Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

NCT ID: NCT01819519

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this study is to develop a brief screening and behavioral intervention for the prevention of congenital cytomegalovirus (CMV) that will both be acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care, and to test whether behavioral intervention for susceptible pregnant women can lead to a behavioral change that is likely to lead to decreased primary CMV infection. The study research assistants will enroll pregnant women who are less than 20 weeks' gestation, either English or Spanish-speaking and that do not have a primary CMV infection (never been infected or previously infected). Enrollment will occur during the woman's prenatal visit.

Detailed Description

The study is a randomized single-masked clinical trial of behavioral intervention versus standard care of pregnant women lacking evidence of acute CMV infection that have consented to be screened as part of the Maternal Fetal Medicine Units Network multi-centered randomized clinical trial, in which pregnant women are screened with CMV serology for IgM, IgG, and IgG avidity.

Eligible pregnant women will be randomized to one of two treatment groups:

• Control Group - no intervention
• Intervention Group - brief intervention and educational materials Written informed consent will be obtained from patients before they can be screened for the study by CMV testing (IgM, IgG, and IgG avidity) as per the protocol for screening in the MFMU study.

All women presenting for prenatal care no later than 20 weeks gestational age without a known multifetal gestation are eligible for CMV screening Those with evidence of primary infection will be offered participation in the MFMU randomized trial of CMV hyperimmune globulin to prevent congenital infection. Women lacking evidence of acute infection will be eligible for randomization into this study. Patients must be randomized no later than 20 weeks gestation.

If eligible and no more than 20 weeks gestation, the patient will be randomized. If the patient is randomized in the control group, she will continue her routine prenatal care inclusive of the CDC brochure that she received at the time of her venipuncture for serologic screening and assessment of hygiene behaviors. If the patient is randomized into the intervention group, we will deliver a face-face educational intervention during her next routine prenatal visit. In addition to the intervention, the patient will include educational material to take home.

Both groups will be assessed for performance of hygiene behaviors as a baseline assessment at the time of consent. A second assessment will occur at least 12 weeks after enrollment during the third trimester between 28-36 weeks of gestation. The follow-up assessment will be completed by a different research assistant from the unblinded educator. A Kessler 10 (K10) survey will also be completed in addition to the baseline and follow-up assessment.

The follow-up assessment will take place during the participant's third trimester between 28-36 weeks of gestation, depending on duration of enrollment and likelihood of early delivery. The enrollment duration will vary from approximately 14-20 weeks.

Conditions

Cytomegalovirus Infections; Pregnancy; Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard Prenatal Care

Participants will receive standard prenatal care from the time they are screened for CMV to delivery. This includes a CMV brochure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Educational Intervention

This group will be approached during a routine prenatal visit and will receive a 5-10 minute educational intervention (CMV prevention video, preventive information, weekly text messages/emails as reminders for hygiene behaviors, developmental calendar with hygiene reminders).

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: BEHAVIORAL

The patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q\&A.

Interventions

Educational Intervention

The patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q\&A.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant women lacking evidence of acute CMV infection is defined as one of the following: A negative IgM antibody (<1.00 Index) and negative IgG antibody (<6.0 AU/ml) or A negative IgM antibody (<1.00 Index) and positive IgG antibody (≥6.0 AU/ml)
• Gestational age during CMV screening will be no later than 20 weeks based on clinical information and evaluation of the earliest ultrasound.
• Enrollment will occur no later than 20 weeks' gestation.
• Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 20 weeks' by project gestational age is acceptable.
• English and Spanish-speaking women of any age will be offered enrollment

Exclusion Criteria

• Planned termination of pregnancy
• Women with a previous child with congenital CMV
• Intention of leaving the prenatal practice
• Known major fetal anomalies or demise
• Multiple gestation
• Known HIV infection
• Primary CMV infection, as determined by a positive IgM antibody, a positive IgG antibody and low IgG avidity or positive IgM antibody and negative IgG antibody
• An old and a recent CMV infection, as determined by a positive IgM antibody, positive IgG antibody and high IgG avidity.
• Non-Spanish or English speaking

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Brenna Hughes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brenna Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Women & Infants Hospital

Locations

Women and Infants Hospital

Providence, Rhode Island, United States

Countries

United States

References

Hughes BL, Gans KM, Raker C, Hipolito ER, Rouse DJ. A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial. Obstet Gynecol. 2017 Oct;130(4):726-734. doi: 10.1097/AOG.0000000000002216.

Reference Type: DERIVED

PMID: 28885428 (View on PubMed)

Other Identifiers

RFA-DD-12-005

Identifier Type: -

Identifier Source: org_study_id