An interventional study of sFlt/PlGF lab assay with change in clinical care and sFlt/PlGF without change in clinical care in Preeclampsia, Chronic Hypertension Complicating Pregnancy and Pregnancy, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Diagnostic
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Among 229 studies in Pre-Eclampsia with a site in United States — 61 open to participants now, 77 under way, 6 of them phase 3. Pre-Eclampsia · United States.
Among the 229 studies in Pre-Eclampsia with a site in United States, this one is the 85th largest by planned enrollment of the 160 interventional ones that give a count, is one of 3 that started in 2027, is one of 72 with no phase, reaches primary completion later than 41 of the 76 other live ones, and was the 229th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →61 of the 229 studies in Pre-Eclampsia with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 18–50 · Women only
University of California, Irvine · Sites in United States
Ages 18+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 16–56 · Women only
Texas Southern University · Sites in United States
Ages 18–45 · Women only
Medicines360 · Sites in United States
Ages 18–99 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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229 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 24 · Phase 3 15 · Phase 4 31
First in 2000; this study’s year is marked. 3 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 74 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Median enrollment 88 across the 160 interventional studies, 125 across the 69 observational. Of the 126 that completed or were terminated, 54 (43%) have results posted.
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13 of 229 have an industry lead sponsor. The 10 most frequent:
University of California, San Francisco is the lead sponsor of 2,171 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
University of California, San Francisco has 1 study filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
27 of the studies in Pre-Eclampsia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07222852Phase 3Women and Infants Hospital of Rhode IslandCardiovascular Protection After Preeclampsia With Enalapril | 2027-10-15 |
| NCT07293728Oregon Health and Science UniversityA Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia | 2026-12 |
| NCT07356518Wake Forest University Health SciencesTelehealth and Remote Blood Pressure | 2026-12 |
| NCT05676476University of Alabama at BirminghamThe ACHIEVE Trial: Achieving Longer Gestation in Preeclampsia Via Antihypertensive Therapy. | 2026-12 |
| NCT05924971MemorialCare Health SystemAspirin for Postpartum Patients With Preeclampsia | 2026-12 |
Add all 27 to your calendar (.ics) → With an account.
Among the 229 studies in Pre-Eclampsia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 and ratio) and result status (normal \<40 or abnormal using the cut-off ≥40) and will be encouraged to discharge patients with a normal result. The ultimate decision to admit or discharge will still be based on the decision making of the clinical team; 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). Repeat PlGF and sFlt-1 concentration and ratio testing will occur for participants who re-present to triage ≥7 days from the prior test, and on a weekly basis for participants who are admitted. For participants in the reveal group who have had an abnormal result, additional concentration and ratio testing will be performed but results will not be reported to the clinical team.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Chronic hypertension, defined as:
Evaluated in triage for worsening chronic hypertension, rule out preeclampsia due to:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The clinical team will be blinded to assay results and will manage as per their usual clinical protocol.
Diagnostic Test: sFlt/PlGF without change in clinical care
The clinical team will receive qualitative assay results normal (sFlt-1/PlGF \<40) or abnormal (sFlt-1/PlGF ³40)) and the ratio value and concentrations of PlGF and sFlt-1.
Diagnostic Test: sFlt/PlGF lab assay with change in clinical care
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.
Recruitment rate
Number of participants enrolled per week
Time frame: At month 6
Protocol adherence in the reveal arm
What proportion of participants in the reveal arm adhered to the clinical algorithm of management based on the assay result.
Time frame: At month 6
Time until delivery using a time-to-event analysis
Assessing weeks from the initial enrollment in the trial to delivery
Time frame: From date of randomization until the date of delivery
Delivery with superimposed preeclampsia with severe features.
The endpoint will be analyzed for different follow-up times including \<35 weeks of gestation. Analysis will take into account the potentially diverging directions of the effect in the patient strata of ratio results (levels: "abnormal", "normal"; cut-off 40; assuming reduction of deliveries in the "normal" stratum and increase in the "abnormal" stratum due to improved risk stratification by the ratio), e.g. by using (a) regression modelling with interaction term study arm x ratio result, or (b) stratification of the analysis by ratio result.
Time frame: At the date of delivery
Rate of preterm birth at <35 weeks
Time frame: At month 6
Rate of preterm birth at <37 weeks
Time frame: At month 6
Maternal admission rate
1\) defined as the number of participants admitted at least once in the antepartum period divided by the total number of participants in that arm of the trial and 2) defined as the number of participants admitted at least once in the postpartum period divided by the total number of participants in that arm of the trial
Time frame: At month 6
Maternal admission days
Defined 1) randomization to delivery and 2) in the postpartum period up to 6 weeks
Time frame: Date of randomization to 6 weeks postpartum
Maternal admission to the ICU
1\) in pregnancy or 2) within 6 weeks postpartum
Time frame: Date of randomization to 6 weeks postpartum
Severe maternal morbidity (with and without transfusion)
Severe maternal morbidity (without transfusion) is defined as the occurrence of at least one of the following during pregnancy, delivery, or in the first 6 weeks postpartum: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest or conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, hemorrhagic or embolic stroke, pulmonary edema, severe anesthesia complication, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism, hysterectomy, temporary tracheostomy, mechanical ventilation
Time frame: Date of randomization to 6 weeks postpartum
Gestational age at delivery
Time frame: Date of delivery
Birthweight
Time frame: Date of delivery
Birthweight percentile
Time frame: Date of delivery
Mode of delivery
Time frame: Date of delivery
Neonatal admission to the NICU
Time frame: Date of delivery
Days of neonatal admission to the NICU
Time frame: Date of delivery to 6 weeks postpartum
Neonatal composite morbidity
* Neonatal major morbidity as measured in pregnancy and up to 6 weeks postpartum is defined as the occurrence of at least one of the following: death (fetal or neonatal death through 28 days postpartum), hypoxic ischemic encephalopathy, intraventricular hemorrhage, cardiopulmonary resuscitation, necrotizing enterocolitis, persistent pulmonary hypertension, bronchopulmonary dysplasia, mechanical ventilation, seizure, sepsis, birth trauma (fracture, brachial plexus injury, facial palsy) * Neonatal minor morbidity as measured in pregnancy and up to 6 weeks postpartum is defined as the occurrence of at least one of the following: respiratory distress syndrome, hypoglycemia, meconium aspiration syndrome, and neonatal jaundice requiring phototherapy
Time frame: Date of delivery to 6 weeks postpartum
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jul 2027, 6 months later.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 6 months is below that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco →