Zika and Microcephaly: Case-control Study

Microcephaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741882
• Other study ID #: Zika and microcephaly
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: February 18, 2017
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Laboratório Sabin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Microcephaly

Intervention

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

Locations

Country	Name	City	State
Brazil	Sabin laboratory	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Laboratório Sabin

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	zika virus serology	If available, zika virus serology will be performed	march, 2016 through July 5, 2016
Secondary	Chikungunya virus serology	If available, chikungunya virus serology will be performed	march, 2016 through July 5, 2016
Secondary	Dengue virus serology	If available, Dengue virus serology will be performed	march, 2016 through July 5, 2016