Table 1:
Baseline characteristics of patients receiving adjunctive azithromycin or placebo at unscheduled cesarean delivery in the Cesarean Section Optimal Antibiotic Prophylaxis trial
| Characteristic | After skin incision (Median 3 mins, range 0-229mins) N=269 |
0-30mins pre-incision N=1378 |
>30-60mins pre-incision N=270 |
>60mins pre-incision (Median 85 mins, range 61-218 mins) N=96 |
||||
|---|---|---|---|---|---|---|---|---|
| Azithromycin n=135 |
Placebo n=134 |
Azithromycin n=693 |
Placebo n-685 |
Azithromycin n=140 |
Placebo n=130 |
Azithromycin n=51 |
Placebo n=45 |
|
| Maternal Age (years) | 28.9 ± 6.5 | 27.9 ± 6.8 | 28.1 ± 6.1 | 28.5 ± 6.5 | 27.8 ± 5.8 | 28.2 ± 6.3 | 29.2 ± 6.4 | 28.9 ± 6.2 |
| Race and ethnicity | ||||||||
| Hispanic | 19 (14.1) | 11 (8.2) | 128 (18.5) | 138 (20.1) | 39 (27.9) | 41 (31.5) | 17 (33.3) | 18 (40.0) |
| Non-Hispanic Black | 47 (34.8) | 53 (39.6) | 244 (35.2) | 237 (34.6) | 48 (34.3) | 41 (31.5) | 12 (23.5) | 10 (22.2) |
| Non-Hispanic White | 48 (35.6) | 47 (35.1) | 246 (35.5) | 242 (35.3) | 43 (30.7) | 41 (31.5) | 19 (37.3) | 12 (26.7) |
| None of the above | 21 (15.6) | 23 (17.2) | 75 (10.8) | 68 (9.9) | 10 (7.7) | 7 (5.4) | 3 (5.9) | 5 (11.1) |
| Medicaid | 82 (61.2) | 84 (63.2) | 424 (61.2) | 412 (60.1) | 84 (60.0) | 76 (59.8) | 32 (64.0) | 28 (63.6) |
| Nulliparous | 74 (54.8) | 83 (61.9) | 420 (60.6) | 405 (59.1) | 88 (62.9) | 83 (63.8) | 21 (41.2) | 21 (46.7) |
| Comorbidities | 27 (20.0) | 19 (14.2) | 116 (16.7) | 127 (18.5) | 22 (15.7) | 22 (16.9) | 8 (15.7) | 7 (15.6) |
| Substance use | 13 (9.6) | 16 (11.9) | 90 (13.0) | 109 (15.9) | 28 (20.0) | 29 (22.3) | 12 (23.5) | 10 (22.2) |
| Preterm birth (<37 weeks) | 23 (17.0) | 18 (13.4) | 69 (10.0) | 83 (12.1) | 19 (13.6) | 15 (11.5) | 6 (11.8) | 4 (8.9) |
| Group B streptococcus status | 38 (28.2) | 38 (28.4) | 170 (24.5) | 189 (27.6) | 29 (20.7) | 28 (21.5) | 12 (23.5) | 11 (24.4) |
| Spontaneous rupture of membranes | 56 (41.8)* | 37 (27.8)* | 247 (35.8) | 229 (33.5) | 49 (35.0) | 50 (38.5) | 21 (41.2) | 11 (24.4) |
| Body mass index (kg/m2) | 34.7 ± 7.4 | 34.2 ±7.8 | 35.2 ± 7.7 | 35.8 ± 7.9 | 36.3 ± 8.2 | 35.4 ± 7.7 | 36.1 ± 7.8 | 35.6 ± 7.2 |
| Duration of ruptured membranes (hours) | 16.8 ± 55.9 | 9.4 ± 7.3 | 12.7 ± 41.2 | 10.6 ±22.5 | 10.7 ± 8.1 | 12.0 ± 10.7 | 16.3 ± 56.4 | 9.9 ± 7.5 |
| Standard prophylactic antibiotic† | 134 (99.3) | 129 (96.3) | 680 (98.1) | 676 (98.7) | 137 (97.9) | 128 (98.5) | 49 (96.1) | 43 (95.6) |
*
Significantly different at p<0.05 in azithromycin (vs placebo) status
†
Standard prophylactic antibiotic was routinely cefazolin per protocol except in patients with penicillin or cephalosporin allergy who received the local alternative- clindamycin or clindamycin plus gentamicin.
‡
Comorbidities include pregestational diabetes, chronic hypertension, other cardiac disease or autoimmune disease
‖
Column total not 100% for health insurance type (Medicaid) and Spontaneous rupture of membranes) due to 1-3 participants missing data on these variables