Clinical Trial of Behavioral Modification to Prevent Congenital Cytomegalovirus

NCT01819519 | Completed DMC

• 1 other identifier: RFA-DD-12-005
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections; Pregnancy; Behavior

Keywords

Intervention studies; Pregnancy; Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• Change in Hygiene Behaviors

  The primary outcome is defined as a change in the participant's hygiene behaviors determined by the differences between the baseline and follow-up behavioral assessment compliance scores. Each question in these assessments will be assigned a score from 0-5 (5 = desired preventative behavior).

  Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

Secondary Outcomes (6)

• Behavior Change based on Serostatus

  Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

• Change in K10 after Intervention

  Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

• Behavior Change based on Socioeconomics

  Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

• Racial associations with hygiene behavior change

  Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

• Behavior Change related to Children at home

  Participants will be followed from enrollment (baseline) to 14-20 weeks after enrollment (follow-up)

Study Arms (2)

Standard Prenatal Care

NO INTERVENTION

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

Educational Intervention

EXPERIMENTAL

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).

Behavioral: Educational Intervention

Interventions

Educational Intervention 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.

Educational Intervention

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• 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.

  PMID: 28885428 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections; Behavior

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Brenna Anderson, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 27, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)