Clinical Trial: Zika and Microcephaly: Case-control Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary: 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
Sponsor: Laboratório Sabin

Current Primary Outcome: 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.


Original Primary Outcome: Zika virus infection clinical outcomes during pregnancy [ Time Frame: From September 1, 2015 through January 5, 2016 ]

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


Current Secondary Outcome:

  • zika virus serology [ Time Frame: march, 2016 through July 5, 2016 ]
    If available, zika virus serology will be performed
  • Chikungunya virus serology [ Time Frame: march, 2016 through July 5, 2016 ]
    If available, chikungunya virus serology will be performed
  • Dengue virus serology [ Time Frame: march, 2016 through July 5, 2016 ]
    If available, Dengue virus serology will be performed


Original Secondary Outcome: Same as current

Information By: Laboratório Sabin

Dates:
Date Received: April 13, 2016
Date Started: February 2016
Date Completion:
Last Updated: February 18, 2017
Last Verified: February 2017