Using placental pathology to prevent recurrent pregnancy complications

Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project (UPPPP Trial)

This study is testing if a blood thinner called enoxaparin can help women who have had pregnancy complications in the past have healthier pregnancies this time around.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Endeavor Health (Academic / other)
• Locations: 1 site (Evanston, Illinois)
• Trial ID: NCT06004674 on ClinicalTrials.gov

What this trial studies

This pilot project aims to evaluate whether enoxaparin can prevent recurrent adverse pregnancy outcomes in women who have experienced complications in previous pregnancies, such as miscarriage or preeclampsia. Participants will be randomized into two groups: one receiving enoxaparin and the other receiving standard care. Blood samples will be collected at various stages of the pregnancy to monitor health and treatment effects. The study focuses on patients with maternal vascular malperfusion identified in prior pregnancies to guide treatment in subsequent pregnancies.

Who should consider this trial

Good fit: Ideal candidates are women with a history of adverse pregnancy outcomes and maternal vascular malperfusion in a previous pregnancy, currently pregnant with a singleton fetus.

Not a fit: Patients who are already on anticoagulation therapy or have contraindications to enoxaparin will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent adverse pregnancy outcomes for affected women.

How similar studies have performed: While similar approaches have been explored, this specific use of placental pathology to guide treatment in subsequent pregnancies is relatively novel.

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

Where this trial is running

Evanston, Illinois

• NorthShore University HealthSystem — Evanston, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Sunitha Suresh — Endeavor Health
• Study coordinator: Sunitha Suresh

Conditions Adverse Pregnancy Outcome; miscarriage; preeclampsia; preterm delivery; stillbirth; Low birth weight