Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: The ZIKAlliance consortium

Background: The European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic. Methods: Recruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1-3, 4-6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmissio

Incidencia de anticuerpos antifosfolípidos en mujeres embarazadas sanas y en mujeres con abortos espontáneos, atendidas en la consulta de ginecología y obstetricia de la Ciudad Hospitalaria Dr. Enrique Tejera. Valencia. Carabobo. 2006

Los anticuerpos antifosfolípidos son una familia heterogénea de inmunoglobulinas que se unen a los fosfolípidos cargados negativamente presentes en las membranas celulares. Los anticuerpos anticardiolipinas y los anticoagulantes lúpicos son los principales representantes de esta familia de autoanticuerpos, que están siendo relacionados con complicaciones obstétricas, principalmente abortos espontáneos a repetición. Se determinó la incidencia de estos autoanticuerpos en mujeres con embarazos normales y en mujeres con más de 2 abortos a repetición; para ello se realizaron determinaciones séricas de los isotipos M y G de las inmunoglobulinas para anticuerpos anticardiolipinas (ACA) y para anti beta2glicoproteina I (antiß2GPI) utilizando la metodología ELISA. Los resultados obtenidos muestran 11,1% de las mujeres con embarazos normales dieron resultados positivos para la IgM ACA, mientras que en las mujeres con abortos espontáneos a repetición el porcentaje de positividad fue de 23%. En cuanto al isotipo IgG ACA se obtuvo 15% de positividad en las mujeres con embarazos normales contra 57% de positividad en las mujeres con abortos (p<0,01). Cuando se evaluó el isotipo IgM de la antiß2GPI la positividad observada fue de 1% en las mujeres con embarazos normales contra 43% de positividad en mujeres con abortos (p<0,01). En cuanto a los porcentajes de positividad para el isotipo IgG de la antiß2GPI fue de 20% para las mujeres con embarazos normales y de 9% en las mujeres con abortos. Se concluye que IgG ACA e IgM antiß2GPI pueden estar asociadas a interrupción espontánea del embarazo

Zika virus infection in pregnancy : a protocol for the joint analysis of the prospective cohort studies of the ZIKAlliance, ZikaPLAN and ZIKAction consortia

Introduction: Zika virus (ZIKV) infection in pregnancy has been associated with microcephaly and severe neurological damage to the fetus. Our aim is to document the risks of adverse pregnancy and birth outcomes and the prevalence of laboratory markers of congenital infection in deliveries to women experiencing ZIKV infection during pregnancy, using data from European Commission-funded prospective cohort studies in 20 centres in 11 countries across Latin America and the Caribbean. Methods and analysis: We will carry out a centre-by-centre analysis of the risks of adverse pregnancy and birth outcomes, comparing women with confirmed and suspected ZIKV infection in pregnancy to those with no evidence of infection in pregnancy. We will document the proportion of deliveries in which laboratory markers of congenital infection were present. Finally, we will investigate the associations of trimester of maternal infection in pregnancy, presence or absence of maternal symptoms of acute ZIKV infection and previous flavivirus infections with adverse outcomes and with markers of congenital infection. Centre-specific estimates will be pooled using a two-stage approach. Ethics and dissemination: Ethical approval was obtained at each centre. Findings will be presented at international conferences and published in peer-reviewed open access journals and discussed with local public health officials and representatives of the national Ministries of Health, Pan American Health Organization and WHO involved with ZIKV prevention and control activities