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Zika and Microcephaly: Case-control Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02741882
Enrollment
110
Registered
2016-04-18
Start date
2016-02-29
Completion date
2017-02-28
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcephaly

Keywords

Microcephaly, zika Virus, 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

Interventions

OTHERQuestionary

Questionary with clinical, demographic and behavior outcomes at the pregnancy period

Sponsors

Laboratório Sabin
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Zika virus infection clinical outcomes during pregnancyFrom September 1, 2015 through January 5, 2016acute onset of generalized rash together with three of the following symptoms: Conjunctivitis, arthralgia, mild-fever or periarticular edema.

Secondary

MeasureTime frameDescription
zika virus serologymarch, 2016 through July 5, 2016If available, zika virus serology will be performed
Chikungunya virus serologymarch, 2016 through July 5, 2016If available, chikungunya virus serology will be performed
Dengue virus serologymarch, 2016 through July 5, 2016If available, Dengue virus serology will be performed

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026