MOMS Intervention for Prenatal Stress

(MOMSPlacenta Trial)

Overseen By Katherine Walker-Rodriguez, MSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Disqualifiers: Military dependent daughters, VA beneficiaries

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 32 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stress during pregnancy affects the placenta and, in turn, the baby's health. The study tests an approach called the MOMS Intervention, which involves support groups for expectant mothers. Researchers aim to determine if these support groups can reduce stress and improve pregnancy and birth outcomes. Pregnant women who are active duty or Department of Defense beneficiaries, receive prenatal care at BAMC, and speak English may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to understanding stress management during pregnancy and its impact on maternal and infant health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MOMS Intervention is safe?

Research has shown that prenatal wellness classes, such as the MOMS Intervention, are generally safe and well-received. One study found that similar classes reduced depression in mothers by half, with benefits lasting up to eight years. These findings suggest that such programs are not harmful and may offer long-term mental health benefits. Additionally, programs that manage stress during pregnancy have successfully improved stress levels, benefiting both mothers and their babies. These results support the safety of participating in the MOMS Intervention, highlighting its positive effects without significant negative outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOMS Intervention because it offers a unique approach to managing prenatal stress through a supportive community environment. Unlike traditional prenatal care, which primarily focuses on physical health and medical check-ups, this intervention provides pregnant women with 10 one-hour mentored support groups. These sessions aim to address emotional well-being by fostering peer support and mentorship, which can be crucial during pregnancy. This focus on mental health and community support sets the MOMS Intervention apart, offering an additional layer of care that could enhance maternal and fetal outcomes.

What evidence suggests that the MOMS Intervention is effective for prenatal stress?

Research shows that the MOMS Intervention, available to participants in this trial, can help reduce anxiety during pregnancy. Studies have found that joining this program lowers worries about becoming a mother and preparing for motherhood. The program includes support groups that offer emotional help, effectively reducing stress during pregnancy. Although the main focus is on anxiety, it might also help expectant mothers feel more connected to their babies. These findings suggest that the program holds promise for managing anxiety during pregnancy. ^{6 7 8 9 10}

Who Is on the Research Team?

Monica Lutgendorf, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Robert O Brady, MD

Principal Investigator

59 Medical Wing

Tony T Yuan, PhD

Principal Investigator

Uniformed Services University of the Health Sciences

Karen L Weis, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for pregnant women who are active duty or DoD beneficiaries, at least 18 years old, receiving prenatal care at SAMMC, and speak English. It aims to understand how anxiety during pregnancy affects the placenta and baby's health.

Inclusion Criteria

Receiving prenatal care at SAMMC

All Active Duty and DoD beneficiary gravid women

English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the M-O-M-S intervention or routine prenatal care, with multiple psychosocial measures and blood collections at specified gestational weeks

32 weeks

Multiple visits at 16, 24, 28, and 32 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with placental and serum analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MOMS Intervention

Trial Overview The study is examining the MOMS Intervention to see if it can reveal links between maternal anxiety and changes in the placenta. It also looks at how these changes might influence both pregnancy outcomes and infant health.

How Is the Trial Designed?

Group I: MOMS Intervention Experimental Treatment 1 Intervention

Women that are currently in the Mentors Offering Maternal Support (M-O-M-S) research program as well as pregnant women entering prenatal care in the first trimester, who are not in the M-O-M-S program may participate in the study. Arms Assigned Interventions Experimental: M-O-M-S Intervention M-O-M-S intervention is 10, 1 hour prenatal mentored support groups No Intervention: Routine Prenatal Care Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

University of the Incarnate Word

Collaborator

Trials

18

Recruited

2,500+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

Published Research Related to This Trial

A study involving 24 low-income, urban women revealed that they experience high levels of stress during pregnancy, primarily due to financial strain, exposure to violence, and feelings of isolation, which can negatively impact maternal and child health.

