Gestational DiabetesCPR GDMNCT03072563
The Use of the CPR to Predict Adverse Outcomes in GDM Pregnancies
An observational study of Gestational Diabetes, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral artery pulsatility index (PI) to the umbilical artery PI. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 207 participants
- Where
- 1 siteCanada
- Study dates
- 7 Mar 2017to 7 Mar 2021
- 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 18 to 45 years
- Women only
- Adult
Study population: Pregnant women diagnosed with gestational diabetes.
Who may be able to join
- All women over the age of 18 years old with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond.
Who cannot join
- Pre-gestational diabetes, Hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW < 10% or suspected fetal anemia (and thus requiring a clinically indicated CPR measurement) poor grasp of english
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Howard Berger, MD, 416-864-6060 ext. 8408, BergerH@smh.toronto.on.ca
Leanne R De Souza, PhD, 416-864-6060 ext. 8047, DeSouzaL@smh.toronto.on.ca
About this study
Official title: The Use of the Cerebro-placental Ratio to Predict Adverse Outcomes in Pregnancies Complicated by Gestational Diabetes
The cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral artery pulsatility index (PI) to the umbilical artery PI. In Gestational Diabetes (GDM), the common finding is of accelerated and asymmetric fetal growth. Pregnancies complicated by GDM have an increased risk of certain complications such as preeclampsia, intrauterine demise, CS due to fetal distress. These complications have a well known association with fetal growth restriction leading to the hypothesis that there exists a subset of diabetic fetuses that exhibit a growth restriction phenotype despite not being small for gestational age (<10%).The objective of this study is to examine whether the CPR can identify GDM fetuses that are not growth restricted but are at increased risk of certain adverse neonatal outcomes. Women with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond will be included. Exclusion criteria are Pre-gestational diabetes, hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW < 10%(IUGR). Women who consent to the study will have a blinded Doppler assessment of CPR. Clinicians will be blinded to these Doppler measurements (unless they are indicated clinically for another reason (suspected fetal anemia or IUGR development- and the results will be unblinded and reported to the clinicians). Obstetric and neonatal outcomes will be collected prospctively via the local BORN database and the patient chart. Local BORN is needed for the registered outcomes. Newborns will be divided post-hoc into two groups: A) last CPR <10% B) Last CPR > 10%. The primary outcome will be a composite outcome consisting of one or more of the following: Caesarean section due to suspected fetal distress, 5 minute Apgar <7, Cord arterial PH < 7, HIE, NICU admission >24 hours.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
Caesarean section due to suspected fetal distress, 5 minute Apgar <7, Cord arterial PH < 7, HIE, NICU admission >24 hours
Measured: 24 weeks gestation to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start7 Mar 2017
- Primary completion7 Mar 2021 (estimated)
- Study completion7 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072563
- Sponsor's protocol ID
- 16-382
- Acronym
- CPR GDM
- Status last verified
- Apr 2020
- First submitted
- 2 Mar 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Cerebro-placental Ratio to Predict Adverse Outcomes in Pregnancies Complicated by Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03072563
- Acronym / sponsor ID
- CPR GDM / 16-382
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 7 Mar 2021 (estimated)
- Study completion
- 7 Mar 2021 (estimated)
- First posted
- 7 Mar 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 cerebro-placental ratio (CPR) is a tool for assessment of fetal wellbeing in the management of the growth restricted fetus. CPR is the ratio of the fetal middle cerebral artery pulsatility index (PI) to the umbilical artery PI. In Gestational Diabetes (GDM), the common finding is of accelerated and asymmetric fetal growth. Pregnancies complicated by GDM have an increased risk of certain complications such as preeclampsia, intrauterine demise, CS due to fetal distress. These complications have a well known association with fetal growth restriction leading to the hypothesis that there exists a subset of diabetic fetuses that exhibit a growth restriction phenotype despite not being small for gestational age (<10%).The objective of this study is to examine whether the CPR can identify GDM fetuses that are not growth restricted but are at increased risk of certain adverse neonatal outcomes. Women with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond will be included. Exclusion criteria are Pre-gestational diabetes, hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW < 10%(IUGR). Women who consent to the study will have a blinded Doppler assessment of CPR. Clinicians will be blinded to these Doppler measurements (unless they are indicated clinically for another reason (suspected fetal anemia or IUGR development- and the results will be unblinded and reported to the clinicians). Obstetric and neonatal outcomes will be collected prospctively via the local BORN database and the patient chart. Local BORN is needed for the registered outcomes. Newborns will be divided post-hoc into two groups: A) last CPR <10% B) Last CPR > 10%. The primary outcome will be a composite outcome consisting of one or more of the following: Caesarean section due to suspected fetal distress, 5 minute Apgar <7, Cord arterial PH < 7, HIE, NICU admission >24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with gestational diabetes.
Key inclusion criteria (1 listed)
- All women over the age of 18 years old with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond.
Key exclusion criteria (1 listed)
- Pre-gestational diabetes, Hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal EFW < 10% or suspected fetal anemia (and thus requiring a clinically indicated CPR measurement) poor grasp of english
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
Composite outcome
Time frame: 24 weeks gestation to delivery
Caesarean section due to suspected fetal distress, 5 minute Apgar <7, Cord arterial PH < 7, HIE, NICU admission >24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- 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.
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 Gestational Diabetes, run by Unity Health Toronto 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 1 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 29 Apr 2020. 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.
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 Karizma Mawjee (416-360-4000 ext. 8084, mawjeek@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: 24 weeks gestation to 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 29 Apr 2020.