Recruiting
Phase 2

Observational Study

Sponsor:

Endeavor Health

Code:

NCT06004674

Conditions

Adverse Pregnancy Outcome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Lovenox 40mg

Study Details

Brief 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.

Conditions

Adverse Pregnancy Outcome

Study ID

NCT06004674

Start date

Dec 26, 2023

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enoxaparin Group

Participants in the enoxaparin group will be asked to take a dose of the enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or start of enrollment (whichever is later), and continue until 36 weeks gestational age, after which enoxaparin will be discontinued.

no intervention: Control Group

Participants in this group will have standard care as usual, with no additional medications.

Interventions

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-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.

Primary outcome measure

  • Composite Adverse Pregnancy outcome [ Time Frame: Enrollment through 6 weeks postpartum ]

Central Contacts and Locations

Locations

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

More Information

Sponsor

Endeavor Health

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • miscarriage
  • preeclampsia
  • preterm delivery
  • stillbirth
  • Low birth weight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-07-23.