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Anticoagulant

Lovenox for Pregnancy Outcomes

Phase 2
Recruiting
Led By Sunitha Suresh
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current singleton pregnancy at <16 6/7 weeks gestational age.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through 6 weeks postpartum
Awards & highlights

Summary

This trial aims to use placental pathology from a prior pregnancy to guide treatment in the next, reducing risk of recurrent adverse pregnancy events.

Who is the study for?
This trial is for individuals who had a prior pregnancy with complications like early delivery, very small babies, severe high blood pressure, or stillbirth. They must have had issues with the mother's blood vessels in the placenta and be currently pregnant with one baby before reaching 16 weeks and 6 days.
What is being tested?
The study tests if Lovenox (enoxaparin) can prevent bad outcomes in new pregnancies for those who previously faced such issues due to problems with blood flow in the placenta. Participants are randomly chosen to receive this treatment or not.
What are the potential side effects?
Lovenox may cause bleeding, bruising at injection sites, allergic reactions, and rarely more serious effects like blood clots or decreased platelets which help stop bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant with one baby and less than 17 weeks along.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite Adverse Pregnancy outcome
Secondary study objectives
Maternal vascular malperfusion (MVM)
Preeclampsia with severe features
Small for gestational age infant

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enoxaparin GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
Participants in this group will have standard care as usual, with no additional medications.

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,622 Total Patients Enrolled
Sunitha SureshPrincipal InvestigatorNorthShore University HealthSystem
1 Previous Clinical Trials
320 Total Patients Enrolled
~11 spots leftby Aug 2025