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

Primary Purpose

Maternal Cytomegalovirus Infections, Cytomegalovirus Congenital

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CMV Risk-Reduction Intervention
Stress Reduction Messaging
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Cytomegalovirus Infections

Eligibility Criteria

14 Years - 39 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CMV Risk-Reduction Intervention

Stress Reduction Messaging

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 21, 2020
Last Updated
March 2, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04615715
Brief Title
Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
Official Title
Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Cytomegalovirus Infections, Cytomegalovirus Congenital

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Laboratory personnel will not know the participant's intervention status.
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CMV Risk-Reduction Intervention
Arm Type
Experimental
Arm Description
One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages
Arm Title
Stress Reduction Messaging
Arm Type
Placebo Comparator
Arm Description
One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages
Intervention Type
Behavioral
Intervention Name(s)
CMV Risk-Reduction Intervention
Intervention Description
CMV Risk-Reduction Intervention
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction Messaging
Intervention Description
Stress Reduction Messaging
Primary Outcome Measure Information:
Title
CMV seroconversion rate in CMV seronegative women
Description
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.
Time Frame
Enrollment (baseline) until delivery, up to 32 weeks
Title
CMV reinfections in women with non-primary infections
Description
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.
Time Frame
Enrollment(baseline) until delivery, up to 32 weeks
Secondary Outcome Measure Information:
Title
Change in self-reported CMV risk behaviors and protective behaviors
Description
Change in the CMV risk behaviors and protective behaviors self-reported on the CMV risk behaviors questionnaire at 12 weeks post intervention.
Time Frame
Enrollment (baseline) to 12 weeks after enrollment (follow-up)
Title
Frequency of CMV shedding
Description
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.
Time Frame
Enrollment(baseline) until delivery, up to 32 weeks
Title
Proportion of infants with congenital CMV
Description
The proportion of infants with a positive saliva PCR test for CMV in the first 21 days of life.
Time Frame
Delivery
Title
Frequency of new CMV variants
Description
Number of participants with new CMV variants identified by a combination of serological screening assays and next generation sequencing of viral DNA.
Time Frame
Enrollment(baseline) until delivery up to 32 weeks
Other Pre-specified Outcome Measures:
Title
CMV viral loads
Description
CMV viral loads indicated by the quantity of CMV DNA by PCR in saliva, urine, vaginal, or blood specimens.
Time Frame
Enrollment(baseline) until delivery, up to 32 weeks
Title
Risk factors for CMV infections
Description
Identification of possible CMV exposures during pregnancy through self-reported exposure questionnaires given at baseline, 6 weeks, and 12 weeks.
Time Frame
Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Title
Change in anxiety after intervention
Description
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.
Time Frame
Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Title
Change in CMV knowledge
Description
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.
Time Frame
Enrollment(baseline) to 12 weeks after enrollment (follow-up)
Title
Acceptability of the educational intervention
Description
Acceptability of prevention messages measured post-intervention by a study assessment questionnaire that provides participant feedback and rating of the intervention at 12 weeks.
Time Frame
Enrollment(baseline) to 12 weeks after enrollment (follow-up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen B Fowler, DrPH
Phone
205 638 2549
Email
kfowler@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen B Fowler
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen B Fowler, DrPH
Phone
205-996-7791
Email
kfowler@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Requests for data sharing may be considered on a case-by-case basis.

Learn more about this trial

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

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