Table 2.
Characteristics of prospective and retrospective pregnancy cases with known outcome*
| Prospective pregnancies (n = 137) | Retrospective pregnancies (n = 95) | Total (N = 232) | |
|---|---|---|---|
| Maternal age | |||
| Age known, n | 97 | 49 | 146 |
| <35 years | 56 (57.7) | 20 (40.8) | 76 (52.1) |
| ≥35 years | 41 (42.3) | 29 (59.2) | 70 (47.9) |
| BOTOX indication MedDRA preferred term | |||
| Indication known, n | 128 | 62 | 190 |
| Cosmetic | 70 (54.7) | 26 (41.9) | 96 (50.5) |
| Skin cosmetic procedure | 1 | 0 | 1 |
| Skin wrinkling | 69 | 26 | 95 |
| Gastrointestinal disorders | 1 (0.8) | 2 (3.2) | 3 (1.6) |
| Anal fissure | 1 | 0 | 1 |
| Esophageal achalasia | 0 | 2 | 2 |
| Hyperhidrosis | 12 (9.4) | 10 (16.1) | 22 (11.6) |
| Hyperhidrosis | 12 (9.4) | 10 (16.1) | 22 (11.6) |
| Movement disorders | 15 (11.7) | 17 (27.4) | 32 (16.8) |
| Blepharospasm | 1 | 0 | 1 |
| Dystonia | 4 | 0 | 4 |
| Hemiparesis | 1 | 0 | 1 |
| Muscle contracture | 0 | 1 | 1 |
| Spasmodic dysphonia | 1 | 2 | 3 |
| Strabismus | 0 | 1 | 1 |
| Torticollis | 8 | 13 | 21 |
| Pain disorders | 22 (17.2) | 5 (8.1) | 27 (14.2) |
| Headache | 2 | 0 | 2 |
| Migraine | 17 | 5 | 22 |
| Muscle spasms | 2 | 0 | 2 |
| Pelvic pain | 1 | 0 | 1 |
| Spasticity | 3 (2.3) | 1 (1.6) | 4 (2.1) |
| Muscle spasticity | 3 | 1 | 4 |
| Urological disorders | 5 (3.9) | 1 (1.6) | 6 (3.2) |
| Cystitis interstitial | 1 | 0 | 1 |
| Hypertonic bladder | 1 | 0 | 1 |
| Neurogenic bladder | 3 | 1 | 4 |
| Timing of exposure | |||
| Timing known, n | 124 | 77 | 201 |
| Prior to conception | |||
| >2–3 months | 2 (1.6) | 1 (1.3) | 3 (1.5) |
| >1–2 months | 7 (5.6) | 2 (2.6) | 9 (4.5) |
| 0–1 month | 12 (9.7) | 3 (3.9) | 15 (7.5) |
| First trimester | 98 (79.0) | 68 (88.3) | 166 (82.6) |
| Second trimester | 5 (4.0) | 1 (1.3) | 6 (3.0) |
| Third trimester | 0 (0) | 2 (2.6) | 2 (1.0) |
| BOTOX dose | |||
| Dose known, n | 95 | 42 | 137 |
| <50U | 40 (42.1) | 15 (35.7) | 55 (40.1) |
| 50U to <100U | 13 (13.7) | 7 (16.7) | 20 (14.6) |
| 100U to <150U | 17 (17.9) | 9 (21.4) | 26 (19.0) |
| 150U to <200U | 10 (10.5) | 2 (4.8) | 12 (8.8) |
| 200U to <250U | 6 (6.3) | 3 (7.1) | 9 (6.6) |
| 250U to <300U | 1 (1.1) | 0 (0) | 1 (0.7) |
| 300U to <350U | 6 (6.3) | 1 (2.4) | 7 (5.1) |
| 350U to <400U | 2 (2.1) | 0 (0) | 2 (1.5) |
| >400U | 0 (0) | 5 (11.9) | 5 (3.6) |
MedDRA = Medical Dictionary for Regulatory Activities.
*
Data are expressed as n or n (% among those with known information).