Table 2.
Pregnancy and neonatal outcomes after exposure to isotretinoin during the periconception period
| Variable | GWs at first dose (weeks) | GWs at last dose (weeks) | Daily dose (mg) | Length of drug use (days) | Cumulative dose (mg) | Co-exposure drugs | Ultrasonography at second trimester | Ultrasonography at third trimester | Birth or neonatal outcomes | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gestational g/weeks at birth | Newborn outcomes | Screening test for inherited metabolic disorder | Screening test for hearing difficulty | |||||||||
| Evaluation of fetus in second or third trimester by ultrasonography and neonate by physical examination | ||||||||||||
| N1 | −4 | −3.1 | 10 | 8 | 80 | Yes | Unremarkable | Unremarkable | 40/3,960 | - | Negative | Negative |
| N2 | −4 | −2.1 | 10 | 14 | 140 | No | Unremarkable | - | 39.7/2,745 | Jaundice | Negative | Negative |
| N3 | −4 | −2 | 10 | 29 | 290 | Yes | Unremarkable | Unremarkable | 40.4/3385 | Bruising on right forearm | Negative | Negative |
| N4 | −4 | −1.5 | 10 | 30 | 300 | Yes | Unremarkable | Unremarkable | 38.1/3415 | TTN | Negative | Negative |
| N5 | −2.4 | −1.5 | 10 | 7 | 70 | Yes | Small for gestational age | Focally echogenic bowel | 40/2,860 | TTN, abdominal radiography: unremarkable | Negative | Negative |
| N6 | −4 | −0.6 | 10 | 23 | 230 | Yes | Unremarkable | Unremarkable | 41/3,210 | - | - | - |
| N7 | −1 | −0.3 | 10 | 5 | 50 | Yes | Unremarkable | Unremarkable | 41/3,100 | - | - | - |
| N8 | −4 | 0.2 | 15 | 30 | 450 | No | Unremarkable | Unremarkable | 38.5/3,075 | Dolicocephalic head, skull series: unremarkable | Negative | - |
| N9 | −1.2 | 0.2 | 20 | 7 | 140 | Yes | Unremarkable | Prominent fetal large bowel and rectum | 37.8/3,375 | Abdominal radiography: unremarkable | Negative | Negative |
| N10 | −4 | 0.3 | - | 17 | 170 | No | Bilateral CPC, upper normal range of both renal pelvis diameter of fetus | Unremarkable | 39.1/3,455 | Brain ultrasonography: unremarkable Physical examination: unremarkable | Negative | - |
| N11 | −3.6 | 1.2 | 10 | 3 | 30 | Yes | Unremarkable | Unremarkable | 40.1/3,505 | Albinism and brown hair | Negative | Negative |
| N12 | 1.1 | 1.3 | 20 | 3 | 60 | Yes | Unremarkable | Unremarkable | 39.5/3,000 | - | - | - |
| N13 | −4 | 1.4 | 10 | 5 | 50 | Yes | A small septate right CPC of fetal brain | Unremarkable | 38/3,210 | TTN, dimple at left lower leg | - | Negative |
| N14 | 1.3 | 1.5 | 10 | 3 | 30 | No | Unremarkable | Unremarkable | 41.1/3,250 | - | Negative | Negative |
| N15 | −4 | 2.2 | 10 | 44 | 440 | Yes | Relatively small-sized fetal stomach with echogenic debris | Unremarkable | 39.7/3,470 | TTN, nasolacrimal duct obstruction | - | Negative |
| N16 | −4 | 3 | 10 | 10 | 100 | Yes | Unremarkable | Unremarkable | 40.8/3,345 | - | Negative | Negative |
