Microcirculation in PregnancyCytocam-OBSNCT03476096
Sublingual Microcirculation Change During Pregnancy and Postpartum Period
An observational study of Microcirculation in Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Sublingual microcirculation change in pregnant women with or without high risk pregnancy factors during pregnancy and postpartum period. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Microcirculation in Pregnancy
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jan 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: healthy pregnant women and high-risk pregnant women (gestational diabetes mellitus, placenta previa, placenta accreta, gestational hypertension, preeclampsia or severe preeclampsia.)
Who may be able to join
- 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.
Who cannot join
- Chronic hypertension or diabetes
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
YiShiuan Lin, MD, +886-2-2312-3456, yslin918@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Microcirculation in Pregnancy
- Keywords
- pregnancy, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | healthy pregnant women | |
| Pre-eclampsia | high-risk pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of perfused vessel density
Changes of perfused vessel density before and after delivery
Measured: From the day before delivery to three days after delivery
Secondary outcomes (2)
Changes of microvascular flow index
Changes of microvascular flow index before and after delivery
Measured: From the day before delivery to three days after delivery
Changes of heterogeneity index before
Changes of heterogeneity index before and after delivery
Measured: From the day before delivery to three days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start30 Jan 2018
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculation in PregnancyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476096
- Sponsor's protocol ID
- 201711067RINC
- Acronym
- Cytocam-OBS
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Microcirculation Change in Pregnant Women With or Without High Risk Pregnancy Factors During Pregnancy and Postpartum Period
- ClinicalTrials.gov ID
- NCT03476096
- Acronym / sponsor ID
- Cytocam-OBS / 201711067RINC
- Conditions
- Microcirculation in Pregnancy
- Keywords
- pregnancy, microcirculation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –healthy pregnant women |
| Pre-eclampsia | – | –high-risk pregnant women |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- healthy pregnant women and high-risk pregnant women (gestational diabetes mellitus, placenta previa, placenta accreta, gestational hypertension, preeclampsia or severe preeclampsia.)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Chronic hypertension or diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Changes of microvascular flow index
Time frame: From the day before delivery to three days after delivery
Changes of heterogeneity index before
Time frame: From the day before delivery to three days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculation in Pregnancy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YiShiuan Lin (+886-2-23123456, yslin918@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of perfused vessel density (time frame: From the day before delivery to three days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.