Skip to main content
OpenTrials
Completed

NCT Number: NCT02856984

Zika in Infants and Pregnancy (ZIP)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Zika Virus Disease (Disorder) Arbovirus Infections Flaviviridae Infections Flavivirus Infections Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases Zika Virus Infection

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao, Salvador, Estado de Bahia, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Incidence of congenital malformations for ZIKV infected participants

    Time frame: 3 months of age

    To measure the incidence of congenital malformations in fetuses/infants.

  3. Incidence of congenital malformations for ZIKV infected participants

    Time frame: 6 months of age

    To measure the incidence of congenital malformations in fetuses/infants.

  4. Incidence of congenital malformations for ZIKV infected participants

    Time frame: 12 months of age

    To measure the incidence of congenital malformations in fetuses/infants.

  5. 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.

  6. 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.

  7. Incidence of adverse fetal outcomes for ZIKV infected participants

    Time frame: 6 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.

  8. Incidence of adverse fetal outcomes for ZIKV infected participants

    Time frame: 12 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.

  9. Incidence of congenital malformations for ZIKV symptomatic participants

    Time frame: Time of birth of infant

    To measure the incidence of congenital malformations in fetuses/infants.

  10. Incidence of congenital malformations for ZIKV symptomatic participants

    Time frame: 3 months of age

    To measure the incidence of congenital malformations in fetuses/infants.

  11. Incidence of congenital malformations for ZIKV symptomatic participants

    Time frame: 6 months of age

    To measure the incidence of congenital malformations in fetuses/infants.

  12. Incidence of congenital malformations for ZIKV symptomatic participants

    Time frame: 12 months of age

    To measure the incidence of congenital malformations in fetuses/infants.

  13. Incidence of adverse fetal outcomes for ZIKV symptomatic participants

    Time frame: Time of birth of infant

    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  14. Incidence of adverse fetal outcomes for ZIKV symptomatic participants

    Time frame: 3 months of age

    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  15. Incidence of adverse fetal outcomes for ZIKV symptomatic participants

    Time frame: 6 months of age

    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  16. Incidence of adverse fetal outcomes for ZIKV symptomatic participants

    Time frame: 12 months of age

    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Environmental Health Sciences (NIEHS)
  • Oswaldo Cruz Foundation

Registry information

Official study title

International Prospective Observational Cohort Study of Zika in Infants

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2016
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.