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Recruiting NCT06004674

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

Phase II Interventional Adverse Pregnancy Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lovenox 40mg.
Who it may be relevant to
Registry conditions: Adverse Pregnancy Outcome. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

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-se

Primary outcome measures

  • Composite Adverse Pregnancy outcome [Time frame: Enrollment through 6 weeks postpartum]
Secondary outcome measures (6)
  • Maternal vascular malperfusion (MVM) [Time frame: Placenta collected at time of delivery]
  • Preeclampsia with severe features [Time frame: Enrollment through 6 weeks postpartum]
  • Small for gestational age infant [Time frame: At time of delivery]
  • Preterm delivery < 37 weeks [Time frame: Assessed at time of delivery]
  • Neonatal Death [Time frame: Assessed from time of delivery to 6 weeks postpartum]
  • Maternal Death [Time frame: Assessed from enrollment to 6 weeks postpartum]

Eligibility criteria

Eligibility Criteria:

Inclusion (must meet all three criteria):

  • 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
  • Patients with maternal vascular malperfusion on pathology from pregnancy with prior adverse pregnancy outcome, as certified by a perinatal placental pathologist
  • Current singleton pregnancy at <16 6/7 weeks gestational age.

Exclusion criteria

  • Anticoagulation planned for current pregnancy (including warfarin, enoxaparin, heparin)
  • Known major fetal anomaly
  • 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
  • Chronic kidney disease with eGFR< 60
  • Known chronic liver disease with baseline AST/ALT > 3 x upper limit of normal
  • Subjects with mechanical prosthetic heart valves

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NorthShore University HealthSystem — Evanston

Identifiers

NCT: NCT06004674 · EH22-128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