Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
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 than expected, or severe forms of high blood pressure during pregnancy, to guide treatment in the subsequent pregnancy and reduce risk of recurrent adverse pregnancy events. The main questions it aims to answer are: * Whether enoxaparin prevents recurrent adverse pregnancy outcomes among patients with a prior adverse pregnancy outcome that occurred in the setting of maternal vascular malperfusion (MVM). * If enoxaparin reduces the occurrence or severity of MVM among patients with a prior adverse pregnancy outcome that occurred in the setting of MVM.
Conditions:
🦠 Adverse Pregnancy Outcome
🗓️ Study Start (Actual) 26 December 2023
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) August 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Evanston, Illinois, United States

📋 Eligibility Criteria

Description

  • Eligibility Criteria:
  • Inclusion (must meet all three criteria):
  • 1. 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
  • 2. Patients with maternal vascular malperfusion on pathology from pregnancy with prior adverse pregnancy outcome, as certified by a perinatal placental pathologist
  • 3. Current singleton pregnancy at \<16 6/7 weeks gestational age.

Exclusion Criteria:

  • 1. Anticoagulation planned for current pregnancy (including warfarin, enoxaparin, heparin)
  • 2. Known major fetal anomaly
  • 3. 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
  • 4. Chronic kidney disease with eGFR\< 60
  • 5. Known chronic liver disease with baseline AST/ALT \> 3 x upper limit of normal
  • 6. Subjects with mechanical prosthetic heart valves
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 August 2023
  • First Submitted that Met QC Criteria 15 August 2023
  • First Posted 22 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 January 2024
  • Last Update Posted 23 January 2024
  • Last Verified January 2024