Adverse Pregnancy OutcomePhase 2NCT06004674
Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
A Phase 2 study testing Lovenox 40mg in people with Adverse Pregnancy Outcome, run by Endeavor Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adverse Pregnancy Outcome
- What is being tested?
- Lovenox 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2023to Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Anticoagulation planned for current pregnancy (including warfarin, enoxaparin, heparin)
- Known major fetal anomaly
- 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
- Chronic kidney disease with eGFR< 60
- Known chronic liver disease with baseline AST/ALT > 3 x upper limit of normal
- Subjects with mechanical prosthetic heart valves
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NorthShore University HealthSystem
Evanston, Illinois, 60201
Sunitha Suresh, MD
About this study
Official title: Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project (UPPPP Trial)
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.
Read the detailed description
In this clinical trial, participants will undergo consent, blood samples will be collected, and participants will be randomized in a 1:1 ratio to the enoxaparin or control groups at their first study visit.
- Participants will return for a study visit within 1 week following randomization.
- If assigned to the enoxaparin, the participant will be asked to take a dose of the enoxaparin once a day (40 mg daily) daily from 12 0/7 weeks and/or the start of enrollment (whichever is later) and continue until 36 weeks gestational age, after which enoxaparin will be discontinued.
- Participants in the control group will have care as usual, with no additional medications.
- During this study, a study team member will collect a blood sample from all participants at 20-24 weeks, 32-34 weeks, and at delivery.
- Participants in the enoxaparin group will have their blood work checked a week after starting medication to ensure that they have no unanticipated side effects.
Researchers will compare the enoxaparin group to the control group to see if enoxaparin prevents or reduces the occurrence or severity of maternal vascular malperfusion (MVM) among patients with a prior adverse pregnancy outcome.
- Conditions
- Adverse Pregnancy Outcome
- Being tested
- Lovenox 40mg
- Keywords
- miscarriage, preeclampsia, preterm delivery, stillbirth, Low birth weight
- Medical subject headings
- Abortion, Spontaneous, Pre-Eclampsia, Premature Birth, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovenox 40mgDrug
Also called Enoxaparin
Enoxaparin is a blood thinner. It is approved for use in the prevention of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness; inpatient treatment of acute DVT with or without pulmonary embolism; outpatient treatment of acute DVT without pulmonary embolism; Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction; treatment of acute ST-segment elevation myocardial infarction(STEMI) managed medically or with subsequent percutaneous coronary intervention. The use of Lovenox has been shown to be safe, and it has also been used widely off-label in pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin Group | Experimental | 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. Receives: Drug: Lovenox 40mg |
| Control Group | No intervention | Participants in this group will have standard care as usual, with no additional medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Adverse Pregnancy outcome
Preeclampsia with severe features, small for gestational age infant, preterm delivery <37 weeks, neonatal death, and maternal death
Measured: Enrollment through 6 weeks postpartum
Secondary outcomes (6)
Maternal vascular malperfusion (MVM)
Presence/ absence of MVM on placental pathology
Measured: Placenta collected at time of delivery
Preeclampsia with severe features
Defined by clinician
Measured: Enrollment through 6 weeks postpartum
Small for gestational age infant
By Fenton criteria
Measured: At time of delivery
Preterm delivery < 37 weeks
Measured: Assessed at time of delivery
Neonatal Death
Measured: Assessed from time of delivery to 6 weeks postpartum
Maternal Death
Measured: Assessed from enrollment to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start26 Dec 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Pregnancy OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunitha Suresh, Endeavor Health
- Investigators
- Sunitha Suresh, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004674
- Sponsor's protocol ID
- EH22-128
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No