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NCT03072563: CPR GDM
The Use of the CPR to Predict Adverse Outcomes in GDM Pregnancies
trial in Gestational Diabetes in 207 participants. Status unknown.
7 March 2021
Quick facts
| Lead sponsor | Unity Health Toronto |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 207 |
| Start date | 7 March 2017 |
| Primary completion | 7 March 2021 |
| Estimated completion | 7 March 2021 |
| Sites | 1 location across Canada |
Conditions studied
- Gestational Diabetes — all drugs for Gestational Diabetes →
Sponsor
Unity Health Toronto — full company profile →
Who can join
Adults 18 to 45, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03072563
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03072563 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Unity Health Toronto
- Last refreshed: 29 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03072563.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing