Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH)
| ISRCTN | ISRCTN15373349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15373349 |
| Secondary identifying numbers | 5.0; HTA 13/04/107 |
- Submission date
- 27/11/2014
- Registration date
- 03/12/2014
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Every year about 3750 women in the UK will have complications where their cervix (the neck of the womb) becomes loose and opens during the early months of pregnancy. This can require a stitch being sewn into the cervix in an attempt to keep it closed. This is often referred to as ‘cervical suture’ or ‘cervical cerclage’. If this procedure is not performed the cervix can open too early and can result in a miscarriage or premature birth. Inserting a stitch into the cervix does not guarantee to keep the cervix closed, but it can sometimes allow the pregnancy to continue for a few more weeks. The stitches used for this procedure are available in different sizes and materials. Some of the stitch threads are made from a single, smooth fibre (e.g. nylon) while others are composed of many fibres which are woven to form a fine braided or net-like structure. A survey of consultants in the UK has shown most use braided threads when they stitch the cervix merely because it is the traditional material used and because it is thought to offer strength and enhanced support to an otherwise loose cervix. However, this survey also revealed that some surgeons thought that bacteria could grow more easily in the spaces of the braided thread than on the surface of the monofilament line. This could increase the risk of infection, which might cause an early labour. It is therefore essential to investigate whether the type of thread used for stitching the cervix increases or decreases the risk of infection. This study will therefore compare outcomes from the use of either smooth or braided stitches during this procedure.
Who can participate?
Eligible pregnant women can opt to be part of the study if they are due a planned stitch in their cervix between 12 and 22 weeks into their pregnancy.
What does the study involve?
The best way to compare the two methods of treatment is to undertake a clinical trial where the nature of the stitch used is decided randomly. Participants will be randomly allocated to receive either a monofilament suture or a braided suture to place a cervical cerclage. Apart from the type of thread used, participants will receive identical medical treatment to those not taking part in the study. Information will be collected concerning the risk of losing a baby during pregnancy or within a week of birth, the number of weeks the pregnancy lasted prior to birth, whether the baby was admitted to a Neonatal Unit, the length of stay in the unit and any sign of vaginal or womb infection.
What are the possible benefits and risks of participating?
As any participant has been advised that they will need a cervical stitch they will not gain any additional benefit by taking part in the study. Similarly, there are no additional risks associated with taking part above those associated with the cerclage itself. Seeing what bacteria grow on the vaginal swab and removed stitch will help doctors decide if the woman taking part in the study needs any antibiotics. By taking part participants will help doctors decide which is best type of thread to offer to women requiring a cervical stitch in the future. The results of this study can potentially save the lives of more than 300 babies a year in the UK alone who would otherwise be at risk of severe prematurity or miscarriage.
Where is the study run from?
Abertawe Bro Morgannwg University Health Board, Aneurin Bevan University Health Board, Barking, Havering and Redbridge University Hospitals NHS Trust, Barts Health NHS Trust, Bedford Hospital NHS Trust, Betsi Cadwaladr University Health Board, Birmingham Women’s and Children’s NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Bolton NHS Foundation Trust, Central Manchester University Hospitals NHS Trust, Chelsea and Westminster Hospital NHS Foundation Trust, City Hospitals Sunderland NHS Foundation Trust, East Lancashire Hospitals NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Heart of England NHS Foundation Trust, Imperial College Healthcare NHS Trust, Kettering General Hospital NHS Trust, Kingston Hospital NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust, Lewisham and Greenwich NHS Trust, Liverpool Women's NHS Foundation Trust, Luton and Dunstable University Hospital NHS Foundation Trust, Mid Essex Hospitals NHS Trust, Milton Keynes University Hospital NHS Foundation Trust, NHS Fife, NHS Grampian, NHS Lothian, Northern Devon Healthcare NHS Trust, Nottingham University Hospitals NHS Foundation Trust, Pennine Acute Hospitals NHS Trust, Portsmouth Hospitals NHS Trust, Princess Alexandra Hospital NHS Trust, Sandwell and West Birmingham Hospitals NHS Trust, The Mid Yorkshire Hospitals NHS Trust, The Newcastle Upon Tyne NHS Foundation Trust, The Royal Wolverhampton NHS Trust, The Shrewsbury and Telford Hospital NHS Trust, Torbay and South Devon NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, University Hospitals Bristol NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals of Leicester NHS Trust, Warrington and Halton Hospitals NHS Foundation Trust, Western Sussex Hospitals NHS Trust, Worcestershire Acute Hospitals NHS Trust, York Teaching Hospital NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
