Perinatology Research Branch, Division of Obstetrics and Maternal-Fetal Medicine, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, US Department of Health and Human Services, Bethesda, MD and Detroit, MI; Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI.
Perinatology Research Branch, Division of Obstetrics and Maternal-Fetal Medicine, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, US Department of Health and Human Services, Bethesda, MD and Detroit, MI; Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI; Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI; Center for Molecular Medicine and Genetics, Wayne State University, Detroit, MI; Detroit Medical Center, Detroit, MI; Department of Obstetrics and Gynecology, Florida International University, Miami, FL.
Am J Obstet Gynecol. 2020 Jul;223(1):42-65.e2. doi: 10.1016/j.ajog.2019.12.266. Epub 2020 Feb 3.
Randomized controlled trials that have assessed the efficacy of cervical pessary to prevent preterm birth in asymptomatic high-risk women have reported conflicting results.
To evaluate the efficacy and safety of cervical pessary to prevent preterm birth and adverse perinatal outcomes in asymptomatic high-risk women.
MEDLINE, EMBASE, POPLINE, CINAHL, and LILACS (from their inception to October 31, 2019), Cochrane databases, Google Scholar, bibliographies, and conference proceedings.
Randomized controlled trials that compared cervical pessary with standard care (no pessary) or alternative interventions in asymptomatic women at high risk for preterm birth.
The systematic review was conducted according to the Cochrane Handbook guidelines. The primary outcome was spontaneous preterm birth <34 weeks of gestation. Secondary outcomes included adverse pregnancy, maternal, and perinatal outcomes. Pooled relative risks with 95% confidence intervals were calculated. Quality of evidence was assessed using the GRADE methodology.
Twelve studies (4687 women and 7167 fetuses/infants) met the inclusion criteria: 8 evaluated pessary vs no pessary in women with a short cervix, 2 assessed pessary vs no pessary in unselected multiple gestations, and 2 compared pessary vs vaginal progesterone in women with a short cervix. There were no significant differences between the pessary and no pessary groups in the risk of spontaneous preterm birth <34 weeks of gestation among singleton gestations with a cervical length ≤25 mm (relative risk, 0.80; 95% confidence interval, 0.43-1.49; 6 trials, 1982 women; low-quality evidence), unselected twin gestations (relative risk, 1.05; 95% confidence interval, 0.79-1.41; 1 trial, 1177 women; moderate-quality evidence), twin gestations with a cervical length <38 mm (relative risk, 0.75; 95% confidence interval, 0.41-1.36; 3 trials, 1128 women; low-quality evidence), and twin gestations with a cervical length ≤25 mm (relative risk; 0.72, 95% confidence interval, 0.25-2.06; 2 trials, 348 women; low-quality evidence). Overall, no significant differences were observed between the pessary and no pessary groups in preterm birth <37, <32, and <28 weeks of gestation, and most adverse pregnancy, maternal, and perinatal outcomes (low- to moderate-quality evidence for most outcomes). There were no significant differences in the risk of spontaneous preterm birth <34 weeks of gestation between pessary and vaginal progesterone in singleton gestations with a cervical length ≤25 mm (relative risk, 0.99; 95% confidence interval, 0.54-1.83; 1 trial, 246 women; low-quality evidence) and twin gestations with a cervical length <38 mm (relative risk, 0.73; 95% confidence interval, 0.46-1.18; 1 trial, 297 women; very low-quality evidence). Vaginal discharge was significantly more frequent in the pessary group than in the no pessary and vaginal progesterone groups (relative risks, ∼2.20; high-quality evidence).
Current evidence does not support the use of cervical pessary to prevent preterm birth or to improve perinatal outcomes in singleton or twin gestations with a short cervix and in unselected twin gestations.
评估无症状高危女性使用宫颈托预防早产的疗效的随机对照试验报告结果相互矛盾。
评估宫颈托预防无症状高危女性早产和不良围产结局的疗效和安全性。
MEDLINE、EMBASE、POPLINE、CINAHL 和 LILACS（从其成立到 2019 年 10 月 31 日）、Cochrane 数据库、Google Scholar、参考文献和会议论文集。
比较宫颈托与标准护理（无托）或替代干预措施在无症状早产高危妇女中的随机对照试验。
系统评价按照 Cochrane 手册指南进行。主要结局是自发性早产<34 孕周。次要结局包括不良妊娠、产妇和围产结局。用 95%置信区间计算汇总相对风险。使用 GRADE 方法评估证据质量。
12 项研究（4687 名妇女和 7167 名胎儿/婴儿）符合纳入标准：8 项研究评估了宫颈短的妇女使用托 vs 无托，2 项研究评估了未选择的多胎妊娠使用托 vs 无托，2 项研究比较了宫颈短的妇女使用托 vs 阴道孕酮。在宫颈长度≤25mm 的单胎妊娠中，托与无托组自发性早产<34 孕周的风险无显著差异（相对风险，0.80；95%置信区间，0.43-1.49；6 项试验，1982 名妇女；低质量证据）、未选择的双胎妊娠（相对风险，1.05；95%置信区间，0.79-1.41；1 项试验，1177 名妇女；中等质量证据）、宫颈长度<38mm 的双胎妊娠（相对风险，0.75；95%置信区间，0.41-1.36；3 项试验，1128 名妇女；低质量证据）和宫颈长度≤25mm 的双胎妊娠（相对风险，0.72；95%置信区间，0.25-2.06；2 项试验，348 名妇女；低质量证据）。总体而言，托与无托组在早产<37 周、<32 周和<28 周，以及大多数不良妊娠、产妇和围产结局方面无显著差异（大多数结局的证据质量为低-中等）。在宫颈长度≤25mm 的单胎妊娠和宫颈长度<38mm 的双胎妊娠中，托与阴道孕酮组自发性早产<34 孕周的风险无显著差异（相对风险，0.99；95%置信区间，0.54-1.83；1 项试验，246 名妇女；低质量证据）和宫颈长度<38mm 的双胎妊娠（相对风险，0.73；95%置信区间，0.46-1.18；1 项试验，297 名妇女；极低质量证据）。托组阴道分泌物明显多于无托组和阴道孕酮组（相对风险，~2.20；高质量证据）。
目前的证据不支持使用宫颈托预防单胎或双胎妊娠的早产或改善围产结局，也不支持预防宫颈短的无症状双胎妊娠。
