RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: a Pilot Project (UPPPP Trial)

Quick Facts

Study Start:2023-12-26
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06004674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Anticoagulation planned for current pregnancy (including warfarin, enoxaparin, heparin)
  2. 2. Known major fetal anomaly
  3. 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. 4. Chronic kidney disease with eGFR\< 60
  5. 5. Known chronic liver disease with baseline AST/ALT \> 3 x upper limit of normal
  6. 6. Subjects with mechanical prosthetic heart valves

Contacts and Locations

Study Contact

Sunitha Suresh
CONTACT
(847) 570-2860
SSuresh@northshore.org
Kate Honeyfield
CONTACT
847-570-2243
KHoneyfield@northshore.org

Principal Investigator

Sunitha Suresh
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University HealthSystem
Evanston, Illinois, 60201
United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

  • Sunitha Suresh, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-26
Study Completion Date2025-08

Study Record Updates

Study Start Date2023-12-26
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Adverse Pregnancy Outcome