Participants expressed a strong desire for support through connections with other women to alleviate stress, highlighting the need for healthcare providers to facilitate these connections as part of prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal stress exposures, reactions, and priorities for stress reduction among low-income, urban women. Bloom, T., Glass, N., Curry, MA., et al.[2021]

A study is underway involving 240 pregnant women with a history of mental disorders or psychosocial vulnerabilities to evaluate the effectiveness of an adapted Mindfulness-Based Stress Reduction (MBSR) program in improving mental wellbeing and reducing stress during pregnancy.

The primary goal is to assess mental wellbeing nine months after randomization, with secondary outcomes including anxiety, depression, and maternal attachment, highlighting the potential of MBSR as a non-pharmacological intervention for enhancing perinatal mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. Skovbjerg, S., Sumbundu, A., Kolls, M., et al.[2023]

The study involving 33 fetuses found that maternal relaxation techniques, particularly guided imagery (GI), positively influenced fetal behavior, with increased long-term heart rate variation compared to a control group.

Women practicing progressive muscle relaxation (PMR) exhibited more uterine activity than those using GI or the control group, suggesting that different relaxation methods may have varying effects on maternal and fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal response to abbreviated relaxation techniques. A randomized controlled study. Fink, NS., Urech, C., Isabel, F., et al.[2011]

Maternal stress is a significant factor that may increase the risk of preterm birth, but its effects can vary depending on the context and specific circumstances of the pregnancy.

There is a need for more research to identify which subgroups of pregnant women are particularly vulnerable to the negative impacts of stress, as well as to understand the biological mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of maternal stress to preterm birth: issues and considerations. Wadhwa, PD., Entringer, S., Buss, C., et al.[2023]

Mind-body interventions, including mindfulness, cognitive behavioral therapy, relaxation techniques, and yoga, significantly reduce stress in pregnant women, with a large effect size (SMD=-0.94) based on a systematic review of 28 studies involving 1944 participants.

These interventions not only lower antenatal stress but also help reduce anxiety and depression during pregnancy, suggesting they are safe and effective options for managing mental health in expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. Guo, P., Zhang, X., Liu, N., et al.[2021]

A study involving 110 pregnant women showed that applied relaxation training significantly reduced anxiety and perceived stress compared to those who only received routine prenatal care.

The findings suggest that teaching relaxation techniques can be an effective way to improve the psychological health of pregnant women, highlighting the importance of mental well-being during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of applied relaxation training on reducing anxiety and perceived stress in pregnant women. Bastani, F., Hidarnia, A., Kazemnejad, A., et al.[2008]

Provider-based stress-reducing interventions during pregnancy, such as skills-building, mindfulness, behavioral therapy, and group support, can improve mood and reduce stress among pregnant individuals, particularly those from marginalized communities.

The review analyzed 23 studies and found that while the overall effectiveness of these interventions varies, group-based therapies that combine multiple approaches tend to be more beneficial in addressing maternal stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. Moore, N., Abouhala, S., Maleki, P., et al.[2023]

A study involving 72 family members of pregnant women showed that group counseling significantly reduced perceived stress and anxiety levels among families of primiparous mothers during delivery, with p-values indicating strong statistical significance (p < 0.001).

The intervention demonstrated that cognitive group counseling effectively alleviated both hidden and obvious anxiety in families, suggesting that supporting family members can positively impact the well-being of pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the effect of group counseling on family stress and anxiety of primiparous mothers during delivery. Alaem, F., Jalali, A., Almasi, A., et al.[2022]

Mindfulness-based interventions (MBIs) have a small but significant positive effect on mental health outcomes in pregnant women, particularly reducing stress and anxiety, based on a systematic review of 13 studies involving randomized controlled trials and quasi-experimental designs.

While MBIs showed moderate effects on stress (SMD = -0.59) and anxiety (SMD = -0.55), they did not have a significant impact on depression (SMD = -0.33), indicating that while MBIs can help with certain mental health issues during pregnancy, they may not be as effective for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Mindfulness-Based Intervention on Mental Health Outcomes in Pregnant Woman: A Systematic Review and Meta-Analysis. Sari, YP., Hsu, YY., Nguyen, TTB.[2023]

The SMART Moms/Mamás LÍSTAS Project demonstrated that an 8-week prenatal stress management program significantly reduced stress and cortisol levels in 55 low-income pregnant women, with improvements in both negative and positive mood states.

