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Completed

NCT Number: NCT02741882

Zika and Microcephaly: Case-control Study

It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design.

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Key information

Conditions

Microcephaly Arbovirus Infections Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Flaviviridae Infections Flavivirus Infections Infections Malformations of Cortical Development Malformations of Cortical Development, Group I Mosquito-Borne Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations RNA Virus Infections Vector Borne Diseases Virus Diseases Zika Virus Infection

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sabin laboratory

Brasília, Federal District, 71000-000, Brazil

About this study

The investigators will carry out a case-control study among mothers who delivered their babies at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. Data sources for the phase I of the study will consist of medical records review and a standard questionnaire applied by telephone to collect information about demographic features, clinical signs and symptoms, and the duration and severity of the illness. Phase II will include dengue, chikungunya and dengue serologic test results as secondary outcome, if available. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during pregnancy is related to the microcephaly using the case-control design

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Delivered a baby at nossa senhora de lourdes maternity from September 1, 2015 through january 5, 2016.

Exclusion criteria

  • Syphilis during pregnancy, toxoplasmosis during pregnancy, consanguinity, other genetics disorder, alcohol or abuse drug consumption during pregnancy.

Treatment and study plan

questionary

Other

Questionary with clinical, demographic and behavior outcomes at the pregnancy period

Primary outcomes

  1. Zika virus infection clinical outcomes during pregnancy

    Time frame: From September 1, 2015 through January 5, 2016

    acute onset of generalized rash together with three of the following symptoms: Conjunctivitis, arthralgia, mild-fever or periarticular edema.

Secondary outcomes

  1. zika virus serology

    Time frame: march, 2016 through July 5, 2016

    If available, zika virus serology will be performed

  2. Chikungunya virus serology

    Time frame: march, 2016 through July 5, 2016

    If available, chikungunya virus serology will be performed

  3. Dengue virus serology

    Time frame: march, 2016 through July 5, 2016

    If available, Dengue virus serology will be performed

Sponsors and collaborators

Lead sponsor

Laboratório Sabin

Industry

Registry information

Official study title

Rash Accompanied by Three or More Dengue-like Symptoms During Pregnancy and Microcephaly: Case-control Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 18, 2016
Registry last updated
Feb 23, 2017

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.

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