March 2015 to July 2021
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
1. Max Hughes (public)
m.hughes@bham.ac.uk
2. Mr Phil Toozs-Hobson (scientific)
Contact information
Public
Birmingham Clinical Trials Unit
Institute of Applied Health Research
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 7023 |
|---|---|
| CSTICH@trials.bham.ac.uk |
Scientific
Birmingham Women’s and Children’s Hospital NHS Foundation Trust
Birmingham Women’s Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom
Study information
| Study design | Multicentre open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.birmingham.ac.uk/Documents/college-mds/trials/bctu/C-stich/C-STICH-PIS-V4.0-23-Mar-2017-clean.doc |
| Scientific title | Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH) |
| Study acronym | C-STICH |
| Study hypothesis | Every year approximately 3750 women in the UK will have complications where their cervix (the neck of the womb) becomes loose and opens during the early months of pregnancy. This can require a stitch being sewn into the cervix in an attempt to keep it closed. This is often referred to as ‘cervical suture’ or ‘cervical cerclage’. If this procedure is not performed the cervix can open too early and can result in a miscarriage or premature birth. Inserting a stitch into the cervix does not guarantee to keep the cervix closed, but it can sometimes allow the pregnancy to continue for a few more weeks. The stitches used for this procedure are available in different sizes and materials. Some of the stitch threads are made from a single, smooth fibre (e.g. nylon) while others are composed of many fibres which are woven to form a fine braided or net-like structure. A survey of consultants in the UK has shown most use braided threads when they stitch the cervix merely because it is the traditional material used and because it is thought to offer strength and enhanced support to an otherwise loose cervix. However, this survey also revealed that some surgeons thought that bacteria could grow more easily in the spaces of the braided thread than on the surface of the monofilament line. This could increase the risk of infection which might cause an early labour. It is therefore essential to investigate whether thread-type used for stitching the cervix increases or decreases risk of infection. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1304107 Protocol can be found at http://www.birmingham.ac.uk/Documents/college-mds/trials/bctu/C-stich/CSTICH-protocol-V5.0-23-Mar-2017-clean.pdf |
| Ethics approval(s) | Cambridgeshire & Hertfordshire (East of England), 04/03/2015, ref: 14/EE/1293 |
| Condition | Insufficient cervix |
| Intervention | Participants will be randomly allocated to receive either a monofilament suture or a braided suture to place a cervical cerclage. Apart from the type of thread used, participants will receive identical medical treatment to those not taking part in the study. Information will be collected concerning the risk of losing a baby during pregnancy or within a week of birth, the number of weeks the pregnancy lasted prior to birth, whether the baby was admitted to a Neonatal Unit, the length of stay in the unit and any sign of vaginal or womb infection. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pregnancy loss rate (i.e. miscarriage and perinatal mortality, defined as any stillbirth or neonatal death in the first week of life), collected from the medical records at 7 days after delivery |
| Secondary outcome measures | Current secondary outcome measures as of 22/09/2017: Maternal outcomes, collected at discharge from hospital or 7 days, whichever is sooner: 1. Time from conception to pregnancy end (any reason) 2. Miscarriage and pre viable neonatal death (defined as delivery < 24 weeks) 3. Stillbirth (defined as interuterine death >=24 weeks) 4. Gestation at delivery (in live births >= 24 weeks) 5. Gestational age <28/<32/<37 weeks at delivery (in live births >= 24 weeks) 6. Time from conception to onset of spontaneous vaginal delivery (in live births >= 24 weeks) 7. Sepsis (at any time in pregnancy and until 7 days postnatal) 8. Preterm pre labour rupture of membranes (PPROM) 9. Gestational age at PPROM 10. Mode of initiation of labour (spontaneous