- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Taipei, Taiwan, 100
- Rekrytering
- National Taiwan University Hospital
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Kontakt:
- YiShiuan Lin, MD
- Telefonnummer: +886-2-2312-3456
- E-post: yslin918@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Control
healthy pregnant women
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Pre-eclampsia
high-risk pregnant women
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes of perfused vessel density
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes of microvascular flow index
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 201711067RINC
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