Zika and Microcephaly: Case-control Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Microcephaly

Intervention / Treatment
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* Other: Questionary


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Mothers who delivered a baby with microcephaly at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. The intervention will be a questionary. | Other: Questionary<br>* Questionary with clinical, demographic and behavior outcomes at the pregnancy period<br>|
| Controls<br>Mothers who delivered a baby without microcephaly at Nossa Senhora de Lourdes maternity hospital located in Aracaju, state of Sergipe, Brazil from September 1, 2015 through January 5, 2016. The intervention will be a questionary. | Other: Questionary<br>* Questionary with clinical, demographic and behavior outcomes at the pregnancy period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zika virus infection clinical outcomes during pregnancy | acute onset of generalized rash together with three of the following symptoms: Conjunctivitis, arthralgia, mild-fever or periarticular edema. | From September 1, 2015 through January 5, 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| zika virus serology | If available, zika virus serology will be performed | march, 2016 through July 5, 2016 | 
| Chikungunya virus serology | If available, chikungunya virus serology will be performed | march, 2016 through July 5, 2016 | 
| Dengue virus serology | If available, Dengue virus serology will be performed | march, 2016 through July 5, 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microcephaly, zika Virus, Case-control study