Zika and Microcephaly: Case-control Study

NCT02741882 | Completed

• 1 other identifier: Zika and microcephaly
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcephaly

Keywords

Microcephaly; zika Virus; Case-control study

Outcome Measures

Primary Outcomes (1)

• Zika virus infection clinical outcomes during pregnancy

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

  From September 1, 2015 through January 5, 2016

Secondary Outcomes (3)

• zika virus serology

  march, 2016 through July 5, 2016

• Chikungunya virus serology

  march, 2016 through July 5, 2016

• Dengue virus serology

  march, 2016 through July 5, 2016

Study Arms (2)

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.

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.

Other: Questionary

Interventions

Questionary OTHER

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

Cases; Controls

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Delivered a baby at nossa senhora de lourdes maternity from September 1, 2015 through january 5, 2016.

You may not qualify if:

• Syphilis during pregnancy, toxoplasmosis during pregnancy, consanguinity, other genetics disorder, alcohol or abuse drug consumption during pregnancy.

Sponsors & Collaborators

• Laboratório Sabin: lead

Study Sites (1)

Sabin laboratory

Brasília, Federal District, 71000-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28877754 DERIVED

MeSH Terms

Conditions

Microcephaly; Zika Virus Infection

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Gustavo B Barra, ph.D

  Sabin Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm.D Ph.D

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)