Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Cytomegalovirus Congenital Clinical Trial

Official title:

Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615715
• Other study ID #: IRB-300004979
• Secondary ID: R01HD098352
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Karen B Fowler, DrPH
• Phone: 205 638 2549
• Email: kfowler[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.

Description:

Pregnant women will be recruited into the study following their first prenatal visit. After enrollment, they will be randomized to either the CMV risk-reduction intervention or an attention-matched control stress-reduction group stratified by their CMV serostatus.

Women in both groups will attend an individualized behavioral skills session, watch a short video, receive a take-home packet, receive weekly text messages for 12 weeks that reinforce the experimental and control health messages, and attend follow-up visits at 6 and 12 weeks. Saliva, urine, vaginal, and blood specimens will be collected at enrollment and 6 and 12 weeks follow-up visits. Additionally, at-home saliva and vaginal specimen collection will occur at 3 and 9 weeks and once during the third trimester of pregnancy. At delivery, a saliva specimen will be collected from both the mother and infant, along with a remnant cord blood specimen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 840
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 39 Years

Eligibility

Inclusion Criteria:

• enrollment in prenatal care before 20 weeks gestation

• absence of CMV IgG on serological testing indicating CMV seronegative status or CMV positive (nonprimary) defined as maternal CMV infection pre-dating pregnancy defined by a high IgG avidity index or a positive CMV IgG in the presence of a negative CMV immunoglobulin M (IgM)

Exclusion Criteria:

• known major fetal anomalies or demise

• planned termination of pregnancy

• planned use of immune globulin, ganciclovir, or valganciclovir

• maternal immune impairment (e.g., HIV infection, organ transplant on anti-rejection medications)

• pre-enrollment ultrasound suggestive of established fetal CMV infection or positive fetal CMV results from culture or PCR

• pre-enrollment CMV seroconversion or primary CMV infection in pregnancy

• unable to determine if CMV infection is a nonprimary infection due to intermediate or undefined CMV serological test results

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

• intention of the patient or of the managing obstetricians for the delivery to be outside of the University of Alabama at Birmingham hospital

Related Conditions & MeSH terms

• Cytomegalovirus Congenital
• Cytomegalovirus Infections
• Maternal Cytomegalovirus Infections

Intervention

Behavioral:
• CMV Risk-Reduction Intervention
CMV Risk-Reduction Intervention
• Stress Reduction Messaging
Stress Reduction Messaging

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CMV viral loads	CMV viral loads indicated by the quantity of CMV DNA by PCR in saliva, urine, vaginal, or blood specimens.	Enrollment(baseline) until delivery, up to 32 weeks
Other	Risk factors for CMV infections	Identification of possible CMV exposures during pregnancy through self-reported exposure questionnaires given at baseline, 6 weeks, and 12 weeks.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Other	Change in anxiety after intervention	Changes in anxiety measured by the Kessler-10 Psychological Distress Scale (K10) administered pre- and post-intervention. K10 scores range from 10 to 50, with 50 indicating highest risk of anxiety.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Other	Change in CMV knowledge	Change in CMV knowledge indicated by self-report on CMV knowledge questionnaire administered pre- and post-intervention to all participants. The questionnaire will be assigned a score of 0 -18 based on the participants' answers, with a higher score indicating desired CMV knowledge.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Other	Acceptability of the educational intervention	Acceptability of prevention messages measured post-intervention by a study assessment questionnaire that provides participant feedback and rating of the intervention at 12 weeks.	Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Primary	CMV seroconversion rate in CMV seronegative women	CMV seroconversion is defined as the development of CMV immunoglobulin G (IgG) antibody in the serum of women who did not have antibodies previously. The CMV seroconversion rate will be assessed in participants.	Enrollment (baseline) until delivery, up to 32 weeks
Primary	CMV reinfections in women with non-primary infections	Reinfection will be defined by a combination of strain-specific serologic assays, next-generation sequencing, and virus shedding. The number of CMV reinfections will be assessed in participants.	Enrollment(baseline) until delivery, up to 32 weeks
Secondary	Change in self-reported CMV risk behaviors and protective behaviors	Change in the CMV risk behaviors and protective behaviors self-reported on the CMV risk behaviors questionnaire at 12 weeks post intervention.	Enrollment (baseline) to 12 weeks after enrollment (follow-up)
Secondary	Frequency of CMV shedding	Number of participants shedding CMV in their specimens collected during pregnancy. CMV shedding is indicated by the presence of CMV DNA by polymerase chain reaction assay (PCR) in saliva, urine, vaginal, or blood specimens.	Enrollment(baseline) until delivery, up to 32 weeks
Secondary	Proportion of infants with congenital CMV	The proportion of infants with a positive saliva PCR test for CMV in the first 21 days of life.	Delivery
Secondary	Frequency of new CMV variants	Number of participants with new CMV variants identified by a combination of serological screening assays and next generation sequencing of viral DNA.	Enrollment(baseline) until delivery up to 32 weeks