| N17 | 3 | 3.5 | 10 | 6 | 60 | Yes | Unremarkable | Unremarkable | 39.4/3,365 | - | Negative | Negative |
| N18 | −4 | 4.3 | 10 | 14 | 140 | Yes | Unremarkable | Unremarkable | 39.7/3,250 | Skin tag on the right ear | Negative | Negative |
| N19 | 3 | 4.3 | 10 | 6 | 60 | Yes | Right preauricular area skin tag, curling toe, left 4th | Bilateral preauricular skin tags, curling toe of left foot fourth toe than polydactyly | - | Bilateral preauricular skin tags, postaxial polysyndactyly with curling toe of left foot | - | - |
| N20 | 4.1 | 4.5 | 20 | 5 | 100 | Yes | Unremarkable | Unremarkable | 41/3,735 | - | Negative | Negative |
| N21 | 4.2 | 4.6 | 10 | 3 | 30 | No | Unremarkable | Unremarkable | 39.4/3,000 | - | Negative | Negative |
| N22 | 0.1 | 5.5 | 15 | 40 | 400 | No | Unremarkable | Unremarkable | 40.1/2,820 | - | Negative | Negative |
| N23 | −0.2 | 5.6 | 20 | 30 | 600 | Yes | Unremarkable | Unremarkable | 40/3,700 | - | Negative | Negative |
| Evaluation of fetus in second or third trimester by ultrasonography | ||||||||||||
| F1 | −4 | −3.4 | 10 | 6 | 60 | Yes | VSD | - | - | - | - | - |
| F2 | −3.3 | −3.1 | 14.7 | 15 | 220 | Yes | Unremarkable | - | - | - | - | - |
| F3 | −4 | −1.6 | 10 | 18 | 180 | Yes | Unremarkable | Unremarkable | - | - | - | - |
| F4 | −2.5 | −0.6 | 10 | 14 | 140 | No | Unilateral borderline ventriculomegaly, left (10 mm) | - | - | - | - | - |
| F5 | −4 | −0.6 | 20 | 12 | 240 | Yes | Unremarkable | - | - | - | - | - |
| F6 | −4 | 0.5 | 15 | 33 | 495 | Yes | Unremarkable | - | - | - | - | - |
| F7 | −4 | 1.3 | 10 | 23 | 230 | No | Unremarkable | Unremarkable | - | - | - | - |
| F8 | 1.1 | 1.3 | 17.7 | 13 | 230 | Yes | Unremarkable | Unremarkable | - | - | - | - |
| F9 | 0.1 | 2.1 | 20 | 7 | 140 | Yes | Transient premature atrial contraction of heart | - | - | - | - | - |
| F10 | −3.4 | 2.6 | 10 | 16 | 160 | Yes | Unremarkable | - | - | - | - | - |
| F11 | 3.2 | 3.4 | 10 | 3 | 30 | Yes | Unremarkable | - | - | - | - | - |
| F12 | −1.2 | 3.4 | 10 | 34 | 340 | Yes | Unremarkable | - | - | - | - | - |
| F13 | −4 | 4 | 5 | 10 | 50 | No | small stomach size | - | - | - | - | - |
| F14 | 4.2 | 4.2 | 10 | 2 | 20 | Yes | Unremarkable | - | - | - | - | - |
| F15 | −4 | 4.2 | 10 | 23.2 | 232 | Yes | Unremarkable | - | - | - | - | - |
| F16 | 4.5 | 4.6 | 10 | 2 | 20 | Yes | Unremarkable | - | - | - | - | - |
| F17 | 0.6 | 5.1 | 10 | 10 | 100 | Yes | Unremarkable | - | - | - | - | - |
| F18 | 6 | 7.6 | 10 | 4 | 40 | Yes | Unremarkable | - | - | - | - | - |
| F19 | 12.1 | 13.8 | 10 | 12 | 120 | No | Unremarkable | - | - | - | - | - |
GWs, gestational weeks; N, neonate followed up after birth; F, fetus followed up until the second or third trimester of pregnancy; TTN, transient tachypnea of the newborn; CPC, choroid plexus cyst; VSD, ventricular septal defect.