An observational study in Diabetes, sponsored by Eastern Virginia Medical School. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Eastern Virginia Medical School · Observational
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.
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 156 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
We plan to recruit 52 individuals with diabetes and 104 control subjects from the reference population of the human placenta project (IRB #15-09-FB-0179).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Criteria for inclusion of subjects * Patients who enter pregnancy with a diagnosis of type I or type II diabetes mellitus. * Pregnant women between the ages of 18-45 * Live, singleton gestation * Understanding and ability to give informed consent Criteria for exclusion of subjects * Patient unwilling or unable to provide consent * Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians) * Age less than 18 years of age * Multifetal gestation * Chromosomal abnormality * Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19 * Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)
The control group will be a referent population of the Human Placenta Project. This reference population consists of patients who meet the following criteria: Maternal: * Pregnancy Conceived Without Assisted Reproduction * Singleton gestation * Delivery: \>37 0/7 weeks gestation * No gestational diabetes * No fetal growth restriction * No Smoking/ Alcohol/Drugs History; * Placenta Implantation: Normal * Fetal Umbilical Cord abnormalities: None; Fetal- Newborn Outcomes: * Gestational Age at Delivery: \>37 0/7 * No Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19 * No Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc) * Fetal -Newborn Weight \>10 percentile ( no Hx of FGR or SGA)
Elevated TcB
The primary objective of this study is to identify if increased fetal liver volumes correlate with elevated transcutaneous bilirubin (TcB) in neonates of mothers with diabetes.
Time frame: June 2023 to June 2025
Respiratory Distress
One or more signs of increased work of breathing, such as tachypnea with a respiratory rate \> 60 breaths per minute, nasal flaring, chest retractions, or grunting \[13\] requiring oxygen support
Time frame: June 2023 to June 2025
Jaundice
Jaundice requiring phototherapy
Time frame: June 2023 to June 2025
Hypoglycemia
\<40 mg/dl in the first 24 hours of life
Time frame: June 2023 to June 2025
Polycythemia
Hematocrit \>65% or hemoglobin \>22 mg/dl
Time frame: June 2023 to June 2025
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jan 2025, 19 months after the start.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's planned 19 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
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Eastern Virginia Medical School