Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: a Pilot Project

Launched by ENDEAVOR HEALTH · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes," is exploring whether a medication called enoxaparin can help reduce the chances of having similar pregnancy problems in the future. The researchers are particularly interested in women who had a difficult previous pregnancy, like an early delivery, a stillbirth, or a baby that was smaller than expected, especially if these issues were linked to problems with blood flow in the placenta. By studying the placental tissue from past pregnancies, the team hopes to better guide treatment in current pregnancies.

To join the trial, participants need to meet certain criteria. They must have had a previous pregnancy with serious complications and have a current pregnancy that is less than 17 weeks along. Participants will be closely monitored to see if taking enoxaparin makes a difference in their pregnancy outcomes. It’s important to note that certain individuals, such as those already on blood-thinning medications or with specific health issues, may not be eligible to participate. Overall, this study aims to better understand how past placental issues can inform treatments and hopefully lead to healthier pregnancies in the future.

Gender

ALL

Eligibility criteria

• 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