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.
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.
| Original language | English |
|---|---|
| Pages (from-to) | 1426-1436 |
| Number of pages | 11 |
| Journal | The Lancet |
| Volume | 400 |
| Issue number | 10361 |
| Early online date | 20 Oct 2022 |
| DOIs | |
| Publication status | Published - 22 Oct 2022 |
Bibliographical note
Funding Information:VHM is a National Institute for Health and Care Research (NIHR) clinical lecturer and has received an honorarium from Hologic. JD reports membership of the NIHR Clinical Trials Unit Standing Advisory Committee (May 1, 2016, to Sept 30, 2023). JEN is a member of the Health Technology Assessment (HTA) Maternal, Neonatal and Child Health Panel; receives funding from NIHR Efficacy and Mechanism Evaluation programme; participates in a Data Monitoring and Ethics Committee for GlaxoSmithKline; and is a paid consultant for DILAFOR. RKM receives funding from NIHR HTA and programme grants for Applied Health Research schemes; is a steering committee member of the Saving Babies Lives Care Bundle; and a paid Clinical Advisory Board member for Surepulse (a company designing neonatal monitors). All other authors declare no competing interests.
Funding Information:
This study was funded by the National Institute of Health Research Health Technology Assessment Programme (award 13/04/107).
Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license