Sublingual Microcirculation Change During Pregnancy and Postpartum Period (Cytocam-OBS)
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|ClinicalTrials.gov Identifier: NCT03476096|
Recruitment Status : Unknown
Verified February 2018 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
|Condition or disease|
|Microcirculation in Pregnancy|
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).
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Sublingual Microcirculation Change in Pregnant Women With or Without High Risk Pregnancy Factors During Pregnancy and Postpartum Period|
|Actual Study Start Date :||January 30, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
healthy pregnant women
high-risk pregnant women
- Changes of perfused vessel density [ Time Frame: From the day before delivery to three days after delivery ]Changes of perfused vessel density before and after delivery
- Changes of microvascular flow index [ Time Frame: From the day before delivery to three days after delivery ]Changes of microvascular flow index before and after delivery
- Changes of heterogeneity index before [ Time Frame: From the day before delivery to three days after delivery ]Changes of heterogeneity index before and after delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476096
|Contact: YiShiuan Linfirstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: YiShiuan Lin, MD +886-2-2312-3456 email@example.com|