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International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.

ABSTRACT: BACKGROUND:Until recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, the nature and extent of the relationship between ZIKV and adverse pregnancy and pediatric health outcomes is not well understood. With the unique opportunity to prospectively explore the full spectrum of issues related to ZIKV exposure during pregnancy, we undertook a multi-country, prospective cohort study to evaluate the association between ZIKV and pregnancy, neonatal, and infant outcomes. METHODS:At research sites in ZIKV endemic regions of Brazil (4 sites), Colombia, Guatemala, Nicaragua, Puerto Rico (2 sites), and Peru, up to 10,000 pregnant women will be recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6?weeks post-partum; their infants will be followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV will also be enrolled, regardless of gestational age. Participants will be tested monthly for ZIKV infection; additional demographic, physical, laboratory and environmental data will be collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, will be obtained. DISCUSSION:With the emergence of ZIKV in the Americas and its association with adverse pregnancy outcomes in this region, a much better understanding of the spectrum of clinical outcomes associated with exposure to ZIKV during pregnancy is needed. This cohort study will provide information about maternal, fetal, and infant outcomes related to ZIKV infection, including congenital ZIKV syndrome, and manifestations that are not detectable at birth but may appear during the first year of life. In addition, the flexibility of the study design has provided an opportunity to modify study parameters in real time to provide rigorous research data to answer the most critical questions about the impact of congenital ZIKV exposure. TRIAL REGISTRATION:NCT02856984 . Registered August 5, 2016. Retrospectively registered.

SUBMITTER: Lebov JF

PROVIDER: S-EPMC6686399 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.

Lebov Jill F JF Arias Juan F JF Balmaseda Angel A Britt William W Cordero José F JF Galvão Luiz Augusto LA Garces Ana Lucía AL Hambidge K Michael KM Harris Eva E Ko Albert A Krebs Nancy N Marques Ernesto T A ETA Martinez Alexander M AM McClure Elizabeth E Miranda-Filho Democrito B DB Moreira Maria Elisabeth Lopes MEL Mussi-Pinhata Marisa M MM Ochoa Theresa J TJ Osorio Jorge E JE Scalabrin Deolinda M F DMF Schultz-Cherry Stacey S Seage George R GR Stolka Kristen K Ugarte-Gil César Augusto CA Vega Carmen Milagros Velez CMV Welton Michael M Ximenes Ricardo R Zorrilla Carmen C

BMC pregnancy and childbirth 20190807 1

<h4>Background</h4>Until recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, the nature and extent of the relationship between ZIKV and adverse pregnancy and pediatric health outcomes is not well understood. With the unique opportunity to prospectively explore the full spectrum ...[more]

PMID: 31391005

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Project description:Zika virus (ZIKV) infection may adversely affect pregnancies of women living with HIV (WLHIV). Because no study to date has focused on maternal and child effects of HIV and ZIKV co-infection in pregnant women, we undertook the International Prospective Cohort Study of HIV and Zika in Infants and Pregnancy (HIV ZIP). The aims of this two-phase study of pregnant women and their infants are to compare the incidence of ZIKV infection among pregnant women with and without HIV infection and to determine the risk of adverse maternal and child outcomes associated with ZIKV/HIV co-infection at clinical sites in Brazil, Puerto Rico, and the continental United States. Phase I was designed to enroll pregnant women/infant pairs who were: (1) infected with HIV only, (2) infected with ZIKV only, (3) infected with HIV and ZIKV, and (4) not infected with either HIV or ZIKV. A key goal of this phase was to assess the feasibility of enrolling 200 women/infant pairs within a year, with a target of 150 WLHIV, 50 HIV-uninfected women, and a minimum of 20 who were co-infected with HIV and ZIKV. If the feasibility of Phase I proved successful, Phase II would enroll up to 1,800 additional pregnant women/infant pairs to the same four groups. Enrolled women in both phases were to be followed throughout their pregnancy and up to 6 weeks post-partum. Infants were also to be followed for 1 year after birth. To date, Phase 1 data collection and follow-up have been completed. Delineation of possible harmful effects of HIV/ZIKV co-infection will allow the formulation of standard-of-care recommendations to minimize adverse effects but enable the continuation of preventive HIV therapy. Furthermore, while the prospective HIV ZIP study was developed before the COVID pandemic, it is especially relevant today since it can be easily adapted to provide critically important information on the impact of COVID-19 infection or other still unrecognized new agents among pregnant women and their offspring worldwide.

