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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00198068
Eligibility Criteria:
Inclusion Criteria:
* Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)
* Patient between the ages of 18-45 and able to give informed consent, or age \< 18 years with parental consent
* Hematocrit \> 26%
* For APL positive:
* aCL: IgG \>= 40 GPL units; IgM \>= 40 MPL units
* Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)
* Anti-β2GPI: IgG \>= 40 GPL units; IgM \>= 40 MPL units
* For control subjects:
* At least one successful pregnancy
* No history of fetal death (death of conceptus ≥ 10 weeks' gestation)
* No more than 1 miscarriage \< 10 weeks' gestation
* No history of positive aPL in local lab or positive aPL in core labs at screening
* Not currently a smoker
* No medical problems requiring chronic treatment
Exclusion Criteria:
* Diabetes mellitus (Type I and Type II) antedating pregnancy
* Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00198068
Study Brief:
Protocol Section:
NCT00198068