Behavioral Intervention for CMV in Pregnancy

Overseen By Karen B Fowler, DrPH

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Immune globulin, Ganciclovir

Disqualifiers: Fetal anomalies, Immune impairment, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program can help prevent cytomegalovirus (CMV) infections during pregnancy. Participants will either receive education on reducing CMV risks (CMV Risk-Reduction Intervention) or receive messages about stress reduction. Women in prenatal care before 20 weeks with specific CMV blood test results may qualify. The goal is to discover if CMV-focused education can lower the risk of contracting the virus during pregnancy. As an unphased trial, this study allows participants to contribute to important research that could enhance prenatal care and reduce CMV risks for future mothers.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those planning to use immune globulin, ganciclovir, or valganciclovir. If you are on these medications, you may need to stop them to participate.

What prior data suggests that this behavioral intervention is safe for pregnant women?

Research has shown that educating pregnant women about preventing cytomegalovirus (CMV) infections can be effective. When expectant mothers learn prevention strategies, they often adopt safer habits, such as improved hygiene, which lowers their risk of infection.

This educational approach poses no safety concerns. By focusing on information and guidance, it is generally well-received and has no known negative effects. This method remains safe as it does not involve medications or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CMV Risk-Reduction Intervention because it offers a proactive and educational approach to preventing cytomegalovirus (CMV) infections during pregnancy. Unlike traditional treatments that focus on managing CMV after infection, this intervention emphasizes prevention through targeted education and continuous support via text messaging. By empowering pregnant individuals with knowledge and practical tips, this method could potentially reduce the incidence of CMV, which is a leading cause of birth defects. This educational and preventive strategy represents a shift from reactive to proactive care in managing CMV risks.

What evidence suggests that this trial's interventions could be effective in preventing CMV infections during pregnancy?

Studies have shown that educating pregnant women about CMV and promoting good hygiene can help prevent infections. In this trial, participants in the CMV Risk-Reduction Intervention arm will receive personal education and follow-up text messages to reduce CMV infection risk. Research indicates that such programs during pregnancy help mothers adopt habits that lower the risk of CMV infection. Although no national guidelines exist for reducing CMV risk, these early findings suggest that focused educational efforts can be effective. These steps aim to protect both mothers and their babies from CMV during pregnancy. ^{4 5 6 7 8}

Who Is on the Research Team?

Karen B Fowler

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for pregnant women who are early in their prenatal care (before 20 weeks gestation) and have tested negative or nonprimary positive for CMV. It's not suitable for those planning to deliver outside of the University of Alabama at Birmingham hospital, with known major fetal anomalies, planned pregnancy termination, or use of certain antiviral drugs.

Inclusion Criteria

enrollment in prenatal care before 20 weeks gestation

I either do not have CMV antibodies or have a past CMV infection not affecting my current pregnancy.

Exclusion Criteria

You are pregnant and planning to end the pregnancy.

known major fetal anomalies or demise

pre-enrollment blood, ultrasound, or amniotic fluid testing indicating congenital infection with rubella, syphilis, varicella, parvovirus, toxoplasmosis or other congenital infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a CMV risk-reduction intervention or stress-reduction messaging, including a one-on-one session, a video, a take-home packet, and weekly text messages for 12 weeks

12 weeks

1 visit (in-person), weekly text messages

Follow-up

Participants attend follow-up visits at 6 and 12 weeks for specimen collection and assessment of intervention outcomes

6 weeks

2 visits (in-person)

Monitoring until Delivery

Participants are monitored for CMV viral loads, seroconversion, and reinfections until delivery, with specimen collection at various intervals

up to 32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CMV Risk-Reduction Intervention
• Stress Reduction Messaging

Trial Overview The study tests a brief behavioral intervention aimed at reducing the risk of catching CMV during pregnancy. Participants will receive information on how to lower their chances of infection as well as stress reduction messaging.

How Is the Trial Designed?

Group I: CMV Risk-Reduction Intervention Experimental Treatment 1 Intervention

One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages

Group II: Stress Reduction Messaging Placebo Group 1 Intervention

One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The Mothers and Babies (MB) course is a promising cognitive-behavioral intervention aimed at reducing depressive symptoms in low-income women at high risk for perinatal depression, with evidence supporting its efficacy.

The intervention materials are available in both English and Spanish and can be adapted for various settings and formats, indicating potential for broad dissemination and effectiveness in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Perinatal Depression in High Risk Women: Moving the Mothers and Babies Course from Clinical Trials to Community Implementation. Le, HN., Perry, DF., Mendelson, T., et al.[2021]

A study involving 78 low-income pregnant women showed that a group-based cognitive behavioral intervention (Mothers and Babies Course) significantly reduced depressive symptoms compared to usual home visiting services, with improvements observed at 1 week, 3 months, and 6 months post-intervention.

