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- Klinische proef NCT03476096
Sublingual Microcirculation Change During Pregnancy and Postpartum Period (Cytocam-OBS)
Sublingual Microcirculation Change in Pregnant Women With or Without High Risk Pregnancy Factors During Pregnancy and Postpartum Period
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Microcirculation system is composed of a group of blood vessels less than 100 um in diameter composed of arterioles, capillaries, veins and other structures. The health of microcirculation system correlates well with the stability of systemic circulation. Perfusio of microcirculation is often affected by major diseases such as sepsis, shock and heart disease. Through various microcirculation monitoring instruments, the investigators can assess the disease severity and prognosis.
Physiological changes during pregnancy will increase the blood volume, stroke volume, and microcirculation. Preeclampsia refers to the development of hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) after 20 weeks of gestation with proteinuria. Severe preeclampsia is associated with impaired endothelial cell circulation throughout the body, and reduced sublingual microcirculation perfusion.
Through the sublingual microcirculation monitor, studies have shown that pregnant women have more microcirculation perfusion than non-pregnant women, while women with severe preeclampsia and those with HELLP syndrome have impaired microcirculation.
This study aims to investigate whether there is any change in the sublingual microcirculation before and after labor in healthy pregnant women and high-risk pregnant women (such as epilepsy, gestational diabetes, etc.) through the third generation of microcirculation imaging microscope (cytocam).
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital
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Contact:
- YiShiuan Lin, MD
- Telefoonnummer: +886-2-2312-3456
- E-mail: yslin918@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Healthy pregnant women older than 20 years old who will delivery baby in our hospital (both normal spontaneous delivery and cesarean section).
- Women over 20 years of age who will delivery baby in our hospital (both normal spontaneous delivery and cesarean section) and meet the definition of high-risk pregnancy such as gestational diabetes mellitus, placenta previa, placenta accreta, gestational hypertension, preeclampsia or severe preeclampsia.
Exclusion Criteria:
- Chronic hypertension or diabetes
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Control
healthy pregnant women
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Pre-eclampsia
high-risk pregnant women
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes of perfused vessel density
Tijdsspanne: From the day before delivery to three days after delivery
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Changes of perfused vessel density before and after delivery
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From the day before delivery to three days after delivery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes of microvascular flow index
Tijdsspanne: From the day before delivery to three days after delivery
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Changes of microvascular flow index before and after delivery
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From the day before delivery to three days after delivery
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Changes of heterogeneity index before
Tijdsspanne: From the day before delivery to three days after delivery
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Changes of heterogeneity index before and after delivery
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From the day before delivery to three days after delivery
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 201711067RINC
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