Altmetric

C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes-a multicentre randomised controlled trial

Title: C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes-a multicentre randomised controlled trial
Authors: Israfil-Bayli, F
Morton, VH
Hewitt, CA
Ewer, AK
Gray, J
Norman, J
Lees, C
Simpson, NAB
Shennan, A
Tryposkiadis, K
Hughes, M
Daniels, J
Brocklehurst, P
Morris, K
Middleton, L
Toozs-Hobson, P
Item Type: Journal Article
Abstract: Background Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. Methods A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. Discussion Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates.
Issue Date: 28-Sep-2021
Date of Acceptance: 15-Sep-2021
URI: http://hdl.handle.net/10044/1/92260
DOI: 10.1186/s13063-021-05629-3
ISSN: 1745-6215
Publisher: BioMed Central
Journal / Book Title: Trials
Volume: 22
Issue: 1
Copyright Statement: © The Author(s) 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Obstetrics and gynaecology
Preterm birth
Cervical cerclage
Cervical cerclage
Obstetrics and gynaecology
Preterm birth
Adolescent
Cerclage, Cervical
Cervix Uteri
Female
Humans
Infant, Newborn
Outcome Assessment, Health Care
Pregnancy
Premature Birth
Sutures
Cervix Uteri
Humans
Premature Birth
Cerclage, Cervical
Sutures
Pregnancy
Adolescent
Infant, Newborn
Female
Outcome Assessment, Health Care
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Obstetrics and gynaecology
Preterm birth
Cervical cerclage
General & Internal Medicine
Cardiovascular System & Hematology
1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
Publication Status: Published
Article Number: ARTN 664
Appears in Collections:Department of Metabolism, Digestion and Reproduction



This item is licensed under a Creative Commons License Creative Commons