NCT06004674

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adverse Pregnancy Outcome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-26
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-08-22
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study