Plain English Summary
Background and study aims
A cervical cerclage is the placement of a stitch to keep the neck of the womb (cervix) closed. A stitch can be placed in a planned way because of a perceived risk of premature birth based on a woman’s pregnancy history or because the neck of the womb is shorter than normal on an ultrasound scan but still closed. Sometimes the neck of the womb can start to open early and the bag of water around the baby (amniotic sac) can come through the neck of womb. If this happens between 16 and 28 weeks of pregnancy an emergency rescue stitch can be performed to try and delay delivery. Prolonging the pregnancy so that the baby can be born when they are bigger and stronger may give them a better chance of surviving and suffering from fewer complications of prematurity. Doctors do not know if a rescue cerclage works. There is some evidence it may prolong pregnancy but it is possible that it may also speed up delivery by causing infection or cause damage to the neck of the womb of the mother. It is therefore very important to perform a study to decide if rescue cerclages delay delivery and if it does whether this benefits the baby (and mother). The best way to work out if rescue cerclage works, and is safe, is to ask women to be randomly allocated to the treatment. This is what we need to do to ensure we know what is best for future women and babies to prevent harm. This study will ask women who have an open neck of the womb with the bag of waters around the baby coming through, to have either a rescue stitch or no rescue stitch the treatment arm will be decided by a process that randomly allocate to one group or the other. All women in the study irrespective of the allocated group will be able to have other treatments that may help prolong pregnancy such as antibiotics, progesterone and medicines that stop the womb contracting (although none of these have been proven to delay labour or improve health of babies). The study team will collect what happens to the mum and baby from their medical notes. All babies will also be reviewed at 2 years of age to assess how they are developing by a postal questionnaire completed by the parents.
Who can participate?
Women who have an open neck of the womb with the bag of waters around the baby coming through at 16-27 weeks of pregnancy..
What does the study involve?
Women will be randomly allocated to receive the stitch or not. All women in the study, whether they have the stitch or not, will be able to have other treatments that may help prolong pregnancy such as antibiotics, progesterone and medicines that stop the womb contracting (although none of these have been proven to delay labour or improve health of babies).
What are the possible benefits and risks of participating?
Risks relating the the rescue cervical cerclage will be detailed to you by the doctor looking after you, but include infection, bleeding, failure to perform the procedure, and rupture of the membranes around your baby leading to delivery of the baby. The potential benefit of rescue cervical cerclage in terms of prolonging pregnancy is not known.
Where is the study run from?
Birmingham Women's Hospital
When is the study starting and how long is it expected to run for?
July 2018 to October 2024
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Kiran Sunner, K.K.Sunner@bham.ac.uk
(updated 12/04/2021, previously: Dr Katie Morris, r.k.morris@bham.ac.uk)
Study website
Contact information
Type
Scientific
Contact name
Mr Kirandeep Sunner
ORCID ID
Contact details
Birmingham Clinical Trials Unit
Institute of Applied Health Research
Public Health Building
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4159100
K.K.Sunner@bham.ac.uk
Additional identifiers
EudraCT/CTIS number
2012-005627-32
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
C-STICH2: Rescue cervical cerclage to prevent miscarriage and preterm birth: A randomised controlled, multicentre trial (RCT) with internal pilot, a nested qualitative study and cost-effectiveness analysis.
Acronym
C-STICH2
Study hypothesis
Does a rescue cervical cerclage prolong pregnancy when performed at 16-28 weeks at amniotic sac prolapse?
Ethics approval(s)
We anticipate submitting for ethics approval on 01/08/2018.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available at time of registration
Condition
Obstetrics: Mid Trimester Miscarriage and Preterm Birth
Intervention
Women will be randomised via a web based application provided by the Birmingham Clinical Trials Unit.
Women will be randomised to rescue cerclage, an emergency cervical cerclage performed as quickly as feasible, or expectant management which will be pragmatic and involve other treatment at the discretion on the clinician caring for the women.
Intervention type
Procedure/Surgery
Primary outcome measure
Pregnancy loss rate (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life )
Secondary outcome measures
Maternal (from medical records):
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 (from medical records):
16. Early neonatal death (defined as a death within 7 days after delivery )
17. Late neonatal death (defined as a death beyond 7 days and before 28 days after delivery)
18. Birth weight adjusted for gestational age and sex (in live births >= 24 weeks)
19. Small for gestational age and sex (<10th centile; in live births >= 24 weeks)
20. Resuscitation at birth/additional care required (SCBU/NICU/HDU/transitional)/length of stay in additional care
21. Antibiotics within 72 hours/sepsis (clinically diagnosed/proven)
22. Early neurodevelopmental morbidity (severe abnormality on cranial ultrasound scan)
23. Respiratory support (ventilation/CPAP)/days on respiratory support/supplementary oxygen requirements at 36 weeks post-menstrual age
24. Necrotising enterocolitis (Bell’s stage 2 or 3)
25. Retinopathy of prematurity requiring laser treatment/disabilities/congenital abnormalities
26. Serious adverse events
Infant (from medical records):
27. Infant death after 28 days until 21 years
Child (2-year outcomes collected through a general health questionnaire and PARCA-R):
28. Non-verbal cognition
29. Linguistic skills (from vocabulary and sentence complexity sub-scales)
30. Parent report composite score (from 1 and 2)
Overall study start date
01/07/2018
Overall study end date
31/10/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 16 years or older
2. Cervical dilatation with exposed, unruptured foetal membranes
3. Singleton pregnancy
4. Gestational age 16+0 to 27+6 weeks
5. Able to give informed written consent
Participant type(s)
Patient
Age group
Adult
Lower age limit
16 Years
Sex
Female
Target number of participants
260
Participant exclusion criteria
1. Contraindication to rescue cerclage as judged by the clinician
2. Cervical cerclage (vaginal or abdominal) inserted earlier in this pregnancy
Recruitment start date
01/01/2019
Recruitment end date
31/10/2024
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Katie Morris
Birmingham Women's Hospital
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Birmingham Women's and Children's NHS foundation trust.
Sponsor details
Mindelsohn Way
Birmingham B15 2TG
birmingham
b152TG
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
https://bwc.nhs.uk/birmingham-womens-hospital
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
01/06/2025
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
K.K.Sunner@bham.ac.uk
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | 11/08/2021 | 26/09/2023 | Yes | No |