PregnancyPhase 4NCT02376192
Maternal Microcirculation & SDF Imaging
A Phase 4 study testing Initial MicroScan® (Microvision Medical) SDF Measurement, Spinal Anesthesia- Bupivacaine and Comparative MicroScan® (Microvision Medical) SDF Measurement in people with Pregnancy, run by IWK Health Centre at 1 site in Canada.
Trial summary
This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Initial MicroScan® (Microvision Medical) SDF Measurement, Spinal Anesthesia- Bupivacaine and Comparative MicroScan® (Microvision Medical) SDF Measurement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 4
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)
- Singleton pregnancies
- 36-42 weeks gestation
- Non-labouring
- Scheduled cesarean delivery
- English speaking
- Age 18-45 years
Who cannot join
- Cardiovascular disease
- Hypertensive disease of pregnancy (i.e. mild \& severe preeclampsia)
- Allergy to phenylephrine, or any other standardized medication
- Obesity (BMI > 35 kg/m2)
- Diabetes Mellitus type 1
- Smoker
- Coffee/Caffeine intake within 6 hours of SDF measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension.
This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels.
- Conditions
- Pregnancy
- Being tested
- Initial MicroScan® (Microvision Medical) SDF Measurement, Spinal Anesthesia- Bupivacaine, Comparative MicroScan® (Microvision Medical) SDF Measurement, Bolus Phenylephrine/Ephedrine Treatment, Phenylephrine Infusion
- Keywords
- Microcirculation, Sidestream Dark Field (SDF) Imaging, Spinal Anesthesia, Phenylephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial MicroScan® (Microvision Medical) SDF MeasurementDevice
Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.
Spinal Anesthesia- BupivacaineDrug
The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.
Comparative MicroScan® (Microvision Medical) SDF MeasurementDevice
A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.
Bolus Phenylephrine/Ephedrine TreatmentDrug
Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.
Phenylephrine InfusionDrug
Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Bolus Phenylephrine/Ephedrine Treatment' | Experimental | Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants who experience hypotension will receive bolus phenylephrine and/or ephedrine treatment as needed. Receives: Device: Initial MicroScan® (Microvision Medical) SDF Measurement; Drug: Spinal Anesthesia- Bupivacaine; Device: Comparative MicroScan® (Microvision Medical) SDF Measurement; Drug: Bolus Phenylephrine/Ephedrine Treatment |
| Phenylephrine Infusion Group | Experimental | Initial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension. Receives: Device: Initial MicroScan® (Microvision Medical) SDF Measurement; Drug: Spinal Anesthesia- Bupivacaine; Device: Comparative MicroScan® (Microvision Medical) SDF Measurement; Drug: Phenylephrine Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular Flow Index (MFI)
The change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia
Measured: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Secondary outcomes (1)
Microvascular Flow Index (MFI)
The difference between the MFI measured within 10 minutes following the induction of spinal anesthesia in participants who receive phenylephrine via a continuous infusion for the prevention of spinal anesthesia-induced hypotension compared to those who may receive phenylephrine boluses for treatment of spinal anesthesia-induced hypotension.
Measured: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald George, IWK Health Centre
- Investigators
- Ronald B George, MD FRCPC, Principal investigator, IWK Health Centre, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376192
- Sponsor's protocol ID
- IWK1010276
- Status last verified
- Feb 2015
- First submitted
- 3 Sep 2014
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
George RB, DesRoches J, Abdo I, Lehmann C. Maternal microcirculation and sidestream dark field imaging: a prospective assessment of the association between labour pain and analgesia on the microcirculation of pregnant women. Clin Hemorheol Microcirc. 2015;60(4):389-95. doi: 10.3233/CH-141851.
PubMed 24934438Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014;63(4):395-408. doi: 10.33549/physiolres.932511. Epub 2014 Apr 3.
PubMed 24702490George RB, Munro A, Abdo I, McKeen DM, Lehmann C. An observational assessment of the sublingual microcirculation of pregnant and non-pregnant women. Int J Obstet Anesth. 2014 Feb;23(1):23-8. doi: 10.1016/j.ijoa.2013.08.013. Epub 2013 Sep 8.
PubMed 24342223Lehmann Ch, Abdo I, Kern H, Maddison L, Pavlovic D, Sharawi N, Starkopf J, Hall R, Johnson P, Williams L, Cerny V; MiDAS (Microcirculation Diagnostics and Applied Studies) group. Clinical evaluation of the intestinal microcirculation using sidestream dark field imaging--recommendations of a round table meeting. Clin Hemorheol Microcirc. 2014;57(2):137-46. doi: 10.3233/CH-141810.
PubMed 24448730
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension.
