Preterm BirthCRAFTNCT04110704
Cerclage After Full Dilatation Caesarean Section
A study testing Insertion of transvaginal cerclage in people with Preterm Birth and Preterm Premature Rupture of Membrane, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery
- What is being tested?
- Insertion of transvaginal cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.
- Singleton pregnancy.
- Willing and able to give informed consent (with or without interpreter).
- Pregnant women up to 23+6 weeks gestation with a history of FDCS.
- Short cervix (<=25mm) on transvaginal ultrasound scan.
- Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.
Who cannot join
- Under 16 years of age.
- Inability to give informed consent.
- Previous caesarean section carried out before labour.
- Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study
- CRAFT-RCT:
- Women with persistent fresh vaginal bleeding evident on speculum examination.
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- Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.
- Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
- Known significant congenital or structural or chromosomal fetal abnormality.
- Suspected or proven rupture of the fetal membranes at the time of recruitment.
- CRAFT-IMG
- Contraindications to MRI, e.g. claustrophobia, BMI >40 kg/m2 (due to technical limitations of scanner) or a women with a non-MRI compatible metallic implant.
Trial locations and contacts
1 site in 1 country.
Michael Waring contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' Hospital NHS Foundation Trust
London, SE1 7EH
Agnieszka Glazewska-Hallin
About this study
Official title: An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth <34 weeks and <37 weeks.
CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation
CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.
- Conditions
- Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery
- Being tested
- Insertion of transvaginal cerclage
- Medical subject headings
- Premature Birth, Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of transvaginal cerclageProcedure or surgery
Transvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal cerclage | Active comparator | Not described Receives: Procedure: Insertion of transvaginal cerclage |
| Active monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
Measured: Up to 42 weeks
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation
Measured: Up to 42 weeks
Secondary outcomes (18)
CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.
We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.
Measured: Up to 48 weeks
CRAFT-OBS: Number of participants with adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services)
Measured: Up to 48 weeks
CRAFT-OBS: Number of participants who deliver <34 weeks gestation
Measured: Up to 42 weeks
CRAFT-OBS: Gestation at delivery
The proportion of participants who delivery at each gestation of completed weeks
Measured: Up to 42 weeks
CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate
Measured: Up to 42 weeks
CRAFT-OBS: Any cervical length measurements taken antenatally
Measured: Up to 42 weeks
CRAFT-OBS: Number of antenatal hospital appointments
Measured: Up to 42 weeks
CRAFT-OBS: Number of hospital admissions
Measured: Up to 42 weeks
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken
Measured: Up to 42 weeks
CRAFT-OBS: Number of ultrasound indicated antenatal interventions
Measured: Up to 42 weeks
CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks
Measured: Up to 42 weeks
CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies
COPOP core outcomes
Measured: Up to 48 weeks
CRAFT-RCT: Number of participants with an adverse perinatal outcome
Measured: Up to 48 weeks
CRAFT-RCT: Gestation at delivery
Proportion of participants who deliver at each gestation of completed weeks
Measured: Up to 42 weeks
CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)
Measured: Up to 30 weeks
CRAFT-RCT: Time between intervention and delivery.
Measured: Up to 42 weeks
CRAFT-RCT - Health costs at 28 days post-delivery.
Measured: Up to 48 weeks
CRAFT-IMG: Evidence of cervical injury
Size of any cervical lesion and its location seen on MRI or ultrasound scans
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start2 Oct 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110704
- Sponsor's protocol ID
- 261294
- Other IDs
- 42833
- Acronym
- CRAFT
- Status last verified
- Jul 2021
- First submitted
- 26 Sep 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
- ClinicalTrials.gov ID
- NCT04110704
- Acronym / sponsor ID
- CRAFT / 261294
- Conditions
- Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, University College, London
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth <34 weeks and <37 weeks.
CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation
CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal cerclage | Active comparator | Procedure: Insertion of transvaginal cerclage |
| Active monitoring | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.
- Singleton pregnancy.
- Willing and able to give informed consent (with or without interpreter).
- Pregnant women up to 23+6 weeks gestation with a history of FDCS.
- Short cervix (<=25mm) on transvaginal ultrasound scan.
Key exclusion criteria (12 listed)
- Under 16 years of age.
- Inability to give informed consent.
- Previous caesarean section carried out before labour.
- Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study
- Women with persistent fresh vaginal bleeding evident on speculum examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of transvaginal cerclageTransvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia. | Procedure or surgery | Transvaginal cerclage |
Primary outcome
CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
Time frame: Up to 42 weeks
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation
Time frame: Up to 42 weeks
18 secondary outcomes
CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.
Time frame: Up to 48 weeks
CRAFT-OBS: Number of participants with adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services)
Time frame: Up to 48 weeks
CRAFT-OBS: Number of participants who deliver <34 weeks gestation
Time frame: Up to 42 weeks
CRAFT-OBS: Gestation at delivery
Time frame: Up to 42 weeks
CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate
Time frame: Up to 42 weeks
CRAFT-OBS: Any cervical length measurements taken antenatally
Time frame: Up to 42 weeks
CRAFT-OBS: Number of antenatal hospital appointments
Time frame: Up to 42 weeks
CRAFT-OBS: Number of hospital admissions
Time frame: Up to 42 weeks
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken
Time frame: Up to 42 weeks
CRAFT-OBS: Number of ultrasound indicated antenatal interventions
Time frame: Up to 42 weeks
CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks
Time frame: Up to 42 weeks
CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies
Time frame: Up to 48 weeks
CRAFT-RCT: Number of participants with an adverse perinatal outcome
Time frame: Up to 48 weeks
CRAFT-RCT: Gestation at delivery
Time frame: Up to 42 weeks
CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)
Time frame: Up to 30 weeks
CRAFT-RCT: Time between intervention and delivery.
Time frame: Up to 42 weeks
CRAFT-RCT - Health costs at 28 days post-delivery.
Time frame: Up to 48 weeks
CRAFT-IMG: Evidence of cervical injury
Time frame: Up to 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Waring contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of transvaginal cerclage in people with Preterm Birth and Preterm Premature Rupture of Membrane, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Glazewska-Hallin (020 7188 ext. 8151, agnieszka.glazewska-hallin@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation (time frame: Up to 42 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.