C-STICH
Research type
Research Study
Full title
The Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH) Trial: A Randomised Controlled Trial of monofilament versus braided sutures for insufficient cervix.
IRAS ID
164389
Contact name
Kelly Hard
Contact email
Sponsor organisation
Birmingham Women's Hospital
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
Research Summary
The cervix is the lower end of the womb which joins the top of the vagina and is commonly called the birth canal. When women become pregnant and their baby begins to grow it starts pushing down on the entrance to the birth canal. In most women this is fine as the birth canal remains firm and closed until it’s nearly time for their baby to be born. As the date of birth approaches the birth canal softens, starts to widen and becomes shorter to allow the baby to pass through it. In some women the birth canal starts to soften, widen and shorten before the baby is ready to be born. This means that as the baby grows the birth canal may not be able to hold the baby in the womb and it may be born before its ready (prematurely). The most common treatment for a birth canal which has softened and widened too early is a technique called cervical cerclage. This is when a strong thread is stitched into the birth canal to keep it closed. Two types of thread used to place these stitches are in common usage within the NHS; monfilament (like a fishing line), and braided. Trial participants will be randomised between cerclage performed with a monofilament thread and cerclage performed with a braided thread. C-STICH will look at the nature of the thread used and record a number of important gynaecological parameters.The outcomes in each of these groups will be compared to allow gynaecologists to decide which is the best type of thread to use in women who suffer from an insufficient cervix.
Summary of Results
Cervical cerclage is an operation performed in pregnancy to prevent miscarriage and preterm birth. A cervical cerclage is sometimes recommended in women who have had babies born prematurely before or who have had previous cervical surgery.
A cerclage operation involves a stitch being inserted around the neck of the womb (cervix) to keep it closed during pregnancy and to prevent it opening prematurely. When performing the operation, the doctor can use different types of threads made of different materials. The threads used to perform the operation are called sutures. One suture type is a single strand or monofilament thread, and the other is a multifilament braided thread with lots of thin strands woven together. Some evidence has suggested that using a monofilament suture thread prevented pregnancy loss by preventing infection. Therefore, we performed a randomised controlled trial of the use of monofilament suture thread versus braided suture thread, aiming to reduce pregnancy loss in women who were having a cerclage as part of their routine care. The women consented to take part in the study and were randomly allocated to their cerclage performed with either a monofilament or braided suture thread; there was no other change to their planned pregnancy care. What happened in their pregnancy was recorded from their medical records and analysed.
A total of 2049 women agreed to take part in the study and consented to the analysis of their pregnancy and neonatal outcomes.
Cerclage suture type for an insufficient cervix and its effects on health outcomes showed that there was no difference in pregnancy loss between the two suture threads. There was decreased maternal sepsis and decreased chorioamnionitis (which is an infection inside the womb during labour) in the women who received a monofilament suture, which needs further investigation. Although more women who had a cerclage using the monofilament thread needed a small operation and an anaesthetic, often between 36 and 37 weeks, to remove the monofilament suture prior to a vaginal birth, there were no differences in the outcomes for their babies.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1293
Date of REC Opinion
4 Mar 2015
REC opinion
Further Information Favourable Opinion