Table 2. Preterm Delivery and Fetal Death and Maternal Secondary Outcomes.
| Outcomes | Pessary (n = 279) | Usual care (n = 263) | Absolute median difference (95% CI) | Unadjusted relative risk (95% CI) |
|---|---|---|---|---|
| Primary outcome | ||||
| Preterm delivery or fetal death <37 wk, No. (%) | 127 (45.5) | 120 (45.6) | 1.00 (0.83-1.20) | |
| Preterm delivery <37 wk, No. (%) | 109 (39.1) | 111 (42.2) | ||
| Fetal death <37 wk, No. (%)a | 18 (6.5) | 9 (3.4) | ||
| Secondary outcomes | ||||
| Time from enrollment to delivery or fetal death, median (IQR), d | 105 (42-20) | 103 (56-118) | 2 (−4 to 8) | |
| Gestational age at delivery, median (IQR), wk | 37.3 (27.4-39.1) | 37.4 (29.6-39.1) | 0.1 (−0.8 to1.1) | |
| Preterm delivery or fetal death, No. (%) | ||||
| <28 wk | 72 (25.8) | 54 (20.5) | 1.26 (0.92-1.71) | |
| <32 wk | 93 (33.3) | 73 (27.8) | 1.20 (0.93-1.55) | |
| <35 wk | 111 (39.8) | 90 (34.2) | 1.16 (0.93-1.45) | |
| Preterm premature rupture of membranes, No./total (%) | 64/277 (23.1) | 46/207 (17.8) | 1.30 (0.92-1.82) | |
| Spontaneous preterm delivery, No. (%) | 109 (39.1) | 106 (40.3) | 0.97 (0.79-1.19) | |
| Indicated preterm delivery, No. (%) | 18 (6.5) | 14 (5.3) | 1.21 (0.61-2.39) | |
| Cesarean delivery, No. (%) | 86 (30.8) | 80 (30.4) | 1.01 (0.79-1.31) | |
| Chorioamnionitis, No. (%) | 18 (6.5) | 16 (6.1) | 1.06 (0.55-2.04) | |
| Antepartum length of stay, median (IQR), d | 1 (0-1) | 1 (0-1) | 0 (0 to 0) | |
| Vaginal infection, No./total (%)b | 57/226 (25.2) | 41/220 (18.6) | 1.36 (0.95-1.94) | |
| Antibiotic or antifungal treatment, No./total (%)b | 55/226 (24.3) | 37/220 (16.8) | 1.45 (0.99-2.06) | |
| Treatment for preterm labor, No./total (%)c | 150/258 (58.1) | 143/250 (57.2) | 1.02 (0.88-1.18) | |
| Cerclage placement, No. (%) | 13 (4.7) | 24 (9.1) | 0.51(0.27-0.98) | |
| Pessary removal reasons, No. (%) | n = 276 | |||
| Medically indicated | 230 (83.3) | |||
| Final study visit | 104 (37.7) | |||
| Preterm premature rupture of membranes | 53 (19.2) | |||
| Preterm labor | 42 (15.2) | |||
| Delivery | 9 (3.3) | |||
| Vaginal bleeding | 7 (2.5) | |||
| Uterine contractions | 7 (2.5) | |||
| Cervical dilation ≥3 cm | 7 (2.5) | |||
| Confirmed clinical chorioamnionitis | 1 (0.4) | |||
| Not medically indicated | 46 (16.7) | |||
| Patient request (any reason) | 23 (8.3) | |||
| Cerclage | 7 (2.5) | |||
| Clinician request | 5 (1.8) | |||
| Self-removed | 4 (1.5) | |||
| Spontaneous dislodgement | 3 (1.1) | |||
| Recruitment closure | 2 (0.7) | |||
| Cervical erosion | 1 (0.4) | |||
| Incontinence | 1 (0.4) | |||
a
Includes only delivery prior to 20 weeks or fetal deaths that occurred prior to delivery, and not infant deaths following delivery at or after 20 weeks.
b
Participants with at least 1 study visit. Vaginal infection includes chlamydia, gonorrhea, syphilis, trichomonas, bacterial vaginosis, genital herpes, HIV, hepatitis B, hepatitis C, hepatitis D, pyelonephritis, cystitis, or candidiasis diagnosed during the current pregnancy. Antibiotics include those administered after randomization and before delivery via intravenous, oral, and vaginal routes.
c
Treatment for preterm labor includes cerclage, bed rest, tocolysis, antenatal corticosteroids for fetal lung maturity, and magnesium sulfate for neuroprotection.