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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01729468
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Nulliparous (no previous pregnancy ≥ 22 SA)
* Singleton pregnancy
* Gestational age ≤ 15 +6 weeks
* Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm)
* Maternal informed consent obtained
* Affiliated to social security system
Exclusion Criteria:
* Women considering voluntary pregnancy termination (≤ 14 weeks)
* Pre-existing (maternal) indication for premature delivery before 37 weeks
* Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile)
* Women under anticoagulation
* Allergy or hypersensitivity to Kardegic® or one of its constituents
* Secondary hemostasis disorder responsible for bleeding or risk of bleeding
* Peptic ulcer under evolution
* Lupus or antiphospholipid syndrome
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Months
Study:
NCT01729468
Study Brief:
Protocol Section:
NCT01729468