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NIH to study 10,000 pregnant women in Zika-affected areas

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The NIH and Fundação Oswaldo Cruz-Fiocruz, a national research organization associated with the Brazilian Ministry of Health, have initiated a multinational study to evaluate Zika’s health risks for pregnant women and their developing fetuses.

“The full scope of the effect of Zika virus in pregnancy has not yet been fully determined,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. “This large prospective study promises to provide important new data that will help guide the medical and public health responses to the Zika virus epidemic.”

Anthony S. Fauci

The Zika in Infants and Pregnancy (ZIP) study will commence in Puerto Rico and expand to Brazil and Colombia, the release said. It will enroll up to 10,000 pregnant women in their first trimester aged 15 years and older. Each mother will be monitored monthly for the duration of their pregnancy and then once more 6 weeks after delivery. At each evaluation, blood, urine, saliva and vaginal swab samples will be taken from each participant. If the mother notes that she will be receiving an amniocentesis, amniotic fluid will be tested for Zika. All will be instructed about the signs and symptoms of Zika so they can report immediately if they experience symptoms. After delivery, a breast milk sample, if available, will be obtained to test for Zika. Upon maternal consent, infants will be evaluated within 48 hours after birth and at 3, 6 and 12 months.

According to the release, frequency of miscarriage, preterm birth, microcephaly and malformations of the nervous system will be compared between mothers infected with Zika and those not infected. This comparison also will be made for symptomatic and asymptomatic mothers with Zika.

“This study, in partnership with NIH, is essential to elucidating the scientific complexity of the Zika virus,” Paulo Gadelha, MD, PhD, president of Fiocruz, said in the release. “It will be fundamental to developing prevention and treatment strategies against the disease.”