Zika in Infants and Pregnancy (ZIP)

Study Overview
=================
Brief Summary
-----------------
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.

Detailed Description
-----------------
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study. The study will recruit up to10,000 pregnant women in their first trimester from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.

Official Title
-----------------
International Prospective Observational Cohort Study of Zika in Infants

Conditions
-----------------
Zika Virus Disease (Disorder)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age >15 years Assent and consent as required per local country regulations Confirmation of pregnancy by beta human chorionic gonadotropin (hCG) measurement in blood/urine or ultrasound confirmation of pregnancy with fetal heart tones present Pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. Exclusion Criteria: Pregnant Women Women who cannot adhere to proposed testing schedule Pregnant women enrolled in other research including other ZIKV research Inclusion Criteria (newborn) All infants born to women enrolled in the observational cohort are eligible for enrollment Exclusion Criteria (newborn) Mother or custodial parent does not consent to have child participate Infants born to mothers that are not part of the ZIP cohort study

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ZIKV infected women<br>The study will prospectively enroll pregnant women up to 17 weeks and 6 days gestation and follow them through their pregnancy for clinical evidence of acute ZIKV infection while controlling for potential confounders. All pregnant women will be followed throughout the pregnancy, delivery, and 6 weeks postpartum. Outcomes in women, the developing fetus, and infants will be assessed. | |
| Control (uninfected women)<br>The women who remain uninfected will serve as the internal comparison group. The infants who remain uninfected at delivery and throughout the follow-up period will serve as the internal comparison group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | Time of birth of infant | 
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | 3 months of age | 
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | 6 months of age | 
| Incidence of congenital malformations for ZIKV infected participants | To measure the incidence of congenital malformations in fetuses/infants. | 12 months of age | 
| Incidence of adverse fetal outcomes for ZIKV infected participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants. | Time of birth of infant | 
| Incidence of adverse fetal outcomes for ZIKV infected participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants. | 3 months of age | 
| Incidence of adverse fetal outcomes for ZIKV infected participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants. | 6 months of age | 
| Incidence of adverse fetal outcomes for ZIKV infected participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants. | 12 months of age | 
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | Time of birth of infant | 
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | 3 months of age | 
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | 6 months of age | 
| Incidence of congenital malformations for ZIKV symptomatic participants | To measure the incidence of congenital malformations in fetuses/infants. | 12 months of age | 
| Incidence of adverse fetal outcomes for ZIKV symptomatic participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants. | Time of birth of infant | 
| Incidence of adverse fetal outcomes for ZIKV symptomatic participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants. | 3 months of age | 
| Incidence of adverse fetal outcomes for ZIKV symptomatic participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants. | 6 months of age | 
| Incidence of adverse fetal outcomes for ZIKV symptomatic participants | To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants. | 12 months of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Infant