An observational study in Microcephaly, sponsored by Laboratório Sabin. Completed at 1 site in Brazil. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Laboratório Sabin · Observational
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.
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
22 studies on the registry are indexed under Microcephaly; 5 are open to participants now.
This study's enrollment of 110 is below the median of 232 across 16 observational studies indexed under Microcephaly.
Browse Microcephaly studies →This is the only study on the registry with Laboratório Sabin as lead sponsor.
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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.
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Exclusion Criteria:
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
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
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.
Time frame: From September 1, 2015 through January 5, 2016
zika virus serology
If available, zika virus serology will be performed
Time frame: march, 2016 through July 5, 2016
Chikungunya virus serology
If available, chikungunya virus serology will be performed
Time frame: march, 2016 through July 5, 2016
Dengue virus serology
If available, Dengue virus serology will be performed
Time frame: march, 2016 through July 5, 2016
Plan to share: No
The record gives a start of Feb 2016, a primary completion of Aug 2016 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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