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DISPATCH: Decreasing Intervention Using sFlt-1/PlGF Applied to Chronic Hypertension (DISPATCH)

9. November 2026 aktualisiert von: University of California, San Francisco

Decreasing Intervention Using sFlt-1/PlGF Applied to Chronic Hypertension (DISPATCH Trial): A Pilot, Open-label, Randomized Controlled Trial

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

74

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94158
        • University of California, San Francisco

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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 prior to 20 weeks 0 days in the current pregnancy. Use during a prior pregnancy and through 12 weeks postpartum, or use for stage 1 chronic hypertension are not exclusions.

  • Evaluated in triage for worsening chronic hypertension, rule out preeclampsia due to:

    • Worsening blood pressures from baseline and/or development of severe range blood pressures
    • Preeclampsia associated symptoms: headache, vision changes, abdominal pain
    • New onset proteinuria or worsening proteinuria
    • Lab abnormalities suspicious for preeclampsia including anemia, signs of hemolysis, thrombocytopenia, increasing serum creatinine, elevated liver function tests
    • Any other concerning features of preeclampsia according to the evaluating clinician

Exclusion Criteria:

  • Hemolysis, elevated liver enzymes, low platelet syndrome (HELLP syndrome), pulmonary edema, eclamptic seizure, stroke, myocardial infarction, placental abruption, or heart failure.
  • Absent or reversed end-diastolic flow in the umbilical artery Doppler
  • Unable to consent
  • Major birth defect or chromosomal abnormality that may necessitate preterm birth for other reasons
  • Other pregnancy complication that may necessitate preterm birth (e.g., PPROM)
  • IV Heparin use within 24 hours of the lab draw
  • Exogenous PlGF-2 or PlGF-3 given for therapeutic use at a concentration higher than 100 pg/mL

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Conceal arm

The clinical team will be blinded to assay results and will manage as per their usual clinical protocol.
Diagnosetest: sFlt/PlGF without 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.

Conceal arm: The clinical team will be blinded to assay results and will manage chronic hypertension as per their usual clinical protocol.
Experimental: Reveal arm

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.
Diagnosetest: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment rate
Zeitfenster: At month 6

Number of participants enrolled per week
At month 6
Protocol adherence in the reveal arm
Zeitfenster: At month 6

What proportion of participants in the reveal arm adhered to the clinical algorithm of management based on the assay result.
At month 6

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time until delivery using a time-to-event analysis
Zeitfenster: From date of randomization until the date of delivery

Assessing weeks from the initial enrollment in the trial to delivery
From date of randomization until the date of delivery
Delivery with superimposed preeclampsia with severe features.
Zeitfenster: At the date of delivery

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.
At the date of delivery
Rate of preterm birth at <35 weeks
Zeitfenster: At month 6
At month 6
Rate of preterm birth at <37 weeks
Zeitfenster: At month 6
At month 6
Maternal admission rate
Zeitfenster: At month 6

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
At month 6
Maternal admission days
Zeitfenster: Date of randomization to 6 weeks postpartum

Defined 1) randomization to delivery and 2) in the postpartum period up to 6 weeks
Date of randomization to 6 weeks postpartum
Maternal admission to the ICU
Zeitfenster: Date of randomization to 6 weeks postpartum

1) in pregnancy or 2) within 6 weeks postpartum
Date of randomization to 6 weeks postpartum
Severe maternal morbidity (with and without transfusion)
Zeitfenster: Date of randomization to 6 weeks postpartum

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
Date of randomization to 6 weeks postpartum
Gestational age at delivery
Zeitfenster: Date of delivery
Date of delivery
Birthweight
Zeitfenster: Date of delivery
Date of delivery
Birthweight percentile
Zeitfenster: Date of delivery
Date of delivery
Mode of delivery
Zeitfenster: Date of delivery
Date of delivery
Neonatal admission to the NICU
Zeitfenster: Date of delivery
Date of delivery
Days of neonatal admission to the NICU
Zeitfenster: Date of delivery to 6 weeks postpartum
Date of delivery to 6 weeks postpartum
Neonatal composite morbidity
Zeitfenster: Date of delivery to 6 weeks postpartum
  • 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
Date of delivery to 6 weeks postpartum

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Ermittler

  • Hauptermittler: Juan M Gonzalez Velez, MD PhD, University of California, San Francisco

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

4. November 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. November 2026

Zuerst gepostet (Tatsächlich)

13. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00000922

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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