Pre-EclampsiaNCT03196141
Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
A study testing StO2 and EndoPAT in people with Pre-Eclampsia, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- StO2 and EndoPAT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Oct 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-pregnant group:
- > 18 years of age
- Male or female
- Pregnant group:
- > 18 years of age
- Pregnant women > 20 weeks
- Diagnosis of Pre-eclampsia characterized as Systolic BP > 140 mmHg, diastolic BP > 90 mmHg after 20 weeks of gestation accompanied by new onset of proteinuria.
- Normotensive, not meeting criteria in #3
Who cannot join
- Non-pregnant group:
- Raynaud's Disease
- Adhesive tape allergy
- Recent Myocardial Infarction (< 3 months)
- Congestive Heart Failure
- Pregnant group:
Show all 12Show fewer
- Raynaud's Disease
- Adhesive tape allergy
- Recent Myocardial Infarction (< 3 months)
- Congestive Heart Failure
- Hemodynamically unstable (SBP < 90 mmHg)
- Fetal distress
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.
Read the detailed description
In both normotensive women and others with pregnancy induced hypertension, in previous research simultaneous tissue oxygen saturation (StO2) were measured in both forearms, with a blood pressure cuff above the tissue oximetry probe on one side.
StO2 values were continuously monitored on each side during unilateral blood pressure (BP) cuff inflation (to suprasystolic pressure for 3 min), and then during deflation. Despite similarity in the forearm StO2 decline observed with cuff inflation in all women, the rise following cuff deflation - indicative of reactive hyperemia - appeared reduced in hypertensive patients, suggesting a relationship with impaired endothelial reserve.
- Conditions
- Pre-Eclampsia
- Being tested
- StO2 and EndoPAT
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StO2 and EndoPATDiagnostic test
- StO2 probe is a lightweight plastic probe that will be applied over the brachioradilalis muscle (anterolatereal aspect of the forearm) where there is less subcutaneous fat and taped in place.
- The EndoPAT probe will be place on a finger on the same arm.
- Pulse oximeter probes will be connected to a finger on each hand.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Part#1: 15 healthy volunteers; 2 assessment sessions. Session 1: StO2 vs. EndoPAT Method comparison analysis; both StO2 and EndoPAT will be applied simultaneously \& pulse oximeter probes placed bilaterally on fingers. Baseline readings will be taken for 5 minutes. The blood pressure cuff will be inflated to suprasystolic pressure and StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.
Session 2: This session will occur within 1 week of session 1. This session is to determine the consistency of the response.
All probes will be applied as in session 1 and cycles of 10 minutes for 3 sessions will be done. All the measurements in session 1 will be captured in session 2.
This will determine inter-day variability. (total time is 53 min). Receives: Diagnostic Test: StO2 and EndoPAT |
| Pregnant women with normal BP | Active comparator | Part #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor.
Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.
Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV).
Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study.
All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness. Receives: Diagnostic Test: StO2 and EndoPAT |
| Pregnant women with high BP | Active comparator | Part #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor.
Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions.
Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV).
Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study.
All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness.
Participants with hypertension will be followed in conjunction with routine clinical follow-up at 2, 6 and 12 weeks post-partum. Receives: Diagnostic Test: StO2 and EndoPAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
StO2
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
Measured: Baseline
StO2
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
Measured: 48 Hours (Postpartum)
Endopat
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
Measured: Baseline
Endopat
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
Measured: 48 Hours (Postpartum)
SphygmoCor
SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.
Measured: Baseline
SphygmoCor
SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.
Measured: 48 Hours (Postpartum)
Secondary outcomes (3)
StO2
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in hypertensive pregnant participants.
Measured: 2, 6, 12 weeks (Postpartum)
Endopat
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in hypertensive pregnant participants.
Measured: 2, 6, 12 weeks (Postpartum)
SphygmoCor
SphygmoCor is a measurement of vascular stiffness. This will only be measured in hypertensive pregnant participants.
Measured: 2, 6, 12 weeks (Postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Why it stopped: not able to recruit enough participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aymen Alilan, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196141
- Sponsor's protocol ID
- 2000020110
- Status last verified
- Jul 2019
- First submitted
- 20 Jun 2017
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Clinical Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women
- ClinicalTrials.gov ID
- NCT03196141
- Acronym / sponsor ID
- 2000020110
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not able to recruit enough participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 22 Jun 2017 (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.
The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.
Detailed description
In both normotensive women and others with pregnancy induced hypertension, in previous research simultaneous tissue oxygen saturation (StO2) were measured in both forearms, with a blood pressure cuff above the tissue oximetry probe on one side.
StO2 values were continuously monitored on each side during unilateral blood pressure (BP) cuff inflation (to suprasystolic pressure for 3 min), and then during deflation. Despite similarity in the forearm StO2 decline observed with cuff inflation in all women, the rise following cuff deflation - indicative of reactive hyperemia - appeared reduced in hypertensive patients, suggesting a relationship with impaired endothelial reserve.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups: healthy volunteers (15) and normotensive (10) and pre-eclamptic (10) pregnant women during their visit to labor floor.
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Diagnostic Test: StO2 and EndoPATPart#1: 15 healthy volunteers; 2 assessment sessions. Session 1: StO2 vs. EndoPAT Method comparison analysis; both StO2 and EndoPAT will be applied simultaneously \& pulse oximeter probes placed bilaterally on fingers. Baseline readings will be taken for 5 minutes. The blood pressure cuff will be inflated to suprasystolic pressure and StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions. Session 2: This session will occur within 1 week of session 1. This session is to determine the consistency of the response. All probes will be applied as in session 1 and cycles of 10 minutes for 3 sessions will be done. All the measurements in session 1 will be captured in session 2. This will determine inter-day variability. (total time is 53 min). |
| Pregnant women with normal BP | Active comparator | Diagnostic Test: StO2 and EndoPATPart #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor. Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions. Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV). Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study. All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness. |
| Pregnant women with high BP | Active comparator | Diagnostic Test: StO2 and EndoPATPart #2: 20 participants, 10 normotensive and 10 pre-eclamptic pregnant women during their visit to labor floor. Session 1: Both StO2 and EndoPAT will be applied simultaneously to the same arm below a BP cuff. Baseline readings will be taken for 5 minutes, the blood pressure cuff will be inflated to suprasystolic pressure StO2 and pulsatile volume changes will be measured by peripheral arterial tonometry, continuous measurement for 3 min and repeated every 10 minutes for 3 sessions. Additionally, vascular stiffness with be measured by SphygmoCor to measure pulse wave velocity (PWV). Participants must also agree to participate OB/GYN biobanking protocol HIC# 1601017004 to be in this study. All participants will have follow-up at 48 hours, including a blood draw, assessment of endothelial function and vascular stiffness. Participants with hypertension will be followed in conjunction with routine clinical follow-up at 2, 6 and 12 weeks post-partum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 18 years of age
- Male or female
- > 18 years of age
- Pregnant women > 20 weeks
- Diagnosis of Pre-eclampsia characterized as Systolic BP > 140 mmHg, diastolic BP > 90 mmHg after 20 weeks of gestation accompanied by new onset of proteinuria.
Key exclusion criteria (12 listed)
- Raynaud's Disease
- Adhesive tape allergy
- Recent Myocardial Infarction (< 3 months)
- Congestive Heart Failure
- Raynaud's Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StO2 and EndoPAT* StO2 probe is a lightweight plastic probe that will be applied over the brachioradilalis muscle (anterolatereal aspect of the forearm) where there is less subcutaneous fat and taped in place. * The EndoPAT probe will be place on a finger on the same arm. * Pulse oximeter probes will be connected to a finger on each hand. | Diagnostic test | Healthy volunteers, Pregnant women with high BP, Pregnant women with normal BP |
Primary outcome
StO2
Time frame: Baseline
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
StO2
Time frame: 48 Hours (Postpartum)
Measurement of forearm StO2 during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
Endopat
Time frame: Baseline
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. Baseline measures are collected in healthy and pregnant participants.
Endopat
Time frame: 48 Hours (Postpartum)
Measurement of Endopat during routine cycling of a blood pressure cuff can provide a continuous index of endothelial functional reserve. This will only be measured in pregnant participants.
SphygmoCor
Time frame: Baseline
SphygmoCor is a measurement of vascular stiffness. This will only be measured in pregnant participants.
SphygmoCor
Time frame: 48 Hours (Postpartum)
SphygmoCor is a measurement of vascular stiffness. Baseline measures are collected in healthy and pregnant participants.
3 secondary outcomes
StO2
Time frame: 2, 6, 12 weeks (Postpartum)
Endopat
Time frame: 2, 6, 12 weeks (Postpartum)
SphygmoCor
Time frame: 2, 6, 12 weeks (Postpartum)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Aymen Alilan principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StO2 and EndoPAT in people with Pre-Eclampsia, run by Yale University at 1 site in United States.
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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 12 Jul 2019. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
StO2 (time frame: Baseline). The study lists 6 primary outcomes in all. 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 12 Jul 2019.