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.
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Ophelia Yin, MD
- Telefonszám: (415) 894-9416
- E-mail: ophelia.yin@ucsf.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Alison Wenz
- Telefonszám: 415-502-3344
- E-mail: Alison.Wenz@ucsf.edu
Tanulmányi helyek
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California
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San Francisco, California, Egyesült Államok, 94158
- University of California, San Francisco
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Diagnosztikai
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Placebo Comparator: 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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Kísérleti: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Recruitment rate
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Time until delivery using a time-to-event analysis
Időkeret: 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.
Időkeret: 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
Időkeret: At month 6
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At month 6
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Rate of preterm birth at <37 weeks
Időkeret: At month 6
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At month 6
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Maternal admission rate
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: Date of delivery
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Date of delivery
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Birthweight
Időkeret: Date of delivery
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Date of delivery
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Birthweight percentile
Időkeret: Date of delivery
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Date of delivery
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Mode of delivery
Időkeret: Date of delivery
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Date of delivery
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Neonatal admission to the NICU
Időkeret: Date of delivery
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Date of delivery
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Days of neonatal admission to the NICU
Időkeret: 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
Időkeret: Date of delivery to 6 weeks postpartum
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Date of delivery to 6 weeks postpartum
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Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Juan M Gonzalez Velez, MD PhD, University of California, San Francisco
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- STUDY00000922
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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