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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of delivery

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met