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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07372495
Eligibility Criteria:
Inclusion Criteria:
* Maternal age ≥ 18
* Twin pregnancy
* Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
* Gestational age at 16+0- 24+0 weeks
Exclusion Criteria:
A potential paticipant who meets any of the following criteria will be excluded from participation in this trial:
* Women with twin pregnancy in which one or both fetuses are diagnosed with a major structural or congenital abnormality that is likely to influence the composite adverse neonatal outcome.
* Women with a monochorionic monoamniotic twin pregnancy
* A monochorionic twin pregnancy with twin-to-twin transfusion syndrome before or at the time of inclusion.
* Patients have indications for vaginal cerclage: Recurrent late miscarriage (from 14 weeks) or preterm birth occurring two or more times.
* Women with dilatation of the cervix diagnosed by ultrasound or physical exam
* Women with overt symptoms of preterm labor at the time of measurement of the short cervix (regular contractions, PPROM, recurrent blood loss).
* Women with the presence of fever ≥ 38 degrees Celsius.
* Women with a placenta previa, vasa previa.
* Uterine malformations: unicornuate uterus, bicornuate uterus, uterine septum, fibroid…
* Severe maternal conditions (heart failure, chronic kidney disease, systemic lupus erythematosus …)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07372495
Study Brief:
Protocol Section:
NCT07372495