ABOVE: Cerclage after Caesarean

Plain English Summary

Background and study aims
Recent studies have shown that if a woman has had a caesarean section in labour (when the cervix is opening) she is more likely to have a premature baby in a future pregnancy. In women who have had an in-labour caesarean section there is a 5-10% chance of a preterm birth in a subsequent pregnancy.
For women who have had an in-labour caesarean section, which was then followed by a preterm birth or mid-trimester loss, early birth is even more likely in subsequent pregnancies. Currently it is not known which treatments are most effective to stop this happening.
These women should be referred to specialist preterm clinics, which will offer them ultrasound monitoring of the length of their cervix, and they may or may not also be offered a cervical cerclage, although there are currently no national guidelines about this. This is a small surgical procedure where a stitch is placed around the cervix through the vagina (transvaginal cerclage). A cerclage can also be placed higher up, through an abdominal procedure involving a cut in the tummy (transabdominal cerclage). This procedure is a longer operation with more recovery time and means that any future babies will need to be born by caesarean section.
Both types of cerclage are offered as standard care to women at high risk of preterm birth. Although transvaginal cerclages are more straightforward, transabdominal cerclages might be more effective because they are above any damage that might have been caused during a previous caesarean section.

Who can participate?
Women who have had a preterm birth or mid-trimester loss (a loss between 14 and 24 weeks of pregnancy) after a previous caearean section in labour

What does the study involve?
Participants will be allocated to one of two treatments: a vaginally-placed cervical stitch or an abdominally-placed cervical stitch, performed before 14 weeks of pregnancy. Some women will join the study before pregnancy, in this group the abdominally-placed stitch will be sited before they get pregnant and the vaginal stitch before 14 weeks in the next pregnancy.
With both stitches participants are followed up in a prematurity clinic with regular transvaginal scanning. If the cervix becomes short participants may be admitted to hospital or offered other treatments (such as a steroid injection to help the baby’s lungs mature, and/or putting in an additional stitch if the cervix opens). These may be offered if there is a high chance the baby may be born very early.
The researchers will ask your permission to look at participants' medical notes after delivery to find out what happened. They may also save some scan images of the cervix taken in the prematurity clinic.

What are the possible benefits and risks of participating?
Taking part in the study may not have any direct benefit to participants now. However, the results of this study might help to improve care in any future pregnancies as well as other women, and to reduce the number of babies being born too early.
Having a cervical stitch inserted is a relatively common procedure and is known to help some women. Risks of both treatments include post-operative pain, infection and bleeding. The uncommon risks (occurring in 1 out of 1000) include tearing of the cervix or bladder. The obstetrician would generally be able to repair any tearing to the cervix immediately. A tear to the bladder would require another operation by a urologist (a medical doctor with specialist training in problems of the urinary tract). Both would require a few extra days in hospital. If the doctor is worried about infection, a swab may be taken from the vagina and, if there is evidence of infection, participants may be given a course of antibiotics. While it is likely that either of the cerclages will reduce the chance of miscarriage or preterm birth, they will not entirely eliminate the possibility.

Where is the study run from?
St Thomas' Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2023 to October 2026

Who is funding the study?
1. Action Research Medical (UK)
2. Borne (UK)

Who is the main contact?
above-study@kcl.a.c.uk

Contact information

Prof Andrew Shennan
Public, Scientific

Women's and Children's Department
10th Floor
St Thomas Hospital Westminster
Bridge Road
London
SE1 7EH
United Kingdom

ORCID ID	0000-0001-5273-3132
Phone	+44 (0)20 7188 7188
Email	andrew.shennan@kcl.ac.uk

Dr Laura van der Krogt
Public, Scientific

Women's and Children's Department
10th Floor
St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

ORCID ID	0009-0004-2040-0375
Phone	+44 (0)20 7188 7188
Email	laura.c.van_der_krogt@kcl.ac.uk

Dr Jenny Carter
Public, Scientific

Women's and Children's Department
10th Floor
St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 7188
Email	jenny.carter@kcl.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

King's College London
Hospital/treatment centre

Strand
London
WC2R 2LS
England
United Kingdom

Phone	+44 (0)2078487306
Email	vpri@kcl.ac.uk
Website	http://www.kcl.ac.uk/index.aspx
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

Results and Publications

Study outputs

Additional files

45491_PIS_GroupA_v3.0.pdf

Group A

45491_PIS_GroupB_v3.0.pdf

Group B

Editorial Notes

17/05/2024: Study's existence confirmed by the NIHR.