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

Description

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.

Conditions

Adverse Pregnancy Outcome

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Adverse Pregnancy Outcome
Intervention / Treatment

-

Contacts and Locations

Evanston

NorthShore University HealthSystem, Evanston, Illinois, United States, 60201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NorthShore University HealthSystem,

Sunitha Suresh, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

2025-08