Clinical Trial: Zika in Infants and Pregnancy (ZIP)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 during the first trimester of pregnancy and follow them 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 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 during the first trimester of pregnancy and follow them 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 10,000 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.

Sponsor: RTI International

Current Primary Outcome:

• Incidence of congenital malformations for ZIKV infected participants [ Time Frame: Time of birth of infant ]
  To measure the incidence of congenital malformations in fetuses/infants.
• Incidence of congenital malformations for ZIKV infected participants [ Time Frame: 3 months of age ]
  To measure the incidence of congenital malformations in fetuses/infants.
• Incidence of congenital malformations for ZIKV infected participants [ Time Frame: 6 months of age ]
  To measure the incidence of congenital malformations in fetuses/infants.
• Incidence of congenital malformations for ZIKV infected participants [ Time Frame: 12 months of age ]
  To measure the incidence of congenital malformations in fetuses/infants.
• Incidence of adverse fetal outcomes for ZIKV infected participants [ Time Frame: Time of birth of infant ]
  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.
• Incidence of adverse fetal outcomes for ZIKV infected participants [ Time Frame: 3 months of age ]
  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.
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  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: RTI International
  

  Dates:
  Date Received: July 20, 2016
  Date Started: June 2016
  Date Completion: June 2018
  Last Updated: April 26, 2017
  Last Verified: April 2017