Victoria Hodgetts Morton, Philip Toozs-Hobson, Catherine A Moakes, Lee Middleton, Jane Daniels, Nigel A B Simpson, Andrew Shennan, Fidan Israfil-Bayli, Andrew K Ewer, Jim Gray, Mark Slack, Jane E Norman, Christoph Lees, Konstantinos Tryposkiadis, Max Hughes, Peter Brocklehurst, R Katie Morris
{"title":"单丝缝线与编织缝线改善阴道宫颈环扎术(C-STICH)后妊娠结局:一项实用的随机、对照、3期优势试验","authors":"Victoria Hodgetts Morton, Philip Toozs-Hobson, Catherine A Moakes, Lee Middleton, Jane Daniels, Nigel A B Simpson, Andrew Shennan, Fidan Israfil-Bayli, Andrew K Ewer, Jim Gray, Mark Slack, Jane E Norman, Christoph Lees, Konstantinos Tryposkiadis, Max Hughes, Peter Brocklehurst, R Katie Morris","doi":"10.1016/S0140-6736(22)01808-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.</p><p><strong>Methods: </strong>C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349.</p><p><strong>Findings: </strong>Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]).</p><p><strong>Interpretation: </strong>Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes.</p><p><strong>Funding: </strong>National Institute of Health Research Health Technology Assessment Programme.</p>","PeriodicalId":251261,"journal":{"name":"Lancet (London, England)","volume":" ","pages":"1426-1436"},"PeriodicalIF":0.0000,"publicationDate":"2022-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":"{\"title\":\"Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.\",\"authors\":\"Victoria Hodgetts Morton, Philip Toozs-Hobson, Catherine A Moakes, Lee Middleton, Jane Daniels, Nigel A B Simpson, Andrew Shennan, Fidan Israfil-Bayli, Andrew K Ewer, Jim Gray, Mark Slack, Jane E Norman, Christoph Lees, Konstantinos Tryposkiadis, Max Hughes, Peter Brocklehurst, R Katie Morris\",\"doi\":\"10.1016/S0140-6736(22)01808-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.</p><p><strong>Methods: </strong>C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349.</p><p><strong>Findings: </strong>Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]).</p><p><strong>Interpretation: </strong>Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. 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引用次数: 6
摘要
背景:妊娠中期流产和早产是一个重要的全球性问题。阴道宫颈环扎术是为了防止流产和早产。我们的目的是确定单丝缝合线与编织缝合线对宫颈环扎术妇女妊娠率的影响。方法:C-STICH是一项实用、随机、对照、优势试验，在英国75个产科单位进行。由于流产或早产史或超声提示而接受阴道宫颈环扎术的单胎妊娠妇女被集中随机分组(1:1)，使用最小化方法接受单丝缝合或编织缝合线进行宫颈环扎术。妇女和结果评估者尽可能不知道分配情况。主要结局是妊娠损失，定义为流产、死产或出生后第一周新生儿死亡，在意向治疗人群(即随机分配的所有妇女)中进行分析。对意向治疗人群的安全性也进行了评估。该试验已在ISRCTN注册，注册号为ISRCTN15373349。研究结果:2015年8月21日至2021年1月28日期间，2049名女性被随机分配接受单丝缝合(n=1025)或编织缝合(n=1024)。确定了1003名单丝缝合组妇女和993名编织缝合组妇女的主要结局。1003例单丝缝合组中有80例(8.0%)流产，993例编织缝合组中有75例(7.6%)流产(校正风险比1.05 [95% CI 0.79 ~ 1.40];校正风险差0.002 [95% CI - 0.02 ~ 0.03])。解释:与编织缝合相比，单丝缝合并没有降低妊娠丢失率。临床医生应使用该试验的结果来促进围绕缝线选择的讨论，以优化结果。资助:国家卫生研究所卫生技术评估方案。
Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.
Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage.
Methods: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349.
Findings: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]).
Interpretation: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes.
Funding: National Institute of Health Research Health Technology Assessment Programme.
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