- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03783169
SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy (SASH)
6 januari 2020 uppdaterad av: TriHealth Inc.
• Adjunctive use of easily-obtainable maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance) in clinical decision-making potentially leading to more appropriate pharmacologic and clinical therapies with faster resolution of severe hypertension among pregnant women and women in the postpartum period.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
- Minutes count when it comes to treating and preventing serious complications associated with hypertensive emergencies in pregnancy. The rates of maternal morbidity and mortality are on the rise within the United States whereas the rates are falling in the rest of the developed world. Cardiovascular and neurologic injury associated with the severe hypertension witnessed among women with preeclampsia/eclampsia represent two of the leading causes of maternal mortality within the U.S. Optimizing the clinical identification and response to these perinatal complications represents one means of reducing overall maternal mortality.
- Point-of-care use of ultrasound technology to augment clinical diagnosis and management is gaining traction throughout nearly all fields of medicine. Obstetricians utilize this technology frequently to assess the fetus and maternal-fetal interface, and our ability to expand its use to assess a deeper understanding of maternal physiology is underutilized. Exploration into the ability to apply clinically-proven point-of-care sonographic techniques to augment maternal care and reduce maternal mortality is warranted.
- The purpose of this study is to gain a deeper understanding of maternal physiologic changes using easily-obtainable sonographic vascular measurements in the setting of hypertensive emergencies and to assess the utility of these adjunctive maternal sonographic measurements in augmenting clinical decision-making.
Studietyp
Observationell
Inskrivning (Förväntat)
120
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45220
- Rekrytering
- TriHealth - Good Samaritan and Bethesda North Hospitals
-
Kontakt:
- Ganga Devaiah, MS
- Telefonnummer: 513-862-2341
- E-post: ganga_devaiah@trihealth.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
- Group 1: All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure > 160 mmHg or sustained diastolic blood pressure > 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
- Group 2: All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
Beskrivning
Inclusion Criteria:
- For symptomatic women, those presenting to triage, admitted to Labor & Delivery or any of the above units who are at risk for developing a hypertensive emergency will be identified by the OBGYN resident staff or attending physicians as "at risk" for hypertensive emergency as based on current chronic hypertension, gestational hypertension, or preeclampsia). Women presenting with or developing new onset hypertensive emergency can be offered recruitment as well given that the performance of these sonographic measures will not interfere with initiating antihypertensive therapy.
Exclusion Criteria:
- Age < 18 years
- Non-pregnant
- Without the capacity to provide informed written consent
- Non-English speaking without the ability to obtain a hospital interpreter
- Known atrial-ventricular heart block
- History of heart failure
- Moderate-to-Severe bronchial asthma
- Allergy to the medications used as part of regular care treatment of the patient population
- Lack of intravenous IV access
- Concurrent use of antihypertensive medications
- Congenital heart disease in the mother
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Symptomatic patients
All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure > 160 mmHg or sustained diastolic blood pressure > 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart).
All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
|
Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)
|
Asymptomatic patients
All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost.
All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
|
Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Systolic Blood Pressure
Tidsram: At Enrollment into the Study
|
Systolic Blood Pressure at Enrollment into the Study
|
At Enrollment into the Study
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: William Schnettler, MD, TriHealth Inc.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 december 2018
Primärt slutförande (Förväntat)
1 december 2020
Avslutad studie (Förväntat)
1 december 2020
Studieregistreringsdatum
Först inskickad
19 december 2018
Först inskickad som uppfyllde QC-kriterierna
19 december 2018
Första postat (Faktisk)
20 december 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 18-027
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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