or induced) 11. Mode of delivery (vaginal or operative vaginal or caesarean) 12. Cerclage placement complications (cervical laceration/bleeding from cervix/ruptured membranes/bladder injury) 13. Cerclage removal complications (cervical tears/need for anaesthetic/difficult to remove) 14. Other maternal complications: vaginal bleeding/steroid use/chorioamnionitis/maternal pyrexia of 38°C (intrapartum/postnatal)/systemic infection requiring antibiotics (intrapartum/postnatal)/admission to HDU or ITU (pre/post-delivery) 15. Serious adverse events Neonatal outcomes, collected from the medical records at 28 days for babies born at term and at the estimated delivery date for babies born preterm: 1. Early neonatal death (defined as a death within 7 days after delivery) 2. Late neonatal death (defined as a death beyond 7 days and before 28 days after delivery) 3. Birth weight adjusted for gestational age and sex (in live births >= 24 weeks) 4. Small for gestational age and sex (<10th centile; in live births >= 24 weeks) 5. Resuscitation at birth/additional care required (SCBU/NICU/HDU/transitional)/length of stay in additional care 6. Antibiotics within 72 hours/sepsis (clinically diagnosed/proven) 7. Early neurodevelopmental morbidity (severe abnormality on cranial ultrasound scan) 8. Respiratory support (ventilation/CPAP)/days on respiratory support/supplementary oxygen requirements at 36 weeks post menstrual age 9. Necrotising enterocolitis (Bell’s stage 2 or 3) 10. Retinopathy of prematurity requiring laser treatment/disabilities/congenital abnormalities 11. Serious adverse events Microbiological outcomes, measured at cerclage placement and removal: Full cultures will be undertaken to identify the complete range of potentially pathogenic bacteria isolated from the suture, and high vaginal area. The likely significance of microorganisms isolated from each clinical sample will be assessed in the context of clinical evidence of infection in the mother and her baby. Previous secondary outcome measures: Maternal: 1. Gestation at delivery 2. Mode of initiation of labour 3. Mode of delivery 4. Adverse events: suture-related cervical tears, chorioamnionitis, maternal pyrexia of 38C, systemic infection requiring antibiotics (infection parameters based on Centre for Disease Control/National Healthcare Safety Network [CDC/NHSN] guidance) Neonatal: 1. Late neonatal death, defined as a death beyond 7 days and before 28 days after delivery 2. Length of stay in neonatal unit (including level of care) 3. Severe abnormality on cranial ultrasound scan 4. Oxygen dependency at 36 weeks corrected gestation 5. Necrotising enterocolitis (Bell’s stage 2 or 3) 6. Retinopathy of prematurity requiring laser treatment Microbiological: Full cultures will be undertaken to identify the complete range of potentially pathogenic bacteria isolated from the suture and cervix. The likely significance of microorganisms isolated from each clinical sample will be assessed in the context of clinical evidence of infection in the mother and her baby. |
| Overall study start date | 01/03/2015 |
| Overall study end date | 31/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2050 |
| Total final enrolment | 2051 |
| Participant inclusion criteria | 1. Singleton pregnancy 2. Indication for cervical cerclage (any of the below): 2.1. A history of three or more previous midterm losses or premature births (≤ 28 weeks) 2.2. Insertion of cervical sutures in previous pregnancies 2.3. A history of midtrimester loss or premature birth with a shortened (≤ 25 mm) cervix 2.4. Women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan and in whom the placement of a cervical cerclage is considered the most appropriate treatment 3. Aged 18 and over |
| Participant exclusion criteria | Current exclusion criteria as of 07/06/2017: 1. Women who have taken part in C-STICH previously 2. Women aged less than 18 years old at the time of presentation 3. Those with a multiple pregnancy 4. Those requiring a rescue cerclage* 5. Women who are unwilling or unable to give informed consent 6. Those in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route) 7. Immediate need for insertion of a suture** 8. Women who have membranes that have ruptured or are surfacing*** * For study purposes, rescue cerclage is defined as: emergency cerclage where stitches are inserted in women who have had their preterm labours (e.g. uterine contractions, progressive cervical dilatation, bulging membranes) sufficiently halted by tocolysis or other means between 15 and 28 weeks. ** Immediate need for insertion of a suture should not be delayed by the trial (thus, if giving information about the trial and waiting for the participant to decide upon whether or not she wants to participate will delay the insertion of an urgently needed suture, then treatment should go ahead and the woman should be excluded from the trial). ***Woman with membranes that are ruptured or bulging through the external OS should have a rescue cerclage and be excluded from trial participation. Previous exclusion criteria: 1. Women aged less than 16 years old at the time of presentation 2. Those with a multiple pregnancy 3. Those requiring a rescue cerclage 4. Women who are unwilling or unable to give informed consent |
