Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407388
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Ultrasound Findings in Diabetic Pregnancies
Sponsor:
Eastern Virginia Medical School
Organization:
Eastern Virginia Medical School
Study Overview
Official Title:
Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes Specifically we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin TcB in the newborn and thus jaundice requiring phototherapy This information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes
Detailed Description:
This is a single center prospective case control study Cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project IRB 15-09-FB-0179 If patients agree to participate one ultrasound will be performed at 30-34 weeks gestation to look at the fetal parameters as described below It is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy Patients who are diagnosed with pregestational diabetes at EVMS routinely undergo an ultrasound at 30-34 weeks gestation Therefore ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed At the time of enrollment the PI or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation Code 76811 These patients will then be followed prospectively until delivery The neonates of the study patients will be followed via chart review after delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None