additional information.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits to a 
specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and they 
cannot provide their own consent, the protocol must describe the intent to directly benefit all subjects
As the number of women serving in the military increases, it is particularly important to understand the 
relationship between mental health during pregnancy and its complications leading to poor birth 
outcomes.  There is no guarantee or promise that the subjects will receive any personal benefit from this 
All the women in the 
study. We hope the information learned from this study may help future patients.  
study will be aware that the findings as applicable will be used to update the VA/DoD Clinical Practice 
Guideline for Pregnancy Management and as norming data for assessment tools used within the DoD.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and all 
research activities, etc.
Potential participants will be consented by a research team member in a private area or if emailed for 
electronic signature, a) Each electronic signature will have a date stamp incorporated with it at the time 
of signature. [NOTE: without a date stamp, the electronic signature is not valid] b) The investigator will 
have some means to personally verify the subject's identification, e.g., compare with a State-issued or 
government-issued ID; a driver's license; use of personal security questions; etc. This must be done 
BEFORE the investigator sanctions the acceptance of an individual's electronic signature. [The 
investigator must state the means of verification in their research files for audit purposes.] c) After the 
research team member administering the consent, signs and dates the ICD, a copy of the signed ICD will 
be given to the subject. The ICD and HIPPA form will be signed prior to any data collection. 
 
The research team will review the ICD and HIPAA Authorization forms with the patient. Both forms must 
be signed before any study-related data collection occurs, including pre-screening procedures to verify 
inclusion/exclusion criteria for study participation. The participant will be given copies of both documents 
(ICD for placental study, and the HIPPA form). Additionally, the mother will be given a Parental ICD and 
a Parental HIPAA Authorization for signature, authorizing her infant to be part of the study and to permit 
the investigators to access the infant's medical record for birth and infant outcome data. Once 
consented, the participant will then be asked to complete the first study booklet. If the participant 
chooses to review/complete the study documents at home rather than at their appointment they can 
complete them, through the web-based, Qualtrics system, specifically designed for collecting anonymous 
research content.
 
The research team will secure the ICD, HIPAA and any study related documents in an envelope that is 
kept with the research team at all times; no items will be left unattended. Participant consents will be 
scanned into a separate password-protected file from all other study data and submitted to the IRB 
annually. The paper copies of all the participant consents will be scanned at the study site into a 
password-protected file, separate from all other study data, and paper copies of participant consents will 
be shredded.
 
Personal information are securely maintained on a password protected computer with a secured study 
folder.  Documents will be locked in a file cabinet in the private secured office of the nurse 
researcher.  Only members of the research team, listed on the research protocol, will have any access to 

the information.  The demographic information will be entered into an electronic spreadsheet that is 
password protected.  The data from the questionnaire booklets and the placental tissue data are entered 
into a computer data program with no identifiable information.  This program is also password 
protected.  At the conclusion of the study, all documents will be shredded.  The slides and tissue biopsies 
will be destroyed unless the participant consents to maintaining the placenta tissue and research data in 
a data/tissue repository.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject could 
possibly benefit medically or otherwise from the information, state whether or not the results of 
screening, research participation, research tests, etc., will be shared with subjects or their primary care 
provider. State whether the researcher is obligated or mandated to report results to appropriate military 
or civilian authorities and explain the potential impact on the subject
Complete confidentiality cannot be promised, particularly for active duty personnel, because 
information regarding potential UCMJ violations or concerns regarding fitness for duty may be 
reported to appropriate medical, law enforcement, or command authorities. If an investigator feels 
at any time that a participant is at risk of self-harm, the participant will be given a direct referral to a 
provider within the Mental Health Services and their provider notified. Complete confidentiality for 
active duty pregnant women cannot be guaranteed. Importantly, Mental Health Service 
appointments do not have any connection with the study or participation in the study.
 
No blood will be taken as a part of this study.  The afterbirth (the placenta) will be sent to pathology 
for examination as part of this study.  If the subject is wanting to obtain the placenta following birth, 
it can still be requested and obtained through pathology, in the same manner it would be obtained if 
they were not in this study.  If a placental examination is requested by the physician following 
delivery, this can and will take place regardless of whether participating in the study. 
 
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse events will 
be for this study, describe the likelihood (frequency, severity, reversibility, short-term management and 
any long-term implications of each expected event)

 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address how 
unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or consent 
form are needed and the scale that will be used to grade the severity of the adverse event
There is the potential risk for loss of confidentiality, although every effort will be made to protect 
participant confidentiality. The research team will secure the ICD, HIPAA and any study related 
documents as indicated above. When recruiting, no items will be left unattended, and all consent items 
will be maintained in envelopes. Participant consents will be scanned into a separate password-protected 
file from all other study data and submitted to the IRB annually. The paper copies of all the participant 
consents will be scanned at the study site into a password-protected file, separate from all other study 
data, and paper copies of participant consents will be shredded. Personal information are securely 
maintained on a password protected computer with a secured study folder. Documents will be locked in a 
file cabinet in the private secured office of the nurse program coordinator. Only members of the research 
team, listed on the research protocol, will have any access to the information. The demographic 
information will be entered into an electronic spreadsheet that is password protected. The data from the 
questionnaire booklets and the placental tissue data are entered into a computer data program with no 
identifiable information. This program is also password protected. At the conclusion of the study, all 
documents will be shredded.
Participants could experience emotional distress or anxiety that may affect the well-being of themselves 
or their unborn infant. There may be feelings of isolation, particularly if one’s husband/partner is away. It 
is expected that some participants will have unexpected terminations of their pregnancy. All events that 
are life-threatening or fatal will be reported within 24 hours. Any other possible adverse events 
(expected or unexpected) will be reported to the local IRB as well as the governing IRB at BAMC and at 
the WHASC according to their guidelines.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements

