Zika and Microcephaly: Case-control Study

NCT ID: NCT02741882

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-28

Brief Summary

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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

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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

Conditions

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Microcephaly

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Questionary

Intervention Type OTHER

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

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.

Questionary

Intervention Type OTHER

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

Interventions

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Questionary

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratório Sabin

INDUSTRY

Sponsor Role lead

Responsible Party

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Gustavo Barcelos Barra

Pharm.D Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustavo B Barra, ph.D

Role: PRINCIPAL_INVESTIGATOR

Sabin Laboratory

Locations

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Sabin laboratory

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 28877754 (View on PubMed)

Other Identifiers

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Zika and microcephaly

Identifier Type: -

Identifier Source: org_study_id

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