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Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
NCT06004674 · Endeavor Health
In plain English
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Official title
Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project (UPPPP Trial)
About this study
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 visit.
* Participants will return for a study visit within 1 week following randomization.
* If assigned to the enoxaparin, the participant will be asked to take a dose of the enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or the start of enrollment (whichever is later) and continue until 36 weeks gestational age, after which enoxaparin will be discontinued.
* Participants in the control group will have care as usual, with no additional medications.
* During this study, a study team member will collect a blood sample from all participants at 20-24 weeks, 32-34 weeks, and at delivery.
* Participants in the enoxaparin group will have their blood work checked a week after starting medication to ensure that they have no unanticipated side effects.
Researchers will compare the enoxaparin group to the control group to see if enoxaparin prevents or reduces the occurrence or severity of maternal vascular malperfusion (MVM) among patients with a prior adverse pregnancy outcome.
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
Study design
Enrollment target: 20 participants
Allocation: randomized
Masking: single
Age groups: adult
Timeline
Starts: 2023-12-26
Estimated completion: 2026-03
Last updated: 2025-07-31
Interventions
Drug: Lovenox 40mg
Primary outcomes
- • Composite Adverse Pregnancy outcome (Enrollment through 6 weeks postpartum)
Sponsor
Endeavor Health · other
Contacts & investigators
ContactSunitha Suresh · contact · SSuresh@northshore.org · (847) 570-2860
ContactKate Honeyfield · contact · KHoneyfield@northshore.org · 847-570-2243
InvestigatorSunitha Suresh · principal_investigator, Endeavor Health
All locations (1)
NorthShore University HealthSystemRecruiting
Evanston, Illinois, United States