DISPATCH: Decreasing Intervention Using sFlt-1/PlGF Applied to Chronic Hypertension (DISPATCH)
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ophelia Yin, MD
- Telefonní číslo: (415) 894-9416
- E-mail: ophelia.yin@ucsf.edu
Studijní záloha kontaktů
- Jméno: Alison Wenz
- Telefonní číslo: 415-502-3344
- E-mail: Alison.Wenz@ucsf.edu
Studijní místa
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California
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San Francisco, California, Spojené státy, 94158
- University of California, San Francisco
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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Age 18 and older
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Singleton living pregnancy
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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
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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.
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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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Conceal arm
The clinical team will be blinded to assay results and will manage as per their usual clinical protocol. |
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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Experimentální: 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. |
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).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Recruitment rate
Časové okno: At month 6
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Number of participants enrolled per week |
At month 6
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Protocol adherence in the reveal arm
Časové okno: At month 6
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What proportion of participants in the reveal arm adhered to the clinical algorithm of management based on the assay result. |
At month 6
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time until delivery using a time-to-event analysis
Časové okno: From date of randomization until the date of delivery
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Assessing weeks from the initial enrollment in the trial to delivery |
From date of randomization until the date of delivery
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Delivery with superimposed preeclampsia with severe features.
Časové okno: At the date of delivery
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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
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Rate of preterm birth at <35 weeks
Časové okno: At month 6
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At month 6
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Rate of preterm birth at <37 weeks
Časové okno: At month 6
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At month 6
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Maternal admission rate
Časové okno: At month 6
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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
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Maternal admission days
Časové okno: Date of randomization to 6 weeks postpartum
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Defined 1) randomization to delivery and 2) in the postpartum period up to 6 weeks |
Date of randomization to 6 weeks postpartum
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Maternal admission to the ICU
Časové okno: Date of randomization to 6 weeks postpartum
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1) in pregnancy or 2) within 6 weeks postpartum |
Date of randomization to 6 weeks postpartum
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Severe maternal morbidity (with and without transfusion)
Časové okno: Date of randomization to 6 weeks postpartum
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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
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Gestational age at delivery
Časové okno: Date of delivery
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Date of delivery
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Birthweight
Časové okno: Date of delivery
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Date of delivery
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Birthweight percentile
Časové okno: Date of delivery
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Date of delivery
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Mode of delivery
Časové okno: Date of delivery
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Date of delivery
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Neonatal admission to the NICU
Časové okno: Date of delivery
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Date of delivery
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Days of neonatal admission to the NICU
Časové okno: Date of delivery to 6 weeks postpartum
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Date of delivery to 6 weeks postpartum
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Neonatal composite morbidity
Časové okno: Date of delivery to 6 weeks postpartum
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Date of delivery to 6 weeks postpartum
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Juan M Gonzalez Velez, MD PhD, University of California, San Francisco
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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