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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03528967
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years and
* Age ≤ 45 years and
* Single and confirmed pregnancy and
* Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) \< 3rd percentile and / or
* In utero fetal death (IUFD) history \> 12 weeks of amenorrhea (WA) and / or
* Central Retroplacental hematoma (RPH) history \< 34 WA and / or
* History of severe preeclampsia \< 34 WA and
* Informed consent, written and obtained
Exclusion Criteria:
* Age \<18 years or
* Age \> 45 years or
* Multiple pregnancy or
* Pregnancy \> 7 WA or
* Positive immunological assessment or
* Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or
* Anticoagulation required or
* Thrombocythaemia \< 100,000 plq / µl or
* Weight \> 100 kg or
* Osteoporosis or
* Known allergy to the study products or
* Inability to ensure injections' administration or
* Family history of DVT before 40 years of age or
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03528967
Study Brief:
Protocol Section:
NCT03528967