Prospective cohort studies of ZIKV infection during pregnancy

	Brasil et al, 2016^[1] Nielsen-Saines et al, 2019^[2]	Hoen et al, 2018^[3]	Pomar et al, 2018^[4]	Mulkey et al, 2019^[5] Mulkey et al, 2020^[6]	Ospina et al, 2020^[7]	Coutinho et al, 2020^[8]
Site and recruitment period	Rio de Janeiro, Brazil September 2015 to May 2016	French Guiana, Guadeloupe, and Martinique March 2016 to November 2016	French Guiana January 2016 to July 2016	Barranquilla, Colombia, and Washington, DC June 2016 to June 2017	Colombian national surveillance system June 2015 to July 2016	Ribeirão Preto, Brazil 2015 to 2016
Study design	Longitudinal	Longitudinal	Longitudinal	Longitudinal	Surveillance data	Longitudinal
Inclusion criteria for pregnant women	Symptomatic ZIKV infection with rash confirmed by RT-PCR of blood or urine (rash with onset ≤5 days)	Symptomatic ZIKV infection with at least one of the following confirmed by RT-PCR of blood or urine or both: rash, fever, conjunctivitis, arthralgia, or myalgia	Symptomatic or asymptomatic ZIKV infection confirmed by RT-PCR in blood or urine or ZIKV IgM	Symptomatic ZIKV infection with positive RT-PCR, IgM, IgG, or PRNT for ZIKV	Symptomatic ZIKV infection with positive RT-PCR in serum	Symptomatic ZIKV infection with positive RT-PCR of blood, urine, amniotic fluid, or placenta
Number of women with confirmed ZIKV infection in pregnancy	244	561	498	82	5926*	511
Number of miscarriages/fetal losses	10 (4.1%)	28 (5.0%)	32 (6.4%)	2 (2.4%)	172 (3.0%)	24 (4.7%)
Loss to follow-up before or immediately after birth or excluded participants	17 (7.0%)	15 (2.7%)	192 (38.6%)	0	253 (4.3%)	209 (42.7%)
Number of neonatal deaths	1 (0.5%)	Not reported	Not reported	1 (1.2%)	48 (0.9%)	2 (0.4%)
Number of infants with follow-up	216 (88.5%)	527 (93.9%)	279 (56.0%)	80 (97.5%)	0	280 (57.3%)
Median infant follow-up time	18 months (range 7 to 32 months)	Birth	3 days of life (range 0 to 7 days)	18 months (range 4 to 18 months)	Birth	Birth (range 0 to 3 months)
Outcome measure	Clinical abnormalities at birth and on follow-up Eye findings Hearing findings Neurodevelopment	Clinical findings on the day of birth	Clinical findings in the first week of life	Neuroimaging findings Neurodevelopment	Adverse pregnancy or neonatal outcome reported to surveillance system	Pregnancy losses Abnormalities at birth to 3 months of age
Microcephaly	8 (3.7%)	32 (5.8%)	31 (11.4%) of 273 infants	3 (3.7%)	93 (1.6%)^¶	16 (3.1%)
Small for gestational age	10 (4.6%)	53 (10%)	26 (10.2%) of 255 infants	Not reported	333 (6.2%)	45 (9.2%)
Preterm infants	28 (13%)	Not reported	Not reported	5 (6.3%)	409 (7.5%)	45 (9.2%)
Eye abnormalities on funduscopic examination	128 examined (59.3%) and 9 (7%) had abnormalities	39 with neurologic findings (7%)	Not reported	Not reported	93 (1.6%)^¶	174 examined (35.6%) and 8 (4.6%) had abnormalities
Hearing abnormalities	101 assessed (46.8%) and 13 (12%) had abnormalities	Not reported	Not reported	Not reported	Not reported	261 assessed (53.4%) and 1 (0.4%) had an abnormality
Below average neurodevelopment	Of 216 children evaluated, 62 (28.7%) had below average neurodevelopment	N/A	N/A	In 70 children evaluated, decline in neurodevelopment scores noted over time, 33% with abnormal findings	N/A	N/A
Neurodevelopment tool	Bayley-III Hammersmith Infant Neurological Examination	N/A	N/A	Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA) Alberta Infant Motor Scale (AIMS)	N/A	N/A

ZIKV: Zika virus; RT-PCR: reverse transcription polymerase chain reaction; IgM: immunoglobulin M; IgG: immunoglobulin G; PRNT: plaque reduction neutralization test; N/A: not available.
* 45% of 18,117 pregnant women with symptoms of ZIKV infection tested; 33% of 18,117 positive by RT-PCR.
¶ 1.6% for brain and eye defects combined. Individual microcephaly frequencies or individual eye abnormalities not reported. Eye abnormalities noted on physical inspection (not necessarily funduscopic evaluation).

References:

Brasil P, Pereira JP Jr, Moreira ME, et al. Zika Virus Infection in Pregnant Women in Rio de Janeiro. N Engl J Med 2016; 375:2321.
Nielsen-Saines K, Brasil P, Kerin T, et al. Delayed childhood neurodevelopment and neurosensory alterations in the second year of life in a prospective cohort of ZIKV-exposed children. Nat Med 2019; 25:1213.
Hoen B, Schaub B, Funk AL, et al. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med 2018; 378:985.
Pomar L, Vouga M, Lambert V, et al. Maternal-fetal transmission and adverse perinatal outcomes in pregnant women infected with Zika virus: prospective cohort study in French Guiana. BMJ 2018; 363:k4431.
Mulkey SB, Bulas DI, Vezina G, et al. Sequential Neuroimaging of the Fetus and Newborn With In Utero Zika Virus Exposure. JAMA Pediatr 2019; 173:52.
Mulkey SB, Arroyave-Wessel M, Peyton C, et al. Neurodevelopmental Abnormalities in Children With In Utero Zika Virus Exposure Without Congenital Zika Syndrome. JAMA Pediatr 2020; 174:269.
Ospina ML, Tong VT, Gonzalez M, et al. Zika Virus Disease and Pregnancy Outcomes in Colombia. N Engl J Med 2020; 383:537.
Coutinho CM, Negrini S, Araujo D, et al. Early maternal Zika infection predicts severe neonatal neurological damage: results from the prospective Natural History of Zika Virus Infection in Gestation cohort study. BJOG 2020.

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Prospective cohort studies of ZIKV infection during pregnancy