The Jundiaí Zika cohort, summary of health, medical and laboratory data collected from women and their children
Phase | Measurements |
Pregnant women at enrolment | Baseline questionnaire - sociodemographic details, past medical history, family history, past obstetric history (parity, miscarriages, mode of delivery, malformations), current obstetric history (if pregnancy was planned, use of tobacco, alcohol, drug and medications and vaccinations received), presence of symptoms/signs consistent with ZIKV infection (fever, rash, non-purulent conjunctivitis, arthritis/arthralgia, lymphadenopathy, myalgia, headache) at any point throughout pregnancy, the woman’s environment (type of housing, number of rooms, number of people per household), preventative measures (use of repellent, protective clothing, window or bed nets, barrier contraception) and their knowledge of ZIKV and its forms of transmission as well as what their sources of information were |
Pregnant women follow-up 14–21 days after enrolment | Sample collection (blood, saliva, urine) for ZIKV RT-PCR and IgG/IgM Symptoms questionnaire - presence of symptoms/signs consistent with ZIKV infection (timing, duration, intensity, action taken) |
Pregnant women subsequent 2–3 monthly follow-ups | Sample collection (blood, saliva, urine) for ZIKV RT-PCR and IgG/IgM Symptoms questionnaire - presence of symptoms/signs consistent with ZIKV infection (timing, duration, intensity, action taken) Antenatal ultrasound at São Paulo foetal medicine centre |
Pregnant women weekly phone follow-up | Symptoms questionnaire - presence of symptoms/signs consistent with ZIKV infection (timing, duration, intensity, action taken) |
Birth (mother and neonate) | Sample collection (blood, saliva, urine) for ZIKV RT-PCR and IgG/IgM. Colostrum (mother) and cerebrospinal fluid (neonate exposed to ZIKV and/or with microcephaly) for ZIKV PCR. Anthropometry – weight, length, head circumference (neonate) Placenta and umbilical collection - pathology |
Neonatal, infant and child follow-ups | Sample collection (blood, saliva, urine) for ZIKV RT-PCR and IgG/IgM in months 1, 3, 6 and 15 for neonates. (Women found to be ZIKV RT-PCR positive during pregnancy also had blood, saliva and urine collected during paediatric follow-up appointments). Paediatric follow-up questionnaire – problems, significant events, feeding, vaccinations, developmental milestones reached, review of lab test results (including heel-prick test) Anthropometry – weight, length, head circumference Paediatric physical examination – general, cardiovascular, respiratory, gastrointestinal, neurological, developmental Physiotherapy assessment Speech and language assessment |
ZIKV exposed infants and/or with microcephaly/other neurological abnormalities | Opthalmology assessment (with Teller-CAT Cambridge Colour Test, funduscopy and extrinsic ocular motility tests) Specialist neurodevelopmental assessment (using Bayley-III developmental scales) Specialist audiology assessment Gastrointestinal assessment Imaging – Cranial ultrasound and CT brain at birth and 12 months |
PCR, polymerase chain reaction; RT-PCR, reverse transcription polymerase chain reaction; ZIKV, Zika virus.