| Recruitment start date | 01/03/2015 |
| Recruitment end date | 31/12/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
B15 2TG
United Kingdom
EH16 4SA
United Kingdom
LS1 3EX
United Kingdom
NE1 4LP
United Kingdom
NW1 2BU
United Kingdom
W2 1NY
United Kingdom
E1 1BB
United Kingdom
NW1 2BU
United Kingdom
SE1 7EH
United Kingdom
W12 0HS
United Kingdom
SW10 9NH
United Kingdom
LS9 7TF
United Kingdom
E11 1NR
United Kingdom
M8 5RB
United Kingdom
BL4 0JR
United Kingdom
M13 9WL
United Kingdom
KY12 0SU
United Kingdom
B9 5SS
United Kingdom
FY3 8NR
United Kingdom
NN16 8UZ
United Kingdom
CV2 2DX
United Kingdom
BB10 2PQ
United Kingdom
BB2 3HH
United Kingdom
TW7 6AF
United Kingdom
E13 8SL
United Kingdom
NG7 2UH
United Kingdom
NG5 1PB
United Kingdom
L8 7SS
United Kingdom
SR4 7TP
United Kingdom
B18 7QH
United Kingdom
KT2 7QB
United Kingdom
PR2 9HT
United Kingdom
BS2 8EG
United Kingdom
TF1 6TF
United Kingdom
RM7 0AG
United Kingdom
LE1 5WW
United Kingdom
PO19 6SE
United Kingdom
NP7 7EG
United Kingdom
NP20 2UB
United Kingdom
WV10 0QP
United Kingdom
WF13 4HS
United Kingdom
WF1 4DG
United Kingdom
YO31 8HE
United Kingdom
EX31 4JB
United Kingdom
WA5 1QG
United Kingdom
SA2 8QA
United Kingdom
MK42 9DJ
United Kingdom
CM1 7ET
United Kingdom
CM20 1QX
United Kingdom
MK6 5LD
United Kingdom
AB25 2ZL
United Kingdom
TQ2 7AA
United Kingdom
SE13 6LH
United Kingdom
SE18 4QH
United Kingdom
WR5 1DD
United Kingdom
KT18 7EG
United Kingdom
SM5 1AA
United Kingdom
LU4 0DZ
United Kingdom
LL13 7TD
United Kingdom
LL18 5UL
United Kingdom
LL57 2PW
United Kingdom
PO6 3LY
United Kingdom
Sponsor information
Hospital/treatment centre
Birmingham Women’s NHS Foundation Trust
Norton Court
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
England
United Kingdom
| Website | http://www.bwnft.nhs.uk/research-developments |
|---|---|
"ROR" |
https://ror.org/00xe5zs60 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | A meeting will be held after the end of the study to allow discussion of the main results among the collaborators prior to publication. The success of the study depends entirely on the wholehearted collaboration of a large number of doctors, nurses and others. For this reason, chief credit for the main results will be given not to the committees or central organisers but to all those who have collaborated in the study. Centres will be permitted to publish data obtained from participants in the C-STICH trial that use trial outcome measures but do not relate to the trial randomised evaluation and hypothesis. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored on a secure server at Birmingham Clinical Trials Unit, with ethics and consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/09/2021 | 30/09/2021 | Yes | No |
| Results article | 22/10/2022 | 24/10/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/08/2024 | 10/09/2024 | Yes | No |
Editorial Notes
10/09/2024: Publication reference added.
24/10/2022: Publication reference added.
30/09/2021: Publication reference added.
18/08/2021: The intention to publish date has been changed from 31/08/2021 to 31/01/2022.
06/05/2021: The overall trial end date was changed from 30/06/2021 to 31/07/2021. The total final enrolment number was added.
19/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2020 to 31/12/2020.
2. The overall trial end date was changed from 30/04/2021 to 30/06/2021.
07/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 31/10/2020.
2. The overall trial end date was changed from 30/04/2021 to 30/04/2021.
3. The intention to publish date was changed from 30/06/2021 to 31/08/2021.
05/09/2019: The following changes have been made:
1. The scientific contact's details have been changed.
2. The public contact has been changed.
13/02/2019: The following changes were made:
1. The overall end date was changed from 01/10/2018 to 30/04/2021.
2. The recruitment end date was changed from 31/01/2018 to 30/06/2020.
3. The intention to publish date was changed from 31/10/2019 to 30/06/2021.
4. The total target enrolment and participant inclusion criteria: Target number of participants was changed from 900 to 2050.
22/09/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2016 to 31/01/2018.
2. The overall trial end date was changed from 01/05/2018 to 01/10/2018.
07/06/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/03/2018 to 01/05/2018.
2. The sponsor was changed from University of Birmingham to Birmingham Women’s Hospital.
11/04/2016: Ethics approval information added
