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RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 sites (1)

IL