Project description:BackgroundPostoperative hypotension is common after major non-cardiac surgery, due predominantly to vasodilation. Administration of infused vasopressors postoperatively may often be considered a surrogate indicator of vasodilation. The incidence of postoperative vasopressors has never been described for non-cardiac surgery, nor have outcomes associated with their use. This paper presents a protocol for a prospective international cohort study to address these gaps in knowledge. The primary objectives are to estimate the proportion of patients who receive postoperative vasopressor infusions (PVI) and to document the variation in this proportion between hospitals and internationally. Furthermore, we will identify factors in variation of care (patient, condition, surgery, and intraoperative management) associated with receipt of PVI and investigate how PVI use is associated with patient outcomes, including organ dysfunction, length of hospital stay, and 30-day in-hospital mortality.MethodThis will be a prospective, international, multicentre cohort study that includes all adult (≥ 18 years) non-cardiac surgical patients in participating centres. Patients undergoing cardiac, obstetric, or day-case surgery will be excluded. We will recruit two cohorts of patients: cohort A will include all eligible patients admitted to participating hospitals for seven consecutive days. Cohort B will include 30 sequential patients per hospital, with the single additional inclusion criterion of postoperative vasopressor usage. We expect to collect data on approximately 40,000 patients for cohort A and 12,800 patients for cohort B.DiscussionWhile in cardiac surgery, clinical trials have informed the choice of vasopressors used to treat postoperative vasoplegia; there remains equipoise over the best approach in non-cardiac surgery. Our study will represent the first large-scale assessment of the use of vasopressors after non-cardiac surgery. These data will inform future studies, including trials of different vasopressors and potential management options to improve outcomes and reduce resource use after surgery.Trial registrationClinicalTrials.gov Identifier: NCT03805230, 15 January 2019.

Project description:IntroductionAssisted reproductive technologies (ART), namely in vitro fertilisation and intracytoplasmic sperm injection, have become widely used to treat infertility. Although the use of ART is generally considered favourable, there are ongoing concerns about the prenatal and perinatal risks as well as long-term risks for the child. Epidemiological studies have demonstrated an association between pathological events during fetal development and future cardiovascular risk, raising concerns about cardiovascular remodelling in fetuses conceived by ART. The authors hypothesise fetuses conceived by ART present signs of cardioventricular dysfunction, which can be detected by deformation analysis. To address these issues, we will assess comprehensive cardiovascular structure and function in ART offspring and explore the role of speckle-tracking in myocardial deformation.Methods and analysisThis prospective observational cohort study will include 100 singleton pregnancies conceived by ART and 100 controls identified in fetal life and followed up to 6 months old. At inclusion, a baseline assessment of the mothers and ART characteristics will be recorded by interview and review of medical records. Between 28 and 32 weeks gestation, a detailed fetal echography will be performed, including an assessment of estimated fetal weight, fetoplacental Doppler, fetal echocardiography and fetal abdominal artery ultrasound. On delivery, maternal and neonatal characteristics will be assessed. Within 60 days of birth, the first postnatal cardiovascular assessment will be conducted which will include echocardiography and abdominal artery ultrasound. At 6 months of age, the second infants' follow-up evaluation will include the weight and length of the infant, echocardiography and abdominal artery ultrasound. Data will be presented as mean±SD, median or percentages where appropriate. A p<0.05 will be considered statistically significant.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Shengjing Hospital of China Medical University. Findings will be disseminated through scientific publications and conference presentations.Trial registration numberChiCTR1900021672.

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International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.

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International prospective observational cohort study of Zika in infants and pregnancy (ZIP study): study protocol.

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