The C-STICH & C-STICH 2 Trials

Research trials comparing the effectiveness of cervical stitches, and the best types of stitches, to delay preterm labour.

 

The C-STICH study, supported by Sands, aimed to find out which type of stitch works best for delaying preterm births and reducing the risks of worse outcomes for mother and baby associated with preterm birth. The study compared smooth and braided stitches used to keep the cervix closed when trying to delay preterm labour. The main findings showed that smooth stitches did not reduce the rate of pregnancy loss compared to braided stitches. This information can help doctors decide which type of stitch to use for cervical cerclage, and help mothers make better informed choices in these situations.

Following the C-STICH study, the C-STICH 2 study is now underway to learn more about the overall safety and effectiveness of using stitches to delay preterm labour and reduce baby deaths. Sands has been involved in supporting both studies.

 

The full scientific paper for C-STICH is available here.

Here is a link to the C-STICH2 website.

More information

Why is this research important?

Early births and pregnancy loss are significant global issues. Many women experience complications during pregnancy where the cervix starts to open too early, possibly leading to miscarriage or premature birth. Cervical cerclage is a procedure where a stitch is placed around the cervix to keep it closed and prevent further opening. However, it's not clear which type of stitch works best at delaying early births and reducing pregnancy loss. Sands supports research like this to help save babies' lives and improve outcomes for affected families.

 

What are the aims of this study?

The C-STICH study aimed to compare how well smooth and braided stitches work in preventing preterm births once the cervix has begun to open too early. Building on the findings of the C-STICH study, the C-STICH 2 study is now focusing on understanding whether using stitches in emergency situations is safe and effective for delaying preterm birth and reducing baby deaths.

 

What did the researchers do?

The C-STICH study worked with 75 hospitals in the UK. They randomly placed 2,049 pregnant women who needed a cervical cerclage into two groups, one group receiving a smooth stitch and the other a braided stitch. Sands played an active role in the research, providing input and support for the study.

The C-STICH 2 study is currently reviewing existing research to learn more about the overall effectiveness of rescue cervical cerclage in delaying preterm birth. The study is looking at the safety and usefulness of this treatment for women who show signs of early cervical opening before 28 weeks of pregnancy.

 

What can we learn from these studies?

The C-STICH study showed that smooth stitches did not prevent preterm labour from starting any more effectively than braided stitches. This information can help doctors decide which type of stitch to use for cervical cerclage, improving outcomes for both mother and baby. It also raises bigger questions about the overall effectiveness of cervical stitches in delaying preterm labour, which is C-STICH 2 is now testing. It aims to provide further insights into the safety and effectiveness of cervical stitches, which could lead to better and more personalised treatment options for women at risk of preterm birth.

 

Additional information:

Lead researcher – Philip Toozs-Hobson

Institution – University of Birmingham

Funder – NIHR

Duration –  2017 - ongoing

 

Publications:

C-STICH

Hodgetts Morton, V. et al. (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’, The Lancet, 400(10361), pp. 1426–1436. Available at: https://doi.org/10.1016/S0140-6736(22)01808-6

C-STICH2

Pilarski, N., Hodgetts-Morton, V. and Morris, R.K. (2021) ‘Is cerclage safe and effective in preventing preterm birth in women presenting early in pregnancy with cervical dilatation?’, BMJ, 375, p. e067470. Available at: https://doi.org/10.1136/bmj-2021-067470.

Find out more about what we do and our plans for the future in our research strategy.
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