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Zika and Microcephaly: Case-control Study

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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

Tracking Information
First Submitted Date April 13, 2016
First Posted Date April 18, 2016
Last Update Posted Date February 23, 2017
Study Start Date February 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2016)
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 Measures
 (submitted: April 15, 2016)
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.
Change History Complete list of historical versions of study NCT02741882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 15, 2016)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Zika and Microcephaly: Case-control Study
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 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Microcephaly
Intervention Other: Questionary
Questionary with clinical, demographic and behavior outcomes at the pregnancy period
Study Groups/Cohorts
  • 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.
    Intervention: Other: Questionary
  • 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.
    Intervention: Other: Questionary
Publications * Santa Rita TH, Barra RB, Peixoto GP, Mesquita PG, Barra GB. Association between suspected Zika virus disease during pregnancy and giving birth to a newborn with congenital microcephaly: a matched case-control study. BMC Res Notes. 2017 Sep 6;10(1):457. doi: 10.1186/s13104-017-2796-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2017)
110
Original Estimated Enrollment
 (submitted: April 15, 2016)
90
Actual Study Completion Date February 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT02741882
Other Study ID Numbers Zika and microcephaly
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gustavo Barcelos Barra, Laboratório Sabin
Study Sponsor Laboratório Sabin
Collaborators Not Provided
Investigators
Principal Investigator: Gustavo B Barra, ph.D Sabin Laboratory
PRS Account Laboratório Sabin
Verification Date February 2017