19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
References and Glossary
20.1  References:
Bibliography:
Anonymous (2015). Hospitalizations among members of the active component, U.S. Armed Forces,
          2014. 
(4), 11-17.
Medical Surveillance Monthly Report, 22
Baron, R. M., & Kenny, D. A. (1986). The moderator-mediator variable distinction in social
        psychological research: Conceptual, strategic and statistical considerations. Journal of
        Personality and Social Psychology, 51, 1173-1182.
Bauer, D. J., Preacher, K. J., & Gil, K. M. (2006). Conceptualizing and testing random indirect effects
        and moderated mediation in multilevel models: New procedures and recommendations.
        Psychological Methods, 11, 142-163.
Coussons-Read, M. E. Okun, M. L., & Nettles, C. D. (2007). Psychosocial stress increases
        inflammatory markers and alters cytokine production across pregnancy. Brain, Behavior, and
        Immunity, 21, 43-50.
Ding, X. X., Wu, Y. L., Xu, S. J., Zhu, R. P., Jia, X. M., Zhang, S. F.,. . .Tao, F. B. (2014). Maternal
        anxiety during pregnancy and adverse birth outcomes: A systematic review and meta-analysis
        of prospective cohort studies. 
, 159, 103-110.
Journal of Affective Disorders
Doktorchik, C., Premji, S., Slater, D., Williamson, T., Tough, S., & Pattern, S. (2018). Patterns of
       change in anxiety and depression during pregnancy predict preterm birth. Journal of Affective
       Disorders, 227, 71-78.
Dunkel-Schetter, C. (2011). Psychological science on pregnancy: Stress processes, 
       biopsychosocial models, and emerging research issues. 
,
Annual Review of Psychology, 62
       531-58.
Ganzer, C. A. (2016). Veteran women: Mental health – related consequences of military service.
       American Journal of Nursing, 116(11), 32-39.
Institute of Medicine (US) [IOM] Committee on Understanding Premature Birth and Assuring
     Healthy Outcomes (2007). Behrman RE, Butler AS, editors. Washington (DC): Nation                 
     Academies Press (US) Reck, C., Zimmer, K., Dubber, S., Zipser, B., Schlehe, B., & Gawlik, S.
    (2013).
Parra-Saavedra, M., Crovetto, F., Triunfo, S., et al. (2013). Placental findings in late-onset SGA
      births without Doppler signs of placental insufficiency.
34(12):1136-41. doi: 
 Placenta. 
      10.1016/j.placenta.2013.09.018.
Stahlman, S., Witkop, C. T., Clark, L. L., & Taubman, S. B. (2017). Pregnancies and live births,
      active component service women, U.S. Armed Forces, 2012-2016. Medical Surveillance Monthly
      Report, 24(11), 2-9.
The influence of general anxiety and childbirth-specific anxiety on birth outcome. Archives of     
          Women’s Mental Health, 16, 363-369.
Tsiartas, P., Holst, R. M., Wennerolm, U. B., Haberg, H., Hougaard, D. M., Skogstrand, K., . . .
     Jacobsson, B. (2012). Prediction of spontaneous preterm delivery in women with threatened
     preterm labour: A prospective cohort study of multiple proteins in maternal serum. British Journal
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World Health Organization (2012). Born to soon. The Global action report on preterm birth. C.P.
      Howson, M.V. Kinney, & J.E. Lawn (Eds). Geneva: World Health Organization.
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      treating depression in military spouses. 
(4), 488-496.
Journal of Family Psychology, 25
World Health Organization (2014). Global nutrition targets 2025: Low birth weight policy brief
      (WHO/NMH/NHD/14.5). Geneva: World Health Organization.

20.2  Abbreviations and Acronyms:
AD Active Duty
BAMC Brooke Army Medical Center 
CAMD Center of Advanced Molecular Detection
CPA College of American Pathologists 
CRH corticotropin-releasing hormone
HIPPA Health Insurance Portability and Accountability
HPA hypothalamic-pituitary adrenal
LBW Low Birthweight
M-O-M-S Mentors Offering Maternal Support
Non-AD Non-Active Duty
PTB Preterm Birth
SAMMC San Antonio Military Medical Center
Th1 T Helper Cells Type 1 Cytokines
Th2 T Helper Cells Type 2 Cytokines
Th17 T Helper Cells Type 17 (IL-17 or Interleukin 17) Cytokines
TNF-α Tumor Necrosis Factor - alpha