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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04305756
Eligibility Criteria:
Inclusion Criteria:
* Cesarean delivery
* Meet facility guidelines for postpartum venous thromboembolism (VTE) prophylaxis: Presence of 1 major, or 2 or more moderate, risk factors.
* Major risk factors: history of venous thromboembolism, high risk thrombophilia, BMI ≥40, high risk medical comorbidities (heart disease, sickle cell disease, systemic lupus erythematosus, inflammatory bowel disease), cesarean hysterectomy, nephrotic range proteinuria, or cesarean intrapartum/during labor
* Moderate risk factors: BMI \> 30, multifetal pregnancy, postpartum hemorrhage (\>1L blood loss), tobacco use, non-laboring or elective cesarean, preeclampsia, infection, preterm delivery (\< 37 weeks gestational age), age \> 35 years, low risk thrombophilia, family history of venous thromboembolism, stillbirth, varicose veins, prolonged labor (\> 24 hours)
Exclusion Criteria:
* Contraindication to anticoagulation
* Plan for therapeutic anticoagulation (antepartum or postpartum)
* Known renal dysfunction (Creatinine clearance \< 30 mL/minute)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04305756
Study Brief:
Protocol Section:
NCT04305756