Zika and Microcephaly: Case-control Study

Completed

• Conditions: Microcephaly
• Interventions: Other: Questionary

• Registration Number: NCT02741882
• Lead Sponsor: Laboratório Sabin

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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-18
• Primary Completion: 2016-08
• Status Verified: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-18
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Questionary	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.
Controls	Questionary	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dengue virus serology	march, 2016 through July 5, 2016	If available, Dengue virus serology will be performed
zika virus serology	march, 2016 through July 5, 2016	If available, zika virus serology will be performed
Chikungunya virus serology	march, 2016 through July 5, 2016	If available, chikungunya virus serology will be performed

Trial Locations

Locations (1)

Sabin laboratory; 🇧🇷 Brasilia, Distrito Federal, Brazil