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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03062020
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Asymptomatic singleton pregnancies, with at least one of the following: Previous spontaneous preterm delivery or a preterm premature rupture of membranes ≤ 346 weeks of gestation, Previous spontaneous second trimester miscarriage, Previous surgery on uterine cervix, Incidental finding of cervical length less than 25mm, Uterine malformations.
* Able to sign informed consent form.
Exclusion Criteria:
* Multiple pregnancies.
* Congenital, chromosomal abnormalities or stillbirth in current pregnancy.
* No patient consent to participate in the study
* Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
* Symptomatic high-risk women or preterm prelabor rupture of membranes in current pregnancy.
* Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
* Pregnant women with a short cervix detected by ultrasound and with an indication to perform a cervical cerclage, prior to study inclusion.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03062020
Study Brief:
Protocol Section:
NCT03062020