TABLE 6.
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 | 2168,169 | 44/174 (25.3%) | 54/174 (31.0%) | 0.72 (0.25–2.06) | 0.54 | 87 | NA | Low |
Spontaneous preterm birth <37 weeks | 2168,169 | 102/174 (58.6%) | 98/174 (56.3%) | 1.01 (0.85–1.20) | 0.88 | 0 | NA | High |
Spontaneous preterm birth <32 weeks | 1168 | 24/106 (22.6%) | 22/108 (20.4%) | 1.11 (0.67–1.86) | 0.69 | NA | NA | Low |
Spontaneous preterm birth <28 weeks | 2168,169 | 18/174 (10.3%) | 17/174 (9.8%) | 0.93 (0.23–3.71) | 0.91 | 75 | NA | Low |
Preterm birth <37 weeks | 1168 | 72/106 (67.9%) | 71/108 (65.7%) | 1.03 (0.86–1.25) | 0.73 | NA | NA | Moderate |
Preterm birth <34 weeks | 2168,169 | 49/174 (28.2%) | 56/174 (32.2%) | 0.77 (0.26–2.26) | 0.63 | 89 | NA | Low |
Preterm birth <32 weeks | 1168 | 27/106 (25.5%) | 23/108 (21.3%) | 1.20 (0.73–1.95) | 0.47 | NA | NA | Low |
Preterm birth <28 weeks | 1168 | 14/106 (13.2%) | 9/108 (8.3%) | 1.58 (0.72–3.50) | 0.26 | NA | NA | Low |
Chorioamnionitis | 1169 | 2/68 (2.9%) | 2/66 (3.0%) | 0.97 (0.14–6.69) | 0.98 | NA | NA | Low |
PPROM | 2168,169 | 23/174 (13.2%) | 27/174 (15.5%) | 0.54 (0.09–3.33) | 0.51 | 67 | NA | Low |
Vaginal discharge | 2168,169 | 102/160 (63.8%) | 55/163 (33.7%) | 1.86 (1.51–2.28) | <0.0001 | 0 | NA | High |
Vaginal infection | 1168 | 22/89 (24.7%) | 11/87 (12.6%) | 1.96 (1.01–3.79) | 0.047 | NA | NA | Moderate |
Vaginal bleeding | 1169 | 3/68 (4.4%) | 3/66 (4.5%) | 0.97 (0.20–4.64) | 0.97 | NA | NA | Low |
Pelvic discomfort | 1168 | 6/92 (6.5%) | 6/97 (6.2%) | 1.05 (0.35–3.15) | 0.92 | NA | NA | Low |
Use of tocolytic agents | 1169 | 22/68 (32.4%) | 29/66 (43.9%) | 0.74 (0.47–1.14) | 0.17 | NA | NA | Low |
Cesarean delivery | 2168,169 | 96/174 (55.2%) | 92/174 (52.9%) | 1.05 (0.87–1.27) | 0.59 | 0 | NA | Moderate |
Maternal death | 2168,169 | 0/174 (0.0%) | 0/174 (0.0%) | Not estimable | NA | NA | NA | Low |
Perinatal outcomes | ||||||||
Fetal death | 2168,169 | 10/348 (2.9%) | 10/348 (2.9%) | 0.88 (0.20–3.88) | 0.86 | 28 | 1.04 (0.35–3.11) | Low |
Neonatal death | 2168,169 | 10/348 (2.9%) | 4/348 (1.1%) | 2.55 (0.81–8.00) | 0.11 | NA | 3.05 (0.63–14.82) | Low |
Perinatal death | 2168,169 | 20/348 (5.8%) | 14/348 (4.0%) | 0.96 (0.14–6.34) | 0.96 | 48 | 1.54 (0.65–3.66) | Low |
Birthweight <1500 g | 2168,169 | 58/348 (16.7%) | 53/348 (15.2%) | 1.05 (0.63–1.74) | 0.86 | 45 | 1.11 (0.71–1.73) | Low |
Birthweight <2500 g | 2168,169 | 196/348 (56.3%) | 212/348 (60.9%) | 0.89 (0.64–1.22) | 0.46 | 76 | 0.89 (0.65–1.24) | Low |
Respiratory distress syndrome | 2168,169 | 39/328 (11.9%) | 35/334 (10.5%) | 1.16 (0.76–1.78) | 0.49 | 0 | 1.20 (0.69–2.07) | Moderate |
Necrotizing enterocolitis | 2168,169 | 5/328 (1.5%) | 4/334 (1.2%) | 0.98 (0.08–12.26) | 0.99 | 57 | 0.89 (0.09–8.84) | Very low |
Intraventricular hemorrhage | 2168,169 | 8/328 (2.4%) | 10/334 (3.0%) | 0.55 (0.04–6.96) | 0.64 | 66 | 0.67 (0.06–7.11) | Very low |
Neonatal sepsis | 2168,169 | 26/328 (7.9%) | 25/334 (7.5%) | 1.09 (0.65–1.85) | 0.74 | 0 | 1.11 (0.60–2.05) | Low |
Retinopathy of prematurity | 2168,169 | 9/328 (2.7%) | 2/334 (0.6%) | 4.78 (1.05–21.85) | 0.04 | NA | 5.34 (0.63–45.07) | Low |
Any composite adverse neonatal outcome | 2168,169 | 42/328 (12.8%) | 42/334 (12.6%) | 0.98 (0.54–1.76) | 0.94 | 39 | 1.05 (0.62–1.75) | Low |
Admission to NICU | 1168 | 86/212 (40.6%) | 72/216 (33.3%) | 1.22 (0.95–1.56) | 0.12 | NA | 1.23 (0.88–1.72) | Moderate |
Mechanical ventilation | 1168 | 40/192 (20.8%) | 28/204 (13.7%) | 1.52 (0.98–2.36) | 0.06 | NA | 1.46 (0.81–2.64) | 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.