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The Use of the CPR to Predict Adverse Outcomes in GDM Pregnancies (CPR GDM)

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ClinicalTrials.gov Identifier: NCT03072563
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief 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. 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.

Condition or disease
Gestational Diabetes

Study Type : Observational
Estimated Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of the Cerebro-placental Ratio to Predict Adverse Outcomes in Pregnancies Complicated by Gestational Diabetes
Estimated Study Start Date : March 7, 2017
Estimated Primary Completion Date : March 7, 2019
Estimated Study Completion Date : March 7, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women diagnosed with gestational diabetes.
Criteria

Inclusion Criteria:

  • All women over the age of 18 years old with singleton pregnancies and a diagnosis of GDM at 24 weeks of gestation and beyond.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072563


Contacts
Contact: Karizma Mawjee 416-360-4000 ext 8084 mawjeek@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Howard Berger, MD    416-864-6060 ext 8408    BergerH@smh.toronto.on.ca   
Contact: Leanne R De Souza, PhD    416-864-6060 ext 8047    DeSouzaL@smh.toronto.on.ca   
Principal Investigator: Howard Berger, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03072563     History of Changes
Other Study ID Numbers: 16-382
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases