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Background <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.</p> Methods <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 ≤ 25&#xa0;mm at 16–28&#xa0;weeks) and an emergency cohort (physical examination-indicated; painless cervical dilatation with or without membrane exposure at 16–28&#xa0;weeks). 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 &lt; 34&#xa0;weeks. RR with 95% CI was calculated as the primary measure of effect size between groups.</p> Results <p>Between June 2022 and December 2024, 100 women were enrolled and stratified (therapeutic, <i>n</i> = 50; emergency, <i>n</i> = 50). In the intention-to-treat (ITT) analysis, there was no significant difference in the primary outcome of spontaneous PTB &lt; 34&#xa0;weeks between the two-stitch and one-stitch groups in the therapeutic cohort (16.0% vs 0.0%; RR not calculable; <i>p</i> = 0.110) or the emergency cohort (40.0% vs 48.0%; RR 0.83, 95% CI 0.44–1.57; <i>p</i> = 0.569). However, an exploratory analysis of the emergency cohort revealed that the two-stitch technique was associated with a reduced incidence of PTB &lt; 28&#xa0;weeks (12.0% vs 40.0%; RR 0.30, 95% CI 0.09–0.96; <i>p</i> = 0.024). Neonatal survival rates did not differ significantly in either cohort.</p> Conclusions <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 &lt; 28&#xa0;weeks. This hypothesis-generating finding suggests a potential benefit in preventing extreme PTB &lt; 28&#xa0;weeks and must be validated in larger, definitive trials.</p> Trial registration <p>The Chinese Clinical Trial Registry (ChiCTR), Identification Number ChiCTR2200058540. https://www.chictr.org.cn/bin/project/edit?pid=159942.</p>

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Two-stitch versus one-stitch cervical cerclage in women with high risk for preterm birth: a stratified exploratory randomized controlled trial in China

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  • 发表日期：

    2026年2月16日

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  • Zhi-Min Xu,
  • Yi-Jing Zheng,
  • Wen-Xin Yan,
  • Cai-Hong Jiang,
  • Hai-Bo Li,
  • Jun Zhang,
  • Mian Pan

摘要

Background

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.

Methods

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 ≤ 25 mm at 16–28 weeks) and an emergency cohort (physical examination-indicated; painless cervical dilatation with or without membrane exposure at 16–28 weeks). 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 < 34 weeks. RR with 95% CI was calculated as the primary measure of effect size between groups.

Results

Between June 2022 and December 2024, 100 women were enrolled and stratified (therapeutic, n = 50; emergency, n = 50). In the intention-to-treat (ITT) analysis, there was no significant difference in the primary outcome of spontaneous PTB < 34 weeks between the two-stitch and one-stitch groups in the therapeutic cohort (16.0% vs 0.0%; RR not calculable; p = 0.110) or the emergency cohort (40.0% vs 48.0%; RR 0.83, 95% CI 0.44–1.57; p = 0.569). However, an exploratory analysis of the emergency cohort revealed that the two-stitch technique was associated with a reduced incidence of PTB < 28 weeks (12.0% vs 40.0%; RR 0.30, 95% CI 0.09–0.96; p = 0.024). Neonatal survival rates did not differ significantly in either cohort.

Conclusions

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 < 28 weeks. This hypothesis-generating finding suggests a potential benefit in preventing extreme PTB < 28 weeks and must be validated in larger, definitive trials.

Trial registration

The Chinese Clinical Trial Registry (ChiCTR), Identification Number ChiCTR2200058540. https://www.chictr.org.cn/bin/project/edit?pid=159942.