Clinical trial NCT02741882: Zika and Microcephaly: Case-control Study
Official title: Rash Accompanied by Three or More Dengue-like Symptoms During Pregnancy and Microcephaly: Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcephaly
Keywords: Microcephaly
zika Virus
Case-control study
Lead sponsor: Laboratório Sabin
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 110
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Zika virus infection clinical outcomes during pregnancy
timeFrame: From September 1, 2015 through January 5, 2016
Secondary outcomes:
measure: zika virus serology
timeFrame: march, 2016 through July 5, 2016
measure: Chikungunya virus serology
timeFrame: march, 2016 through July 5, 2016
measure: Dengue virus serology
timeFrame: march, 2016 through July 5, 2016
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Sabin laboratory
state: Distrito Federal
Study officials:
affiliation: Sabin Laboratory
name: Gustavo B Barra, ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.