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

NCT06004674 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EH22-128
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite Adverse Pregnancy outcome

  Preeclampsia with severe features, small for gestational age infant, preterm delivery \<37 weeks, neonatal death, and maternal death

  Enrollment through 6 weeks postpartum

Secondary Outcomes (6)

• Maternal vascular malperfusion (MVM)

  Placenta collected at time of delivery

• Preeclampsia with severe features

  Enrollment through 6 weeks postpartum

• Small for gestational age infant

  At time of delivery

• Preterm delivery < 37 weeks

  Assessed at time of delivery

• Neonatal Death

  Assessed from time of delivery to 6 weeks postpartum

Study Arms (2)

Enoxaparin Group

EXPERIMENTAL

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.

Drug: Lovenox 40mg

Control Group

NO INTERVENTION

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

Interventions

Lovenox 40mg DRUG

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.

Also known as: Enoxaparin

Enoxaparin Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This study will specifically recruit patients who are pregnant, and we anticipate that they will primarily be of female sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify 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, 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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous; Pre-Eclampsia; Premature Birth; Stillbirth

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sunitha Suresh

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunitha Suresh

CONTACT

(847) 570-2860; SSuresh@northshore.org

Kate Honeyfield

CONTACT

847-570-2243; KHoneyfield@northshore.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Placental pathologist will be masked to the outcome when assessing for maternal vascular malperfusion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, FPA

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 22, 2023
• Study Start: December 26, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)