Table 4.
Results
| Outcome measure | Study | Treatment group | Control group | Difference between groups | ||
|---|---|---|---|---|---|---|
| Specification | N | Events (%) | N | Events (%) | OR [95 % CI]; p-value | |
| Pyelonephritis | ||||||
| Kazemier [21] | 40 | 0 (0) | 45 | 1 (2.2) | 0.37a [0.01; 9.25]a; 0.515b | |
| Williams [22] | 85c | 5 (6) | 78c | 18 (23) | 0.21a [0.07–0.59]a; 0.002b | |
| Lower UTI | ||||||
| Treated with AB during pregnancy | Kazemier [21] | 40 | 4 (10) | 45 | 8 (18) | POR 0.53a [0.16; 1.79]a; 0.357b |
| Recurrent UTI treated with AB during pregnancy | Kazemier [21] | 40 | 0 (0) | 45 | 1 (2.2) | 0.37a [0.01; 9.25]a; 0.515b |
| Treated with AB postpartum (within 6 weeks) | Kazemier [21] | 40 | 3 (7.5) | 45 | 1 (2.2) | POR 3.20a [0.43; 23.63]a; 0.296b |
| Pre- and post-partald | Mulla [20] | 50 | 3 (6) | 50 | 20 (40) | 0.10a [0.03–0.35]a; < 0.001b |
| Preterm birth | ||||||
| < 37 weekse | Kazemier [21] | 40 | 2f (5) | 45 | 2 (4.4) | POR 1.13a [0.15; 8.35]a; 0.975b |
| < 32 weeks | Kazemier [21] | 40 | 1 (2.5) | 45 | 0 (0) | 3.46a [0.14; 87.26]a; 0.357b |
| Infant morbidity | ||||||
| Kernicterus | Elder [19] | 54 | 0g | 52 | 0g | n. a. |
| Composite severe morbidityh | Kazemier [21] | 40 | 0 (0) | 45 | 2 (4.4) | 0.21a [0.01; 4.61]a; 0.220b |
| Admission to NICU | Kazemier [21] | 40 | 2 (5) | 45 | 0 (0) | 5.91a [0.28; 126.85]a; 0.169b |
| Neonatal sepsis confirmed with culture | Kazemier [21] | 40 | 0 (0) | 45 | 2 (4.4) | 0.21a [0.01; 4.61]a; 0.220b |
| Congenital abnormalities | Kazemier [21] | 40 | 0 (0) | 45 | 1 (2.2) | 0.37a [0.01; 9.25]a; 0.515b |
| Infant mortality | ||||||
| Perinatal death | Kazemier [21] | 40 | 1 (2.5) | 45 | 0 (0) | 3.46a [0.14; 87.26]a; 0.357b |
| Adverse events | ||||||
| Vomiting | Elder [19] | 54 | 1 | 52 | 0 | n. a. |
| Rashes, pruritus | Elder [19] | 54 | 0f | 52 | 0f | n. a. |
| Photosensitivity | Elder [19] | 54 | 0f | 52 | 0f | n. a. |
| Discontinuations due to adverse events | Mulla [20] | 50 | 0 | 50 | 0 | n. a. |
| Pre-eclampsiae | Kazemier [21] | 40 | 2 (5) | 45 | 1 (2.2) | POR 2.24a [0.23; 22.22]a; 0.596b |
| HELLP syndrome | Kazemier [21] | 40 | 2 (5) | 45 | 0 (0) | 5.91a [0.28; 126.85]a; 0.169b |
| Kidney stones, cholestasis | Kazemier [21] | 40 | 0 (0) | 45 | 0 (0) | RD 0 [-9,4; 10,5] |
| Thrombo-embolic events | Kazemier [21] | 40 | 0 (0) | 45 | 0 (0) | RD 0 [-9,4; 10,5] |
| Endometritis (within 6 weeks of delivery) | Kazemier [21] | 40 | 0 (0) | 45 | 0 (0) | RD 0 [-9,4; 10,5] |
| Mastitis (within 6 weeks of delivery) | Kazemier [21] | 40 | 1 (2.5) | 45 | 1 (2.2) | POR 1.13a [0.07; 18.41]a; 0.997b |
AB antibiotics, CI confidence interval, CSZ convexity, symmetry, z score, HELLP haemolysis, elevated liver enzymes, low platelet count syndrome, n. a not available, NICU Neonatal Intensive Care Unit, OR odds ratio, POR Peto odds ratio, RD risk difference, UTI urinary tract infection
aIQWiG’s own calculation
bIQWiG’s own calculation, unconditioned exact test (CSZ method as described in [25])
cNumber of participants analysed; number of randomised participants not stated
dThe outcome was named either cystopyelitis or symptomatic UTI; neither term was defined. It was therefore unclear which stage of UTI the reported outcome represented. Following a conservative approach, we classified the outcome as lower UTI. However, it is possible that cases of upper UTI were also included
eConsidered a non-patient-relevant outcome
fOne event is also included in preterm births < 32 weeks
gIt is unclear whether the reported event rate relates to both study groups; alternatively, the event rate may relate solely to the treatment group or to any pregnant participant with or without bacteriuria
hRespiratory distress syndrome, necrotizing enterocolitis, intraventricular haemorrhage, bronchopulmonary disease, sepsis