University of California, San Francisco
This pilot study tests the feasibility of conducting an interventional study in pregnant people with chronic hypertension with interventional clinical management based on sFlt-1/PlGF. It will also collect data on time to delivery, the incidence of preterm delivery, and other maternal or neonatal complications, for a pivotal trial.
Participants with chronic hypertension between 23+0 and 34+6 weeks presenting to triage for rule out superimposed preeclampsia. They will be randomly assigned to two groups at a 1:1 ratio, conceal or reveal, and will be tested with the sFlt-1/PlGF assay. In the conceal group, participants will have their blood tested but the results will not be returned to the participants or their clinical providers, and thus the participants will continue to receive routine clinical care in pregnancy. In the reveal group, the clinical team will be notified of the assay results (PlGF and sFlt-1 concentrations…
Inclusion Criteria: * Age 18 and older * Singleton living pregnancy * Gestational age between 23+0 and 34+6 weeks gestation, confirmed by a fetal crown-rump length measurement in a first trimester ultrasound or by in vitro fertilization dates * Chronic hypertension, defined as: * At least 2 blood pressure measurements 140 systolic or 90 diastolic 4 hours apart diagnosed at less than 20 weeks 0 days of gestation and within 12 months of conception. * History or current use of anti-hypertensive medications for the indication of lowering blood pressure within 12 months prior to conception or…
Diagnostic testing with sFlt/PlGF assay at each obstetric emergency room or admission in which the participant is being evaluated for preeclampsia. Testing will occur at each evaluation or if the participant is admitted to the hospital, weekly. Reveal arm: the clinical team will receive qualitative assay results normal (sFlt-1/PlGF \<40) or abnormal (sFlt-1/PlGF \>=40). * If normal, the clinical team will be encouraged to manage the patient expectantly, with discharge home and routine outpatient surveillance or if the patient is admitted, to continue expectant management without delivery. If a patient with a normal result is admitted and/or delivered, the clinical team will be asked to record the reason(s) behind the decision(s). * If abnormal, the clinical team should consider superimposed preeclampsia and will manage per their usual clinical protocol. If a patient with an abnormal result is discharged, the clinical team will be asked to record the reason(s) behind the decision(s).
Diagnostic testing with sFlt/PlGF assay at each obstetric emergency room or admission in which the participant is being evaluated for preeclampsia. Testing will occur at each evaluation or if the participant is admitted to the hospital, weekly. Conceal arm: The clinical team will be blinded to assay results and will manage chronic hypertension as per their usual clinical protocol.
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