Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Unicamp, Campinas, Centro Integrado de Saúde Amaury de Medeiros - CISAM-UPE, Recife, Pernambuco, the Department of Obstetrics and Gynecology, School of Medicine of Jundiaí, Jundiaí, and the Department of Obstetrics and Gynecology, Escola Paulista de Medicina, Federal University of São Paulo, São Paulo, Brazil; the Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia; and the Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, United Kingdom.
Obstet Gynecol. 2022 Jan 1;139(1):41-51. doi: 10.1097/AOG.0000000000004634.
To test the effectiveness of cervical pessary in addition to vaginal progesterone for the prevention of preterm birth in women with midpregnancy short cervixes.
We performed a multicenter, open-label, randomized controlled trial in 17 perinatal centers. Asymptomatic women with singleton or twin pregnancies and cervical lengths of 30 mm or less, measured at 18 0/7-22 6/7 weeks of gestation, were randomized to cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesterone-only group) (200 mg/day). Treatments were used from randomization to 36 weeks of gestation or delivery. The primary outcome was a composite of neonatal mortality and morbidity. Secondary outcomes were delivery before 37 weeks and before 34 weeks of gestation. Analysis was performed according to intention to treat.
Between July 9, 2015, and March 29, 2019, 8,168 women were screened, of whom 475 were randomized to pessary and 461 to progesterone only. The composite perinatal outcome occurred in 19.2% (89/463) of the women in the pessary group compared with 20.9% (91/436) of the women in the progesterone-only group (adjusted risk ratio [aRR] 0.88, 95% CI 0.69-1.12). Delivery rates before 37 weeks of gestation were 29.1% compared with 31.4% (aRR 0.86, 95% CI 0.72-1.04); delivery rates before 34 weeks were 9.9% compared with 13.9% (aRR 0.66, 95% CI 0.47-0.93). Women in the pessary group had more vaginal discharge (51.6% [245/476] vs 25.4% [117/479] [P<.001]), pain (33.1% [157/476] vs 24.1% [111/479] [P=.002]), and vaginal bleeding (9.7% [46/476] vs 4.8% [22/479] [P=.004]).
In asymptomatic women with short cervixes, the combination of pessary and progesterone did not decrease rates of neonatal morbidity or mortality when compared with progesterone only.
Brazilian Clinical Trial Registry (ReBec), UTN:U1111-1164-2636.
研究在妊娠中期宫颈短的女性中，使用宫颈托联合阴道孕酮与单纯使用阴道孕酮预防早产的效果。
我们在 17 个围产期中心进行了一项多中心、开放标签、随机对照试验。招募了妊娠 18 周零 0/7 天至 22 周零 6/7 天，宫颈长度为 30 毫米或更短且无症状的单胎或双胎妊娠女性，对其进行随机分组，一组接受宫颈托联合阴道孕酮（托加孕酮组），另一组仅接受阴道孕酮（仅孕酮组）（每天 200 毫克）。从随机分组到 36 周妊娠或分娩，两组均使用上述治疗方法。主要结局是新生儿死亡率和发病率的综合指标。次要结局为 37 周前分娩和 34 周前分娩。根据意向治疗进行分析。
2015 年 7 月 9 日至 2019 年 3 月 29 日，共有 8168 名女性接受了筛查，其中 475 名被随机分配至托加孕酮组，461 名被分配至仅孕酮组。托加孕酮组有 19.2%（89/463）的女性发生围产儿不良结局，仅孕酮组有 20.9%（91/436）（调整风险比[aRR]0.88，95%CI0.69-1.12）。37 周前的分娩率为 29.1%，而仅孕酮组为 31.4%（aRR0.86，95%CI0.72-1.04）；34 周前的分娩率为 9.9%，而仅孕酮组为 13.9%（aRR0.66，95%CI0.47-0.93）。托加孕酮组有更多的阴道分泌物（51.6%[245/476]vs25.4%[117/479]，P<.001）、疼痛（33.1%[157/476]vs24.1%[111/479]，P=.002）和阴道出血（9.7%[46/476]vs4.8%[22/479]，P=.004）。
在无症状的宫颈短的女性中，与单纯使用孕酮相比，宫颈托联合孕酮并未降低新生儿发病率或死亡率。
巴西临床试验注册处（ReBec），注册号：UTN：U1111-1164-2636。