Key implementation factors, such as the instructor's adherence to the intervention and participants' use of relaxation skills, were strongly associated with the program's success, emphasizing the importance of delivery fidelity in stress management interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of a Stress Management Program for Low-Income Pregnant Women: The SMART Moms/Mamás LÍSTAS Project. Urizar, GG., Caliboso, M., Gearhart, C., et al.[2021]

A prenatal cognitive behavioral stress management (CBSM) intervention effectively reduced salivary cortisol levels, a stress marker, in mothers and their infants at six and 18 months postpartum, compared to usual care.

Infants of mothers in the CBSM group had significantly lower cortisol levels than those in the usual care group at six months postpartum, indicating potential long-term health benefits from stress management during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a prenatal cognitive-behavioral stress management intervention on salivary cortisol levels in low-income mothers and their infants. Urizar, GG., Muñoz, RF.[2022]

A pilot study involving 59 pregnant patients showed that using a mindfulness app significantly reduced perceived stress levels by an average of 6.3 points between the second and third trimesters, compared to a historical control group.

Despite limited adherence to the app, the findings suggest that prenatal mindfulness practices could be a valuable nonpharmacologic intervention for managing stress during pregnancy, offering a low-cost and accessible option for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness Application for Reducing Prenatal Stress. Porter, AC., Hunter, S., Noonan, K., et al.[2022]

Preventive antenatal interventions do not significantly reduce maternal distress during pregnancy, as shown by a meta-analysis of six trials involving 2793 participants, which reported a negligible effect size.

In contrast, treatment interventions for women already experiencing or at risk of maternal distress demonstrated a significant reduction in distress, with a moderate effect size observed in three trials involving 270 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antenatal interventions to reduce maternal distress: a systematic review and meta-analysis of randomised trials. Fontein-Kuipers, YJ., Nieuwenhuijze, MJ., Ausems, M., et al.[2018]

Citations

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Mentors Offering Maternal Support Reduces Prenatal ... Participation in the MOMS program reduced pregnancy-specific prenatal anxiety for the dimensions of Identification With a Motherhood Role and Preparation for ...

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Mentors Offering Maternal Support Reduces Prenatal, ... Conclusion: Participation in the MOMS program reduced pregnancy-specific prenatal anxiety for the dimensions of Identification With a Motherhood Role and ...

3. researchfeatures.com researchfeatures.com/wp-content/uploads/2022/01/Karen-L.-Weis.pdf

The Mentors Offering Maternal Support (M-O-M-S™) ... DATA COLLECTION. All participants completed questionnaires in each trimester, which included psychological measures relating to pregnancy-specific anxiety, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S026661382400281X

Effectiveness of the mom supports mom peer ... The telephone-based peer support intervention MSM is effective in reducing stress and anxiety and increasing prenatal attachment but does not reduce depression ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06876051

Prenatal Intervention of Maternal Stress - Breastfeeding & ... This trial will provide insight into the potential benefits of prenatal stress reduction for both maternal and infant health outcomes. "If prenatal stress ...

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Effects of prenatal stress on pregnancy and human ... A growing body of research shows that prenatal stress can have significant effects on pregnancy, maternal health and human development across the lifespan.

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Prenatal Wellness Classes Cut Moms' Depression in Half ... A low-cost, prenatal intervention benefits mothers' mental health up to eight years later, a new UCSF study finds.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3423333/

Impact of a Prenatal Cognitive-Behavioral Stress Management ... These results suggest that prenatal CBSM interventions may be efficacious in regulating biological markers of stress among mothers and their infants, thereby ...

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High levels of maternal stress during pregnancy linked to ... Children whose mothers are highly stressed, anxious or depressed during pregnancy may be at higher risk for mental health and behavior ...

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Effects of interventions for women and their partners to ... The aim of this review is to systematically examine effects of interventions for women and their partners to reduce or prevent stress and/or anxiety during the ...