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Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial

Hodgetts Morton, Victoria; Toozs-Hobson, Philip; Moakes, Catherine A.; Middleton, Lee; Daniels, Jane; Simpson, Nigel A.B.; Shennan, Andrew; Israfil-Bayli, Fidan; Ewer, Andrew K.; Gray, Jim; Slack, Mark; Norman, Jane E.; Lees, Christoph; Tryposkiadis, Konstantinos; Hughes, Max; Brocklehurst, Peter; Morris, R. Katie

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial Thumbnail


Authors

Victoria Hodgetts Morton

Philip Toozs-Hobson

Catherine A. Moakes

Lee Middleton

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



Abstract

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.

Citation

Hodgetts Morton, V., Toozs-Hobson, P., Moakes, C. A., Middleton, L., Daniels, J., Simpson, N. A., …Morris, R. K. (2022). Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial. Lancet, 400(10361), 1426-1436. https://doi.org/10.1016/S0140-6736%2822%2901808-6

Journal Article Type Article
Acceptance Date Oct 11, 2022
Online Publication Date Oct 20, 2022
Publication Date Oct 22, 2022
Deposit Date Nov 21, 2022
Publicly Available Date Nov 24, 2022
Journal The Lancet
Print ISSN 0140-6736
Electronic ISSN 1474-547X
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 400
Issue 10361
Pages 1426-1436
DOI https://doi.org/10.1016/S0140-6736%2822%2901808-6
Public URL https://nottingham-repository.worktribe.com/output/12902353
Publisher URL https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01808-6/fulltext