RecruitingPhase 2NCT06004674

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)


Sponsor

Endeavor Health

Enrollment

20 participants

Start Date

Dec 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether a blood-thinning medication (enoxaparin/low molecular weight heparin) can help prevent complications in pregnant women who had a bad pregnancy outcome previously — such as premature birth, preeclampsia, or stillbirth — and whose placenta showed signs of poor blood flow. **You may be eligible if:** - You had a prior pregnancy complication (preterm birth, preeclampsia with severe features, low-birth-weight baby, or stillbirth) - Your previous placenta showed signs of poor blood supply (maternal vascular malperfusion) - You are currently pregnant with a single baby at less than 17 weeks **You may NOT be eligible if:** - You are already planned to take blood thinners in this pregnancy - Your baby has a known major birth defect - You are allergic to heparin or pork products, or have had a reaction to enoxaparin - You have chronic kidney disease, chronic liver disease, a low platelet count, or a mechanical heart valve Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLovenox 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.


Locations(1)

NorthShore University HealthSystem

Evanston, Illinois, United States

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NCT06004674


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