TABLE 5.
Outcome | No of trials | Pessary | No pessary | Relative risk (95% CI) | P value | I2, % | Adjusted relative riska (95% CI) | Quality of evidence |
---|---|---|---|---|---|---|---|---|
Pregnancy/maternal outcomes | ||||||||
Spontaneous preterm birth <34 weeks | 3168−170 | 87/577 (15.1%) | 99/551 (18.0%) | 0.75 (0.41–1.36) | 0.34 | 69 | NA | Low |
Spontaneous preterm birth <37 weeks | 3168−170 | 196/577 (34.0%) | 201/551 (36.5%) | 0.79 (0.48–1.30) | 0.35 | 74 | NA | Low |
Spontaneous preterm birth <32 weeks | 1168 | 38/486 (7.8%) | 42/462 (9.1%) | 0.86 (0.57–1.31) | 0.48 | NA | NA | Moderate |
Spontaneous preterm birth <28 weeks | 3168−170 | 25/577 (4.3%) | 26/551 (4.7%) | 0.90 (0.49–1.68) | 0.75 | 18 | NA | Moderate |
Preterm birth <37 weeks | 3167,168,170 | 338/587 (57.6%) | 320/540 (59.3%) | 0.95 (0.85–1.06) | 0.37 | 18 | NA | High |
Preterm birth <34 weeks | 3168−170 | 104/577 (18.0%) | 112/551 (20.3%) | 0.80 (0.45–1.42) | 0.44 | 72 | NA | Low |
Preterm birth <32 weeks | 2167,168 | 57/564 (10.1%) | 63/517 (12.2%) | 0.72 (0.38–1.34) | 0.30 | 62 | NA | Low |
Preterm birth <28 weeks | 3167,168,170 | 24/587 (4.1%) | 27/540 (5.0%) | 0.71 (0.28–1.82) | 0.47 | 59 | NA | Low |
Chorioamnionitis | 2169,170 | 4/91 (4.4%) | 3/89 (3.4%) | 1.30 (0.29–5.76) | 0.73 | 0 | NA | Low |
PPROM | 3168−170 | 89/577 (15.4%) | 83/551 (15.1%) | 0.76 (0.34–1.72) | 0.52 | 49 | NA | Low |
Vaginal discharge | 3168−170 | 285/557 (51.2%) | 140/531 (26.4%) | 1.93 (1.66–2.23) | <0.0001 | 0 | NA | High |
Vaginal infection | 1168 | 91/458 (19.9%) | 70/400 (17.5%) | 1.14 (0.86–1.50) | 0.38 | NA | NA | Moderate |
Pelvic discomfort | 1168 | 29/466 (6.2%) | 26/442 (5.9%) | 1.06 (0.63–1.77) | 0.83 | NA | NA | Moderate |
Use of tocolytic agents | 2167,169 | 38/146 (26.0%) | 47/121 (38.8%) | 0.69 (0.49–0.98) | 0.04 | 0 | NA | High |
Cesarean delivery | 3168−170 | 388/577 (67.2%) | 329/551 (59.7%) | 1.08 (0.92–1.28) | 0.34 | 24 | NA | Moderate |
Perinatal outcomes | ||||||||
Fetal death | 3167−169 | 15/1265 (1.2%) | 20/1167 (1.7%) | 0.71 (0.36–1.38) | 0.31 | 0 | 0.70 (0.30–1.64) | Low |
Neonatal death | 4167−170 | 20/1311 (1.5%) | 32/1213 (2.6%) | 0.56 (0.13–2.35) | 0.43 | 80 | 0.55 (0.14–2.12) | Low |
Perinatal death | 3167−169 | 31/1265 (2.5%) | 49/1167 (4.2%) | 0.42 (0.13–1.31) | 0.13 | 71 | 0.50 (0.20–1.25) | Low |
Birthweight <1500 g | 2168,169 | 100/1104 (9.1%) | 98/1053 (9.3%) | 0.97 (0.72–1.30) | 0.84 | 0 | 0.97 (0.68–1.38) | Moderate |
Birthweight <2500 g | 2168,169 | 596/1104 (54.0%) | 611/1053 (58.0%) | 0.87 (0.68–1.11) | 0.26 | 64 | 0.89 (0.70–1.12) | Moderate |
Respiratory distress syndrome | 4167−170 | 123/1286 (9.6%) | 102/1183 (8.6%) | 1.13 (0.88–1.45) | 0.34 | 0 | 1.14 (0.82–1.56) | Moderate |
Necrotizing enterocolitis | 4167−170 | 9/1286 (0.7%) | 9/1183 (0.8%) | 1.00 (0.40–2.48) | 0.99 | 0 | 1.00 (0.38–2.63) | Low |
Intraventricular hemorrhage | 4167−170 | 19/1286 (1.5%) | 21/1183 (1.8%) | 0.57 (0.12–2.65) | 0.48 | 54 | 0.60 (0.15–2.31) | Low |
Neonatal sepsis | 4167−170 | 74/1286 (5.8%) | 62/1183 (5.2%) | 1.05 (0.62–1.77) | 0.86 | 19 | 1.08 (0.57–2.06) | Moderate |
Retinopathy of prematurity | 3168−170 | 12/1129 (1.1%) | 3/1072 (0.3%) | 3.40 (1.04–11.09) | 0.04 | 0 | 3.25 (0.80–13.22) | Low |
Bronchopulmonary dysplasia | 2167,170 | 4/203 (2.0%) | 7/157 (4.5%) | 0.59 (0.16–2.20) | 0.43 | 10 | 0.77 (0.19–3.02) | Low |
Periventricular leukomalacia | 1167 | 0/157 (0.0%) | 1/111 (0.9%) | 0.24 (0.01–5.75) | 0.38 | NA | 0.24 (0.01–5.71) | Low |
Any composite adverse neonatal/perinatal outcome | 4167−170 | 145/1286 (11.3%) | 139/1183 (11.7%) | 0.86 (0.50–1.49) | 0.58 | 77 | 0.90 (0.54–1.53) | Low |
Admission to NICU | |168 | 301/972 (31.0%) | 276/924 (29.9%) | 1.05 (0.87–1.28) | 0.60 | NA | 1.04 (0.86–1.24) | High |
Mechanical ventilation | 1168 | 102/972 (10.5%) | 83/924 (9.0%) | 1.17 (0.89–1.54) | 0.27 | NA | 1.18 (0.81–1.70) | Moderate |
Data are n/N.
CI, confidence interval; NA, not applicable; NICU, neonatal intensive care unit; PPROM, preterm premature rupture of membranes.
Taking into account the non-independence of perinatal outcomes between twins.