Using Placental Pathology to Prevent Recurrent Adverse Pregnancy Outcomes: A Pilot Project
ConditionAdverse Pregnancy Outcome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEndeavor Health
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lovenox 40mg
DrugEnoxaparin 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Enoxaparin GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite Adverse Pregnancy outcome
Preeclampsia with severe features, small for gestational age infant, preterm delivery \<37 weeks, neonatal death, and maternal death
Time frame
Enrollment through 6 weeks postpartumSecondary outcomes
1
Maternal vascular malperfusion (MVM)
Presence/ absence of MVM on placental pathology
Time frame
Placenta collected at time of delivery2
Preeclampsia with severe features
Defined by clinician
Time frame
Enrollment through 6 weeks postpartum3
Small for gestational age infant
By Fenton criteria
Time frame
At time of delivery4
Preterm delivery < 37 weeks
Time frame
Assessed at time of deliverySponsors and contacts
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Source ClinicalTrials.gov