- ClinicalTrials.gov ID
- NCT02376192
- Acronym / sponsor ID
- IWK1010276
- Conditions
- Pregnancy
- Keywords
- Microcirculation, Sidestream Dark Field (SDF) Imaging, Spinal Anesthesia, Phenylephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
This is a study of pregnant women undergoing a cesarean delivery. It will compare their microcirculation before and after the anesthetic. Microcirculation means blood flow to the extremely small blood vessels in the body. It will also look at the differences in microcirculation of participants who receive an infusion of phenylephrine compared to participants who don't. The investigators hypothesize that spinal anesthesia will reduce the vascular density and proportion of perfused vessels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus Phenylephrine/Ephedrine Treatment' | Experimental | Device: Initial MicroScan® (Microvision Medical) SDF Measurement, Drug: Spinal Anesthesia- Bupivacaine, Device: Comparative MicroScan® (Microvision Medical) SDF Measurement, Drug: Bolus Phenylephrine/Ephedrine TreatmentInitial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants who experience hypotension will receive bolus phenylephrine and/or ephedrine treatment as needed. |
| Phenylephrine Infusion Group | Experimental | Device: Initial MicroScan® (Microvision Medical) SDF Measurement, Drug: Spinal Anesthesia- Bupivacaine, Device: Comparative MicroScan® (Microvision Medical) SDF Measurement, Drug: Phenylephrine InfusionInitial MicroScan® (Microvision Medical) SDF measurement are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. In the operating room participants will receive a standard spinal anesthetic (hyperbaric bupivacaine, fentanyl and preservative free morphine) followed by a second comparative MicroScan® (Microvision Medical) SDF measurement within 10 minutes of initiation of spinal anesthetic. Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy, ASA II - mild and controlled systemic disease)
- Singleton pregnancies
- 36-42 weeks gestation
- Non-labouring
- Scheduled cesarean delivery
Key exclusion criteria (7 listed)
- Cardiovascular disease
- Hypertensive disease of pregnancy (i.e. mild \& severe preeclampsia)
- Allergy to phenylephrine, or any other standardized medication
- Obesity (BMI > 35 kg/m2)
- Diabetes Mellitus type 1
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 |
|---|---|---|
| Initial MicroScan® (Microvision Medical) SDF MeasurementInitial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia. | Device | Bolus Phenylephrine/Ephedrine Treatment', Phenylephrine Infusion Group |
| Spinal Anesthesia- BupivacaineThe spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine. | Drug | Bolus Phenylephrine/Ephedrine Treatment', Phenylephrine Infusion Group |
| Comparative MicroScan® (Microvision Medical) SDF MeasurementA second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia. | Device | Bolus Phenylephrine/Ephedrine Treatment', Phenylephrine Infusion Group |
| Bolus Phenylephrine/Ephedrine TreatmentParticipants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed. | Drug | Bolus Phenylephrine/Ephedrine Treatment' |
| Phenylephrine InfusionParticipants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension. | Drug | Phenylephrine Infusion Group |
Primary outcome
Microvascular Flow Index (MFI)
Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
The change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia
1 secondary outcome
Microvascular Flow Index (MFI)
Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Background: PubMed 24934438George RB, DesRoches J, Abdo I, Lehmann C. Maternal microcirculation and sidestream dark field imaging: a prospective assessment of the association between labour pain and analgesia on the microcirculation of pregnant women. Clin Hemorheol Microcirc. 2015;60(4):389-95. doi: 10.3233/CH-141851.
- Background: PubMed 24702490Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014;63(4):395-408. doi: 10.33549/physiolres.932511. Epub 2014 Apr 3.
- Background: PubMed 24342223George RB, Munro A, Abdo I, McKeen DM, Lehmann C. An observational assessment of the sublingual microcirculation of pregnant and non-pregnant women. Int J Obstet Anesth. 2014 Feb;23(1):23-8. doi: 10.1016/j.ijoa.2013.08.013. Epub 2013 Sep 8.
- Background: PubMed 24448730Lehmann Ch, Abdo I, Kern H, Maddison L, Pavlovic D, Sharawi N, Starkopf J, Hall R, Johnson P, Williams L, Cerny V; MiDAS (Microcirculation Diagnostics and Applied Studies) group. Clinical evaluation of the intestinal microcirculation using sidestream dark field imaging--recommendations of a round table meeting. Clin Hemorheol Microcirc. 2014;57(2):137-46. doi: 10.3233/CH-141810.
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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.
Ronald B George, MD FRCPC principal investigator
IWK Health Centre, Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Initial MicroScan® (Microvision Medical) SDF Measurement, Spinal Anesthesia- Bupivacaine and Comparative MicroScan® (Microvision Medical) SDF Measurement in people with Pregnancy, run by IWK Health Centre at 1 site in Canada.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 3 Mar 2015. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microvascular Flow Index (MFI) (time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376192, which also lists 4 linked publications.
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 3 Mar 2015.