Table V.
Secondary analyses: selected birth defects with first trimester IIV exposure as compared to IIV unexposed in pregnancy
| Birth defect types | Unexposed to IIV during pregnancy (n = 282 091) |
IIV Exposed in first trimester (n = 52 552)* |
Adjusted Prevalence difference 95% CI, P value |
Adjusted Prevalence ratio, P value |
|---|---|---|---|---|
| Selected major structural birth defects† | 4284 (1.5 per 100 live births) | 861 (1.6 per 100 live births) | 0.04% (−0.09 to 0.16), .55 | 1.02 (0.94-1.10), .55 |
| Selected major structural birth defects by organ system | n (rate per 10 000 live births) | n (rate per 10 000 live births) | Per 10 000 live births | |
| Any cardiac | 1566 (56) | 306 (58) | −1 (−9 to 6), .70 | 0.98 (0.87-1.10), .79 |
| Severe cardiac | 353 (13) | 68 (13) | −1 (−5 to 2), .52 | 0.93 (0.71,1.20), .57 |
| Central nervous system | 438 (16) | 86 (16) | 1 (−3 to 5), .57 | 1.05 (0.83, 1.30), .68 |
| Neural tube defects | 67 (2) | 9 (2) | –1 (−2 to 0), .16 | 0.67 (0.33, 1.40), .27 |
| Microcephaly | 309 (11) | 62 (12) | 1 (−2 to 5), .40 | 1.11 (0.84, 1.50), .44 |
| Ophthalmologic or otologic | 112 (4) | 23 (4) | 0 (−2 to 2), .71 | 1.09 (0.68-1.80), .72 |
| Gastrointestinal | 659 (23) | 113 (22) | 0 (−5 to 4), .84 | 0.97 (0.79-1.20), .77 |
| Genitourinary or renal | 1057 (37) | 247 (47) | 4 (−4 to 10), .26 | 1.09 (0.94-1.30), .26 |
| Muscular or limb defects | 230 (8) | 44 (8) | −0 (−3 to 2), .73 | 0.93 (0.67, 1.30), .67 |
| Respiratory or orofacial | 385 (14) | 73 (14) | 0 (−4 to 4), .97 | 1.0 (0.77, 1.30), .98 |
| Cleft lip and/or cleft palate | 372 (13) | 68 (13) | 0 (−4 to 3), .86 | 0.97 (0.74, 1.30), .84 |
In these secondary analyses, n = 301 women with a first trimester IIV exposure excluded as they also had a second or third trimester IIV exposure.
Selected major structural birth defects include the following diagnoses, with outcome-specific algorithms applied: neural tube defects (spina bifida [741.0x and 741.9x], encephalocele, cranial meningocele, or encephalomyelocele [742.0]), other central nervous system (microcephaly [742.1], holoprosencephaly [742.2]), Ophthalmologic (anophthalmia or microphthalmia [743.00 and 743.10-743.12], cataracts and other lens defects [743.2x and 743.30-743.36]), otologic (anotia or microtia [744.01 and 744.23]), severe cardiac (single ventricle, tricuspid atresia, Ebstein anomaly, hypoplastic left heart, hypoplastic right heart, common truncus, transposition, atrioventricular septal defects, tetralogy of Fallot, aortic valve atresia/stenosis, coarctation, total anomalous pulmonary venous return, and anomalous coronary artery [745.0, 745.1x, 745.2-745.3, 745.6x, 745.7, 746.00, 746.01, 746.1-746.3, 746.7, 746.85, 747.1x, 747.22, and 747.41]), other cardiac (septal defects, heterotaxy, partial anomalous pulmonary venous return [745.4, 745.8, 745.9, and 759.3, and 747.42]), cleft lip or cleft palate (749.0, 749.00-749.04, 749.1, 749.10-749.14, 749.2, and 749.20-749.25), respiratory (choanal atresia [748.0]), gastrointestinal (esophageal atresia with or without tracheoesophageal fistula [750.3], pyloric stenosis [750.5], intestinal atresia or stenosis [751.1 and 751.2], biliary atresia [751.61]), genitourinary or renal (second- or third-degree hypospadias [752.61], renal agenesis or hypoplasia [753.0], renal dysplasia [753.15], congenital hydronephrosis [753.2x], bladder exstrophy [753.5], posterior urethral valve and/or prune belly [753.60 and 756.71]), muscular or limb defects (limb deficiency [755.2-755.9], sacral agenesis [756.13], diaphragmatic hernia [756.6], gastroschisis or omphalocele [756.72, 756.73, and 756.79]).