Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- CMV reinfections in women with non-primary infections
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Laboratory personnel will not know the participant's intervention status.
入排标准
- 年龄范围
- 14 Years 至 39 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
CMV Risk-Reduction Intervention
One-on-one CMV prevention and education visit followed by 12 weeks of CMV prevention and education text messages
干预措施: CMV Risk-Reduction Intervention (Behavioral)
Stress Reduction Messaging
One-on-one stress reduction messaging visit followed by 12 weeks of reducing stress text messages
干预措施: Stress Reduction Messaging (Behavioral)
结局指标
主要结局
CMV reinfections in women with non-primary infections
时间窗: Enrollment(baseline) until delivery, up to 32 weeks
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.
CMV seroconversion rate in CMV seronegative women
时间窗: Enrollment (baseline) until delivery, up to 32 weeks
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.
次要结局
- Change in self-reported CMV risk behaviors and protective behaviors(Enrollment (baseline) to 12 weeks after enrollment (follow-up))
- Frequency of CMV shedding(Enrollment(baseline) until delivery, up to 32 weeks)
- Proportion of infants with congenital CMV(Delivery)
- Frequency of new CMV variants(Enrollment(baseline) until delivery up to 32 weeks)
研究者
Karen Fowler
Primary Investigator
University of Alabama at Birmingham
