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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07371520
Eligibility Criteria:
Inclusion Criteria:
* Gestational Age: Singleton pregnant women with gestational age ≥ 20 weeks.
* Clinical High-Risk Factors (meeting at least one of the following criteria):
* Traumatic Factors: Abdominal trauma (e.g., traffic accident, fall), intrauterine fetal version, amniocentesis, chorionic villus sampling (CVS).
* Obstetric Complications: Placental abruption, placenta previa, preeclampsia, unexplained antenatal hemorrhage, post-interventional therapy for twin-twin transfusion syndrome (TTTS).
* Fetal Abnormalities: Fetal growth restriction (FGR), unexplained abnormal fetal heart rate monitoring, fetal hydrops, fetal anemia (elevated middle cerebral artery peak systolic velocity (MCA-PSV) detected by Doppler ultrasound).
* High-Risk Population with Maternal-Fetal Blood Group Incompatibility: Maternal-fetal ABO or Rh-negative blood group incompatibility; positive result of the first-trimester antenatal antibody screening in pregnant women.
Exclusion Criteria:
* Pregnant women complicated with severe hematological diseases (e.g., coagulation disorders, immune thrombocytopenic purpura) or autoimmune diseases.
* Newborns who withdrew treatment for non-study-related reasons or were lost to follow-up after birth, resulting in missing outcome data.
* Termination of pregnancy due to various causes.
* Failure to complete the analysis due to unqualified core clinical data (e.g., quantitative hemorrhage test results, bilirubin levels) or unsatisfactory specimens (hemolysis, insufficient volume).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07371520
Study Brief:
Protocol Section:
NCT07371520