{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:37:11Z","timestamp":1792787831046,"version":"4.5.0"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T00:00:00Z","timestamp":1771200000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T00:00:00Z","timestamp":1774310400000},"content-version":"vor","delay-in-days":36,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"the Joint Funds for the innovation of science and Technology\uff0cFujian province","award":["2024Y9556"],"award-info":[{"award-number":["2024Y9556"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Pregnancy Childbirth"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cervical insufficiency or sonographic short cervix is a major cause of preterm birth (PTB). The efficacy of two-stitch versus one-stitch cerclage remains controversial, with limited evidence from randomized controlled trial (RCT), especially stratified by indication.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a single-centre, stratified, exploratory RCT at Fujian Maternal and Child Health Hospital, Fuzhou, China. Women with singleton pregnancies were enrolled into two parallel cohorts: a therapeutic cohort (ultrasound-indicated; cervical length\u2009\u2264\u200925\u00a0mm at 16\u201328\u00a0weeks) and an emergency cohort (physical examination-indicated; painless cervical dilatation with or without membrane exposure at 16\u201328\u00a0weeks). Within each cohort, participants were randomly assigned (1:1) to receive McDonald cerclage with either two-stitch or one-stitch. The primary outcome was spontaneous PTB\u2009&lt;\u200934\u00a0weeks. RR with 95% CI was calculated as the primary measure of effect size between groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between June 2022 and December 2024, 100 women were enrolled and stratified (therapeutic,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200950; emergency,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200950). In the intention-to-treat (ITT) analysis, there was no significant difference in the primary outcome of spontaneous PTB\u2009&lt;\u200934\u00a0weeks between the two-stitch and one-stitch groups in the therapeutic cohort (16.0% vs 0.0%; RR not calculable;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.110) or the emergency cohort (40.0% vs 48.0%; RR 0.83, 95% CI 0.44\u20131.57;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.569). However, an exploratory analysis of the emergency cohort revealed that the two-stitch technique was associated with a reduced incidence of PTB\u2009&lt;\u200928\u00a0weeks (12.0% vs 40.0%; RR 0.30, 95% CI 0.09\u20130.96;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.024). Neonatal survival rates did not differ significantly in either cohort.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In the therapeutic setting, the two-stitch technique was not superior to the one-stitch approach. For emergency cerclage, while the primary outcome was not significantly reduced, a secondary analysis showed an association between the two-stitch technique and a reduced incidence of extreme PTB\u2009&lt;\u200928\u00a0weeks. This hypothesis-generating finding suggests a potential benefit in preventing extreme PTB\u2009&lt;\u200928\u00a0weeks and must be validated in larger, definitive trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>The Chinese Clinical Trial Registry (ChiCTR), Identification Number ChiCTR2200058540. https:\/\/www.chictr.org.cn\/bin\/project\/edit?pid=159942.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12884-026-08809-8","type":"journal-article","created":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T10:45:24Z","timestamp":1771238724000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Two-stitch versus one-stitch cervical cerclage in women with high risk for preterm birth: a stratified exploratory randomized controlled trial in China"],"prefix":"10.1186","volume":"26","author":[{"given":"Zhi-Min","family":"Xu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi-Jing","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Xin","family":"Yan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cai-Hong","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hai-Bo","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1509-9499","authenticated-orcid":false,"given":"Jun","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1698-4994","authenticated-orcid":false,"given":"Mian","family":"Pan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,16]]},"reference":[{"issue":"6","key":"8809_CR1","volume":"6","author":"Z Alfirevic","year":"2017","unstructured":"Alfirevic Z, Stampalija T, Medley N. 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Written informed consent was obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"316"}}