Sublingual Microcirculation Change During Pregnancy and Postpartum Period

• Conditions: Microcirculation in Pregnancy

• Registration Number: NCT03476096
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2018-01-30
• Status Verified: 2018-02
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-03-18
• Last Update Submitted: 2018-03-18
• Study First Posted: 2018-03-23
• Last Update Posted: 2018-03-23
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of perfused vessel density	From the day before delivery to three days after delivery	Changes of perfused vessel density before and after delivery

Secondary Outcome Measures

Name	Time	Method
Changes of microvascular flow index	From the day before delivery to three days after delivery	Changes of microvascular flow index before and after delivery
Changes of heterogeneity index before	From the day before delivery to three days after delivery	Changes of heterogeneity index before and after delivery

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan