Placental DysfunctionMOMSPlacentaNCT04993742
Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes
A study testing MOMS Intervention in people with Placental Dysfunction and Prenatal Stress, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placental Dysfunction, Prenatal Stress
- What is being tested?
- MOMS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Active Duty and DoD beneficiary gravid women,
- 18 years of age or older,
- Receiving prenatal care at BAMC,
- English speaking
Who cannot join
- Military dependent daughters
- VA beneficiaries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes (MOMS Placenta)
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.
Read the 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.
- Conditions
- Placental Dysfunction, Prenatal Stress
- Being tested
- MOMS Intervention
- Keywords
- placenta, prenatal, pregnancy, maternal anxiety, prenatal depression, biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMS InterventionBehavioural
Behavioral: Mentors Offering Maternal Support (M-O-M-S) 10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.
| Study group | Role | What they receive |
|---|---|---|
| MOMS Intervention | Experimental | Women that are currently in the Mentors Offering Maternal Support (M-O-M-S) research program as well as pregnant women entering prenatal care in the first trimester, who are not in the M-O-M-S program may participate in the study.
Arms Assigned Interventions Experimental: M-O-M-S Intervention M-O-M-S intervention is 10, 1 hour prenatal mentored support groups
No Intervention: Routine Prenatal Care Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines Receives: Behavioral: MOMS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore associations between prenatal maternal psychosocial measures of anxiety depression with immunological, oxidative stress, and hormonal biomarker changes found in maternal serum with and without the M-O-M-S™ support intervention.
Correlate % of participants with increased measures of anxiety and depression will be associated with changes in Th1, Th2, and Th17 responses as well as an increase in hormonal and oxidative stress biomarkers indicative of a proinflammatory and physiological stressed state.
Measured: at time of MOMS intervention administer
Explore associations between prenatal maternal psychosocial measures of anxiety depression with immunological, oxidative stress, and hormonal biomarker changes found in placental tissue with and without the M-O-M-S™ pregnancy intervention.
Correlate % of participants with increased measures of anxiety and depression will be associated with changes in Th1, Th2, and Th17 responses as well as an increase in hormonal and oxidative stress biomarkers within the placental tissue indicative of a pro-inflammatory and physiological stressed state that is correlative to changes in maternal serum.
Measured: at time of maternal serum and placental tissue collection
Explore associations between prenatal maternal psychosocial measures of anxiety and depression to histopathology changes in placental tissue with and without the M-O-M-S™ intervention.
Correlate% of participants with increased measures of pregnancy anxiety and depression will be associated with the development of maternal vascular malperfusion or uteroplacental vascular insufficiency, chorion regression syndrome, and maternal inflammatory disorders.
Measured: at time of placental tissue collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start26 Nov 2019
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Placental DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a repeated measures, longitudinal design
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- 59th Medical Wing, Brooke Army Medical Center, University of the Incarnate Word, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Tony T Yuan, PhD, Principal investigator, Uniformed Services University of the Health SciencesRobert O Brady, MD, Principal investigator, 59 Medical WingKaren L Weis, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993742
- Sponsor's protocol ID
- FWH20190163H
- Acronym
- MOMSPlacenta
- Status last verified
- Feb 2026
- First submitted
- 2 Nov 2020
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34360332Weis 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.
PubMed 22834852Weis 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.
PubMed 18213640Weis 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.
PubMed 28751158
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes (MOMS Placenta)
- ClinicalTrials.gov ID
- NCT04993742
- Acronym / sponsor ID
- MOMSPlacenta / FWH20190163H
- Conditions
- Placental Dysfunction, Prenatal Stress
- Keywords
- placenta, prenatal, pregnancy, maternal anxiety, prenatal depression, biomarker
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- 59th Medical Wing, Brooke Army Medical Center, University of the Incarnate Word, Uniformed Services University of the Health Sciences
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a repeated measures, longitudinal design
| Arm | Type | Receives |
|---|---|---|
| MOMS Intervention | Experimental | Behavioral: MOMS InterventionWomen that are currently in the Mentors Offering Maternal Support (M-O-M-S) research program as well as pregnant women entering prenatal care in the first trimester, who are not in the M-O-M-S program may participate in the study. Arms Assigned Interventions Experimental: M-O-M-S Intervention M-O-M-S intervention is 10, 1 hour prenatal mentored support groups No Intervention: Routine Prenatal Care Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All Active Duty and DoD beneficiary gravid women,
- 18 years of age or older,
- Receiving prenatal care at BAMC,
- English speaking
Key exclusion criteria (2 listed)
- Military dependent daughters
- VA beneficiaries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOMS InterventionBehavioral: Mentors Offering Maternal Support (M-O-M-S) 10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support. | Behavioural | MOMS Intervention |
Primary outcome
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.
Time frame: at time of MOMS intervention administer
Correlate % of participants with increased measures of anxiety and depression will be associated with changes in Th1, Th2, and Th17 responses as well as an increase in hormonal and oxidative stress biomarkers indicative of a proinflammatory and physiological stressed state.
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.
Time frame: at time of maternal serum and placental tissue collection
Correlate % of participants with increased measures of anxiety and depression will be associated with changes in Th1, Th2, and Th17 responses as well as an increase in hormonal and oxidative stress biomarkers within the placental tissue indicative of a pro-inflammatory and physiological stressed state that is correlative to changes in maternal serum.
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.
Time frame: at time of placental tissue collection
Correlate% of participants with increased measures of pregnancy anxiety and depression will be associated with the development of maternal vascular malperfusion or uteroplacental vascular insufficiency, chorion regression syndrome, and maternal inflammatory disorders.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: PubMed 34360332Weis 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.
- Results publication: PubMed 22834852Weis 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.
- Results publication: PubMed 18213640Weis 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.
- Results publication: PubMed 28751158Weis 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.
Related trials for Placental Dysfunction
RecruitingObservational study
Cardiometabolic Disease and Substrate Metabolism
Preeclampsia, Gestational Diabetes Mellitus (GDM)
RecruitingObservational study
Cardiometabolic Health in First Time Pregnancy
Cardiometabolic Health, Pregnancy Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony T Yuan, PhD principal investigator
Uniformed Services University of the Health Sciences
Robert O Brady, MD principal investigator
59 Medical Wing
Karen L Weis, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMS Intervention in people with Placental Dysfunction and Prenatal Stress, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: at time of MOMS intervention administer). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993742, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.