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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Subjects with a prior adverse outcome in a prior pregnancy. Adverse outcome is defined as prior singleton preterm birth ( \< 37 weeks), SGA infant (defined as birthweight \< 10th percentile), preeclampsia with severe features, or stillbirth (fetal demise after 20 weeks gestation), as certified by an obstetrician

• Patients with maternal vascular malperfusion on pathology from pregnancy with prior adverse pregnancy outcome, as certified by a perinatal placental pathologist

• Current singleton pregnancy at \<16 6/7 weeks gestational age.

Locations
United States
Illinois
NorthShore University HealthSystem
RECRUITING
Evanston
Contact Information
Primary
Sunitha Suresh
SSuresh@northshore.org
(847) 570-2860
Backup
Kate Honeyfield
KHoneyfield@northshore.org
847-570-2243
Time Frame
Start Date: 2023-12-26
Estimated Completion Date: 2026-03
Participants
Target number of participants: 20
Treatments
Experimental: Enoxaparin Group
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.
No_intervention: Control Group
Participants in this group will have standard care as usual, with no additional medications.
Sponsors
Leads: Endeavor Health

This content was sourced from clinicaltrials.gov