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

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

Study Overview

• Status: Unknown
• Conditions: 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).

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: YiShiuan Lin, MD; Phone Number: +886-2-2312-3456; Email: yslin918@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of perfused vessel density	Changes of perfused vessel density before and after delivery	From the day before delivery to three days after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of microvascular flow index	Changes of microvascular flow index before and after delivery	From the day before delivery to three days after delivery
Changes of heterogeneity index before	Changes of heterogeneity index before and after delivery	From the day before delivery to three days after delivery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 18, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pregnancy; microcirculation
• Other Study ID Numbers: 201711067RINC