Cerclage After Full Dilatation Caesarean Section (NCT04110704) | Clinical Trial Compass
UnknownNot Applicable
Cerclage After Full Dilatation Caesarean Section
United Kingdom1,000 participantsStarted 2019-10-02
Plain-language 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 \<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.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
CRAFT-OBS
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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:
Inclusion criteria:
* Pregnant women up to 23+6 weeks gestation with a history of FDCS.
* Short cervix (\<=25mm) on transvaginal ultrasound scan.
Exclusion criteria:
* Women with persistent fresh vaginal bleeding evident on speculum examination.
* 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
Inclusion criteria:
* Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.
Exclusion criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
Timeframe: Up to 42 weeks
2
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation