Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT04110704
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT04110704
Study Brief:
Protocol Section:
NCT04110704