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Zika and Microcephaly: Case-control Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02741882
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Gustavo Barcelos Barra, Laboratório Sabin

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Microcephaly Other: Questionary

Detailed Description:
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
Study Design
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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Rash Accompanied by Three or More Dengue-like Symptoms During Pregnancy and Microcephaly: Case-control Study
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cases
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
Questionary with clinical, demographic and behavior outcomes at the pregnancy period
Controls
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
Questionary with clinical, demographic and behavior outcomes at the pregnancy period


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741882


Locations
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Brazil
Sabin laboratory
Brasilia, Distrito Federal, Brazil, 71000-000
Sponsors and Collaborators
Laboratório Sabin
Investigators
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Principal Investigator: Gustavo B Barra, ph.D Sabin Laboratory
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gustavo Barcelos Barra, Pharm.D Ph.D, Laboratório Sabin
ClinicalTrials.gov Identifier: NCT02741882    
Other Study ID Numbers: Zika and microcephaly
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gustavo Barcelos Barra, Laboratório Sabin:
Microcephaly
zika Virus
Case-control study
Additional relevant MeSH terms:
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Microcephaly
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Malformations of Cortical Development, Group I
 Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities