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

Phase 2

Recruiting

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Enoxaparin Group	Lovenox 40mg	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.

Primary Outcome Measures

Name	Time	Method
Composite Adverse Pregnancy outcome	Enrollment through 6 weeks postpartum	Preeclampsia with severe features, small for gestational age infant, preterm delivery \<37 weeks, neonatal death, and maternal death

Secondary Outcome Measures

Name	Time	Method
Preterm delivery < 37 weeks	Assessed at time of delivery
Maternal vascular malperfusion (MVM)	Placenta collected at time of delivery	Presence/ absence of MVM on placental pathology
Maternal Death	Assessed from enrollment to 6 weeks postpartum
Preeclampsia with severe features	Enrollment through 6 weeks postpartum	Defined by clinician
Small for gestational age infant	At time of delivery	By Fenton criteria
Neonatal Death	Assessed from time of delivery to 6 weeks postpartum

Locations (1): NorthShore University HealthSystem
🇺🇸
Evanston, Illinois, United States

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