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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06385366
Eligibility Criteria:
Inclusion Criteria:
1. At recruitment, women with singleton pregnancies must fulfill the conditions:
Cases: diagnosis of Preeclampsia/eclampsia, Preterm premature rupture of membranes (PPROM)/preterm labor leading to SPB, and/or gestational diabetes mellitus.
Controls: healthy pregnancy at ≥ 37 weeks of gestation
2. History of undergoing non-invasive prenatal testing (NIPT) at 9-13 weeks 6 days of gestation at Gene Solutions Lab. NIPT report was at low-risk. No abnormal fetal and maternal conditions were confirmed at NIPT time.
3. NIPT blood sample is available according to post-test sample storage procedures at Gene Solutions Lab.
4. Consent to voluntarily participate in the study
Exclusion Criteria:
1. Multiple pregnancies
2. Pregnancy with any genetic abnormality
3. Pregnancy with any fetal structural abnormality
4. Pregnancy with indications for termination, miscarriage, or stillbirth due to other complications
5. Maternal medical history of diabetes mellitus type 1/ type 2, chronic hypertension, and chronic kidney disease. Maternal abnormal uterus anatomy and history of cervical cone biopsy sample or loop electrocautery excision procedures (LEEP).
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06385366
Study Brief:
Protocol Section:
NCT06385366