Status:
RECRUITING
Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
Lead Sponsor:
Endeavor Health
Conditions:
Adverse Pregnancy Outcome
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The goal of this randomized clinical trial is to evaluate if we can use placental pathology in a prior pregnancy which had an adverse outcome, such as early delivery, stillbirth, a baby born smaller t...
Detailed Description
In this clinical trial, participants will undergo consent, blood samples will be collected, and participants will be randomized in a 1:1 ratio to the enoxaparin or control groups at their first study ...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Inclusion (must meet all three criteria):
- Subjects with a prior adverse outcome in a prior pregnancy. Adverse outcome is defined as prior singleton preterm birth ( \< 37 weeks), SGA infant (defined as birthweight \< 10th percentile), preeclampsia with severe features, or stillbirth (fetal demise after 20 weeks gestation), as certified by an obstetrician
- Patients with maternal vascular malperfusion on pathology from pregnancy with prior adverse pregnancy outcome, as certified by a perinatal placental pathologist
- Current singleton pregnancy at \<16 6/7 weeks gestational age.
- Exclusion Criteria:
- Anticoagulation planned for current pregnancy (including warfarin, enoxaparin, heparin)
- Known major fetal anomaly
- Contraindication to enoxaparin: Specifically active major bleeding, known thrombocytopenia (platelets \<100), hypersensitivity to enoxaparin sodium, hypersensitivity to heparin or pork products, hypersensitivity to benzyl alcohol
- Chronic kidney disease with eGFR\< 60
- Known chronic liver disease with baseline AST/ALT \> 3 x upper limit of normal
- Subjects with mechanical prosthetic heart valves
Exclusion
Key Trial Info
Start Date :
December 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06004674
Start Date
December 26 2023
End Date
March 1 2026
Last Update
July 31 2025
Active Locations (1)
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1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201