Zika and Microcephaly: Case-control Study

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

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.

Study Overview

• Status: Completed
• Conditions: Microcephaly
• Intervention / Treatment: Other: Questionary

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
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 71000-000
      • Sabin laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: Questionary; Questionary with clinical, demographic and behavior outcomes at the pregnancy period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
zika virus serology	If available, zika virus serology will be performed	march, 2016 through July 5, 2016
Chikungunya virus serology	If available, chikungunya virus serology will be performed	march, 2016 through July 5, 2016
Dengue virus serology	If available, Dengue virus serology will be performed	march, 2016 through July 5, 2016

Collaborators and Investigators

• Sponsor: Laboratório Sabin
• Investigators: Principal Investigator: Gustavo B Barra, ph.D, Sabin laboratory

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 18, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Microcephaly; zika Virus; Case-control study
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Microcephaly
• Other Study ID Numbers: Zika and microcephaly

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No