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Anticoagulant

Lovenox for Pregnancy Outcomes

Q: Is it feasible for me to join this research project?

In order to be eligible for this trial, expecting mothers must meet the following prerequisites: between 18 and 60 years of age; having experienced a prior undesired <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a> outcome such as premature birth, small-for-gestational age infant, preeclampsia with severe features or stillbirth after 20 weeks gestation; vascular malperfusion on pathology from previous pregnancy; currently pregnant at 16 6/7 weeks gestational age. A total of twenty patients are being admitted.

Q: Is there an age restriction on participation in this research project?

This medical study is accessible to <a href="https://www.withpower.com/clinical-trials/all">all</a> candidates who are of legal age and under 60 years old.

Q: What is the scope of participation in this medical experiment?

Affirmative. The clinical trial is presently recruiting, as indicated by the information posted on clinicaltrials.gov. This medical research was initially published on December 1st 2023 and has since been updated on November 28th 2023. As part of this study, they are attempting to enrol a total of 20 patients across one site.

Q: Are there any vacancies available for enrollees in this clinical experiment?

Correct. According to the information archived on clinicaltrials.gov, this study is actively enrolling patients and has been updated since its initial posting of December 1st 2023. Specifically, it seeks out 20 individuals from a single location.

Q: What danger can Enoxaparin Group pose to recipients?

The safety of enoxaparin is rated a 2, as there is evidence to support its security, but none affirming the medication's efficacy.

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Adverse Pregnancy outcome

Secondary outcome measures

Maternal Death

Maternal vascular malperfusion (MVM)

Neonatal Death

+3 more

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

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,642 Total Patients Enrolled

Sunitha SureshPrincipal InvestigatorNorthShore University HealthSystem

1 Previous Clinical Trials

320 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to join this research project?

"In order to be eligible for this trial, expecting mothers must meet the following prerequisites: between 18 and 60 years of age; having experienced a prior undesired pregnancy outcome such as premature birth, small-for-gestational age infant, preeclampsia with severe features or stillbirth after 20 weeks gestation; vascular malperfusion on pathology from previous pregnancy; currently pregnant at 16 6/7 weeks gestational age. A total of twenty patients are being admitted."

Answered by AI

Is there an age restriction on participation in this research project?

"This medical study is accessible to all candidates who are of legal age and under 60 years old."

Answered by AI

What is the scope of participation in this medical experiment?

"Affirmative. The clinical trial is presently recruiting, as indicated by the information posted on clinicaltrials.gov. This medical research was initially published on December 1st 2023 and has since been updated on November 28th 2023. As part of this study, they are attempting to enrol a total of 20 patients across one site."

Answered by AI

Are there any vacancies available for enrollees in this clinical experiment?

"Correct. According to the information archived on clinicaltrials.gov, this study is actively enrolling patients and has been updated since its initial posting of December 1st 2023. Specifically, it seeks out 20 individuals from a single location."

Answered by AI