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New treatment option for Adverse Pregnancy Outcome
Official title Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
ClinicalTrials.gov ID: NCT06004674
What this study is testing
What is Lovenox 40mg?
Lovenox 40mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for adverse pregnancy outcome.
Also referred to as Enoxaparin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Eligibility Criteria: Inclusion (must meet all three criteria):
- people with a prior adverse outcome in a prior pregnancy. Adverse outcome is defined as prior singleton preterm birth ( \< 37 weeks), SGA infant...
- Patients with maternal vascular malperfusion on pathology from pregnancy with prior adverse pregnancy outcome, as certified by a perinatal placental...
- Current singleton pregnancy at \<16 6/7 weeks gestational age.
You likely can't join if
- 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...
- Chronic kidney disease with eGFR\< 60
- Known chronic liver disease with baseline AST/ALT \> 3 x upper limit of normal
- people with mechanical prosthetic heart valves
The study team makes the final eligibility decision.
Where it's taking place
- Evanston, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Evanston, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.