Recruiting

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

ClinicalTrials.gov IDNCT06004674

PhasePHASE2

Enrollment20

SponsorEndeavor Health

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Adverse Pregnancy Outcome

About this study

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.

Interventions

Drug: Lovenox 40mg — Enoxaparin is a blood thinner. It is approved for use in the prevention of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness; inpatient treatment of acute DVT with or without pulmonary embolism; outpatient treatment of acute DVT without pulmonary embolism; Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction; treatment of acute ST-segment elevation myocardial infarction(STEMI) managed medically or with subsequent percutaneous coronary intervention. The use of Lovenox has been shown to be safe, and it has also been used widely off-label in pregnancy.

Primary outcomes

Composite Adverse Pregnancy outcome (Enrollment through 6 weeks postpartum)

Eligibility information

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

Study locations

NorthShore University HealthSystem, Evanston, Illinois 60201 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.