At the 6-month follow-up, only 15% of women who participated in the MB intervention experienced a major depressive episode, compared to 32% in the usual care group, highlighting the effectiveness of integrating mental health interventions into home visitation programs for preventing perinatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients. Tandon, SD., Leis, JA., Mendelson, T., et al.[2022]

The cognitive-behavioral therapy (CBT) intervention significantly reduced depressive symptoms during pregnancy among 217 high-risk Latina participants, particularly for those who attended at least 4 classes.

Despite the reduction in symptoms, the overall incidence of major depressive episodes was similar between the CBT group (7.8%) and usual care group (9.6%), indicating that while CBT was effective in symptom management, it did not significantly lower the rate of clinical depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a preventive intervention for perinatal depression in high-risk Latinas. Le, HN., Perry, DF., Stuart, EA.[2021]

Prenatal counseling significantly increased the likelihood of women quitting alcohol (72.9% vs 27.1%) and tobacco (79.9% vs 20.1%) use, indicating its effectiveness in promoting healthier behaviors during pregnancy.

Women who received counseling were also more likely to use postpartum contraception (83.6% vs 16.4%), suggesting that such counseling can positively influence maternal health decisions beyond pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial risk, prenatal counseling and maternal behavior: findings from PRAMS, 2004-2008. Krans, EE., Davis, MM., Schwarz, EB.[2018]

Perinatal depression significantly contributes to preventable health issues during and after childbirth, yet effective and accessible treatment options are limited, especially for marginalized groups.

The authors are piloting a new intervention called Center M, which adapts Mindfulness-Based Cognitive Therapy to improve access and appeal for preventing perinatal depression, addressing barriers in standard prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Mindfulness-Based Cognitive Therapy for Perinatal Depression to Improve Access and Appeal of Preventive Care. Tilden, EL., Holmes, LR., Vasquez Guzman, CE., et al.[2023]

A brief prenatal behavioral intervention significantly improved maternal behaviors related to cytomegalovirus (CMV) infection risk, with a 3-point greater increase in compliance scores compared to standard care (P=.007).

The intervention also positively influenced participants' perceptions of risk and self-efficacy regarding CMV infection, indicating that educational strategies can effectively enhance awareness and behavior change in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial. Hughes, BL., Gans, KM., Raker, C., et al.[2021]

Home-based psychological interventions, including cognitive behavioral, psychodynamic, and non-directive counseling approaches, have been shown to significantly reduce postpartum depression (PPD) in four out of six studies reviewed.

The review highlights the need for further research to identify factors that influence the effectiveness of these interventions and to develop targeted prevention strategies for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of home-based interventions to prevent and treat postpartum depression. Leis, JA., Mendelson, T., Tandon, SD., et al.[2018]

The systematic review identified the 10-item Edinburgh Postnatal Depression Scale and the Postpartum Depression Screening Scale as the most reliable tools for detecting major depression disorder (MDD) in mothers, showing high sensitivity (0.63-0.94) and specificity (0.83-0.98) during both antepartum and postpartum periods.

The study analyzed 74 articles and found that diagnostic performance varied significantly based on the prevalence of MDD in the population, indicating that the effectiveness of these screening tools may depend on the specific timing around childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of major depression disorder case-finding instruments used among mothers of young children in the United States: A systematic review. Owora, AH., Carabin, H., Reese, J., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10675417/

Cytomegalovirus Infection in Pregnancy Prevention and ... Educational interventions and proper hygiene are effective measures to avoid CMV infection in pregnant women. Caring for preschoolers while ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1201971225003893

Cytomegalovirus infection prevention counselling during ... Among the 10 866 women interviewed, 1737 (16·0%) reported being counselled about CMV during pregnancy. ... Primiparous, compared with multiparous, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04879784

Primary Prevention of Cytomegalovirus in Pregnancy ... There are currently no national policies that recommend CMV risk reduction measures in pregnancy. The overarching aim of project is to establish and build ...

4. reporter.nih.gov reporter.nih.gov/search/rPrSagr8SU-qgF7EIo6DLQ/project-details/10817837

Prenatal behavioral intervention to prevent maternal ... The long-term goal of this research is to reduce congenital cytomegalovirus (cCMV) infections by an efficacious prenatal CMV risk-reduction intervention ...

5. withpower.com withpower.com/trial/phase-cytomegalovirus-infections-2021-676b9

Behavioral Intervention for CMV in Pregnancy A brief prenatal behavioral intervention significantly improved maternal behaviors related to cytomegalovirus (CMV) infection risk, with a 3-point greater ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04615715

Prenatal Behavioral Intervention to Prevent Maternal ... Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy. ClinicalTrials.gov ID NCT04615715. Sponsor University of Alabama at ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12365723/

Provider‐Led Interventions to Reduce Congenital ... Provider‐led education on cytomegalovirus (CMV) risk reduction increases maternal preventive behaviors and should be included in preconception and prenatal ...

8. mdpi.com mdpi.com/2673-4184/5/2/11

Assessing the Scope of Evidence-Based Interventions and ... Pregnant women are considered to be at a higher risk of CMV, specifically those that have frequent exposure to young children, close contact with bodily fluids, ...