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Abstract：
BACKGROUND: Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT \"Stitch, Pessary, or Progesterone Randomised Trial\" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy.
RESULTS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks\' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks\' gestation. Secondary outcomes included PTB <34 weeks\', <30 weeks\', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks\' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic.
CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix.
BACKGROUND: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.
RESULTS: SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks\' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks\' gestation. Secondary outcomes included PTB <34 weeks\', <30 weeks\', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks\' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic.
CONCLUSIONS: In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix.
BACKGROUND: EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.
摘要：
背景：宫颈环扎术，宫颈子宫托,和阴道孕酮都被证明可以减少高危妇女的早产（PTB），但就我们所知,尚未对3种干预措施进行随机比较.TheSuPPoRT\"Stitch,Pessary,或孕酮随机试验旨在比较妊娠中子宫颈短的女性中每次干预之间的PTB<37周的发生率。
结果：SuppoRT是一个多中心，2015年7月1日至2021年7月1日,在英国19个产科单元进行了旨在证明等效性(等效性幅度20%)的开放标签三臂随机对照试验.无症状的单胎妊娠妇女，经阴道超声检查宫颈长度<25mm，妊娠14+0至23+6周，符合随机分组(1:1:1)接受阴道宫颈环扎术(n=128)，宫颈子宫托（n=126），或阴道孕酮（n=132）。最小化变量是招募时的妊娠，体重指数（BMI），和PTB的危险因素。主要结果是PTB<37周妊娠。次要结果包括PTB<34周，<30周\',和不良的围产期结局。分析是有意治疗。共有386名妊娠14+0至23+6周宫颈长度<25mm的孕妇被随机分配到3种干预措施之一。大约67%是白人，18%的黑人种族,和7.5％的亚洲种族。平均BMI为25.6。约85%的女性先前有PTB的危险因素;39.1%的女性经历过自发性PTB或中期妊娠(>14周妊娠);45.8%的女性曾进行过宫颈手术。来自381名女性的数据可用于结果分析。使用二元回归，发现随机疗法（环扎与子宫托与阴道孕酮）对PTB<37周的主要结局具有相似的影响（39/127对38/122对32/132，p=0.4，环扎与子宫托风险差异（RD）-0.7％[-12.1至10.7]，环扎与孕酮RD6.2%[-5.0至17.0]，孕酮与子宫托RD-6.9%[-17.9至4.1]）。同样，PTB<34周和30周没有差异，也没有不良的围产期结局。干预措施（阴道分泌物和出血）与随机接受黄体酮治疗的妇女报告的腹痛更严重之间的轻度副作用有一些差异。一小部分妇女没有按照协议接受干预；然而，符合方案和处理后的分析显示出相似的结果.主要的研究局限性是该试验对新生儿结局的影响不足，并且由于COVID-19大流行而提前停止。
结论：在这项研究中，我们发现对于子宫颈短的女性，环扎术,子宫托,和阴道孕酮在预防PTB方面同样有效，以20%的等效余量判断。开始任何治疗将是合理的临床管理。这些结果可用作临床医生在管理宫颈短的妇女时的咨询工具。
背景：欧盟临床试验注册。EudraCT编号：2015-000456-15，临床试验注册。欧盟。,ISRCTN注册表:ISRCTN13364447,isrctn.com.
结果：SuppoRT是一个多中心，2015年7月1日至2021年7月1日,在英国19个产科单元进行了旨在证明等效性(等效性幅度20%)的开放标签三臂随机对照试验.无症状的单胎妊娠妇女，经阴道超声检查宫颈长度<25mm，妊娠14+0至23+6周，符合随机分组(1:1:1)接受阴道宫颈环扎术(n=128)，宫颈子宫托（n=126），或阴道孕酮（n=132）。最小化变量是招募时的妊娠，体重指数（BMI），和PTB的危险因素。主要结果是PTB<37周妊娠。次要结果包括PTB<34周，<30周\',和不良的围产期结局。分析是有意治疗。共有386名妊娠14+0至23+6周宫颈长度<25mm的孕妇被随机分配到3种干预措施之一。大约67%是白人，18%的黑人种族,和7.5％的亚洲种族。平均BMI为25.6。约85%的女性先前有PTB的危险因素;39.1%的女性经历过自发性PTB或中期妊娠(>14周妊娠);45.8%的女性曾进行过宫颈手术。来自381名女性的数据可用于结果分析。使用二元回归，发现随机疗法（环扎与子宫托与阴道孕酮）对PTB<37周的主要结局具有相似的影响（39/127对38/122对32/132，p=0.4，环扎与子宫托风险差异（RD）-0.7％[-12.1至10.7]，环扎与孕酮RD6.2%[-5.0至17.0]，孕酮与子宫托RD-6.9%[-17.9至4.1]）。同样，PTB<34周和30周没有差异，也没有不良的围产期结局。干预措施（阴道分泌物和出血）与随机接受黄体酮治疗的妇女报告的腹痛更严重之间的轻度副作用有一些差异。一小部分妇女没有按照协议接受干预；然而，符合方案和处理后的分析显示出相似的结果.主要的研究局限性是该试验对新生儿结局的影响不足，并且由于COVID-19大流行而提前停止。
结论：在这项研究中，我们发现对于子宫颈短的女性，环扎术,子宫托,和阴道孕酮在预防PTB方面同样有效，以20%的等效余量判断。开始任何治疗将是合理的临床管理。这些结果可用作临床医生在管理宫颈短的妇女时的咨询工具。
背景：欧盟临床试验注册。EudraCT编号：2015-000456-15，临床试验注册。欧盟。,ISRCTN注册表:ISRCTN13364447,isrctn.com.
