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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ophelia Yin, MD
- 電話番号：(415) 894-9416
- メール：ophelia.yin@ucsf.edu
研究連絡先のバックアップ
- 名前：Alison Wenz
- 電話番号：415-502-3344
- メール：Alison.Wenz@ucsf.edu
研究場所
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California
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San Francisco、California、アメリカ、94158
- University of California, San Francisco
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time until delivery using a time-to-event analysis
時間枠：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.
時間枠：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
時間枠：At month 6
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At month 6
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Rate of preterm birth at <37 weeks
時間枠：At month 6
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At month 6
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Maternal admission rate
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：Date of delivery
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Date of delivery
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Birthweight
時間枠：Date of delivery
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Date of delivery
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Birthweight percentile
時間枠：Date of delivery
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Date of delivery
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Mode of delivery
時間枠：Date of delivery
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Date of delivery
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Neonatal admission to the NICU
時間枠：Date of delivery
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Date of delivery
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Days of neonatal admission to the NICU
時間枠：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
時間枠：Date of delivery to 6 weeks postpartum
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Date of delivery to 6 weeks postpartum
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協力者と研究者
捜査官
- 主任研究者：Juan M Gonzalez Velez, MD PhD、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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