跳至主要内容
临床试验/NCT04615715
NCT04615715已完成不适用

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

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 582 人开始时间: 2021年1月11日最近更新:
适应症
干预措施

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

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Fowler

Primary Investigator

University of Alabama at Birmingham

研究点 (1)

Loading locations...

相似试验

进行中(未招募)
不适用
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell TransplantHematopoietic/Lymphoid CancerAccelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-cell LymphomaAngioimmunoblastic T-cell LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL NegativeBlastic Phase Chronic Myelogenous LeukemiaChronic Eosinophilic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous LeukemiaContiguous Stage II Adult Burkitt LymphomaContiguous Stage II Adult Diffuse Large Cell LymphomaAnaplastic Large Cell LymphomaContiguous Stage II Adult Diffuse Mixed Cell LymphomaContiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaContiguous Stage II Adult Immunoblastic Large Cell LymphomaContiguous Stage II Adult Lymphoblastic LymphomaContiguous Stage II Grade 1 Follicular LymphomaContiguous Stage II Grade 2 Follicular LymphomaContiguous Stage II Grade 3 Follicular LymphomaContiguous Stage II Mantle Cell LymphomaContiguous Stage II Marginal Zone LymphomaContiguous Stage II Small Lymphocytic LymphomaCutaneous B-cell Non-Hodgkin Lymphomade Novo Myelodysplastic SyndromesExtramedullary PlasmacytomaEssential ThrombocythemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueIntraocular LymphomaIsolated Plasmacytoma of BoneMeningeal Chronic Myelogenous LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPreviously Treated Myelodysplastic SyndromesPrimary Systemic AmyloidosisProgressive Hairy Cell Leukemia, Initial TreatmentPrimary MyelofibrosisPost-transplant Lymphoproliferative DisorderRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesSplenic Marginal Zone LymphomaStage 0 Chronic Lymphocytic LeukemiaStage I Adult Burkitt LymphomaStage I Adult Diffuse Large Cell LymphomaStage I Adult Diffuse Mixed Cell LymphomaStage I Adult Diffuse Small Cleaved Cell LymphomaStage I Adult Hodgkin LymphomaStage I Adult Immunoblastic Large Cell LymphomaStage I Adult Lymphoblastic LymphomaStage I Adult T-cell Leukemia/LymphomaStage I Chronic Lymphocytic LeukemiaStage I Cutaneous T-cell Non-Hodgkin LymphomaStage I Grade 1 Follicular LymphomaStage I Grade 2 Follicular LymphomaStage I Grade 3 Follicular LymphomaStage I Mantle Cell LymphomaStage I Marginal Zone LymphomaStage I Multiple MyelomaStage I Mycosis Fungoides/Sezary SyndromeStage I Small Lymphocytic LymphomaStage II Adult Hodgkin LymphomaStage II Adult T-cell Leukemia/LymphomaStage II Chronic Lymphocytic LeukemiaStage II Cutaneous T-cell Non-Hodgkin LymphomaStage II Multiple MyelomaStage II Mycosis Fungoides/Sezary SyndromeStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Adult T-cell Leukemia/LymphomaStage III Chronic Lymphocytic LeukemiaStage III Cutaneous T-cell Non-Hodgkin LymphomaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Multiple MyelomaStage III Mycosis Fungoides/Sezary SyndromeStage III Small Lymphocytic LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult T-cell Leukemia/LymphomaStage IV Chronic Lymphocytic LeukemiaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic LymphomaT-cell Large Granular Lymphocyte LeukemiaWaldenstrom MacroglobulinemiaChronic Myelomonocytic LeukemiaAplastic AnemiaPolycythemia VeraProlymphocytic LeukemiaCytomegalovirus InfectionSecondary MyelofibrosisAcute Undifferentiated LeukemiaMast Cell Leukemia
NCT01199562City of Hope Medical Center153
已完成
4 期
CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")Cytomegalovirus Infection
NCT01552369National Institute of Allergy and Infectious Diseases (NIAID)205
已完成
2 期
Cytomegalovirus Control in Critical CareCritical Illness
NCT01503918University Hospital Birmingham NHS Foundation Trust124
招募中
3 期
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus ValaciclovirPregnant WomenCMV Infected Fetuses
NCT05446571Assistance Publique - Hôpitaux de Paris46
Unknown
不适用
Primary Prevention of Cytomegalovirus in Pregnancy: Addressing the Gaps (CMV GAP)Cytomegalovirus Congenital
NCT04879784University Hospital Southampton NHS Foundation Trust6,000