An observational study in Microcephaly and Mental Retardation, sponsored by Universidad Industrial de Santander. Completed at 1 site in Colombia. Open to female participants aged 13 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by Universidad Industrial de Santander · Observational
This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according to trimester of infection and as exposed and unexposed to ZIKV.
Infection with Zika Virus (ZIKV) is an emerging disease in South America and a serious public health problem due to a high prevalence of one of the vectors that transmit the virus, Aedes Aegypti, and the severe and sometimes fatal complications that can be generated in the fetus of women infected by the virus during their pregnancy. Retrospective studies have shown an association with microcephaly, cerebral calcifications, dysgenesis of the corpus callosum, and other anomalies of the central nervous system (CNS). The high risk of neurodevelopmental impairment in the exposed newborn is a major concern.
The epidemiologic and neurobiological evidence supporting the link between infection of pregnant women, trimester of infection, and the development of such anomalies in the fetus is growing to the extent that the Center for Disease Control has officially made a statement supporting this association. Although the dimension of the public health impact is still unknown, limited prospective data makes counseling of pregnant women difficult, especially when they are considering termination of pregnancy.
Given that evidence supporting the neurotropic quality of ZIKV and the potential variations of the effect the virus may have on the developing fetal brain according to the gestational age of infection, we have designed a prospective cohort study to determine whether exposure of the fetus to ZIKV in symptomatic mothers results in fetal CNS anomalies and/or impaired neurodevelopmental outcome of the newborn. As a secondary aim we will determine the effect gestational age has on severity of CNS anomalies and neurodevelopmental outcome.
22 studies on the registry are indexed under Microcephaly; 5 are open to participants now.
This study's enrollment of 284 is above the median of 232 across 16 observational studies indexed under Microcephaly.
Browse Microcephaly studies →Universidad Industrial de Santander is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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ZIKV symptomatic and asymptomatic pregnant women in hyper endemic areas of ZIKV in Colombia
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Pregnant women who on their first prenatal visit (independent of gestational age) confirm through a pre-designed questionnaire that they have had any symptom(s) compatible with ZIKV infection (rash [exanthema or sprout], conjunctivitis, arthralgia or myalgia, fever). Pregnant women with an affirmative response will be categorized in two groups:
Exclusion Criteria:
Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
Other: Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
Asymptomatic pregnant women with a negative RT-PCR ZIKV in serum and urine, and a negative specific serology for ZIKV at enrollment into the study and at the time of delivery
Neurodevelopmental Outcome
Bayley Scales of Infant and Toddler Development Third Edition
Time frame: 24 months corrected age
Fetal CNS Impairment
Prenatal Level III Ultrasound Identification of Fetal CNS Abnormalities
Time frame: Until Birth
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Universidad Industrial de Santander