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Sublingual Microcirculation Change During Pregnancy and Postpartum Period (Cytocam-OBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Sublingual microcirculation change in pregnant women with or without high risk pregnancy factors during pregnancy and postpartum period.

Condition or disease
Microcirculation in Pregnancy

Detailed Description:

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).

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Group/Cohort
Control
healthy pregnant women
Pre-eclampsia
high-risk pregnant women



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
healthy pregnant women and high-risk pregnant women (gestational diabetes mellitus, placenta previa, placenta accreta, gestational hypertension, preeclampsia or severe preeclampsia.)
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: YiShiuan Lin +886-2-23123456 yslin918@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: YiShiuan Lin, MD    +886-2-2312-3456    yslin918@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03476096    
Other Study ID Numbers: 201711067RINC
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: February 2018
Keywords provided by National Taiwan University Hospital:
pregnancy
microcirculation