DiabetesNCT06407388
Ultrasound Findings in Diabetic Pregnancies
An observational study of Diabetes, run by Eastern Virginia Medical School at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Jun 2025
- 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
- No healthy volunteers
- Adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School
Norfolk, Virginia, 23507
Alyssa Savelli, MD, 757-446-7900, kawakit@evms.edu
Kristin Ayers, MPH, 7574460579, ayerskl@evms.edu
About this study
Official title: Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies
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.
Read the 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | 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) | |
| Controls | 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2023 to June 2025
Secondary outcomes (4)
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
Measured: June 2023 to June 2025
Jaundice
Jaundice requiring phototherapy
Measured: June 2023 to June 2025
Hypoglycemia
<40 mg/dl in the first 24 hours of life
Measured: June 2023 to June 2025
Polycythemia
Hematocrit >65% or hemoglobin >22 mg/dl
Measured: June 2023 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyssa Savelli-Binsted, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407388
- Sponsor's protocol ID
- 23-03-FB-0061
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies
- ClinicalTrials.gov ID
- NCT06407388
- Acronym / sponsor ID
- 23-03-FB-0061
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 9 May 2024 (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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –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) |
| Controls | – | –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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
Elevated TcB
Time frame: June 2023 to June 2025
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.
4 secondary outcomes
Respiratory Distress
Time frame: June 2023 to June 2025
Jaundice
Time frame: June 2023 to June 2025
Hypoglycemia
Time frame: June 2023 to June 2025
Polycythemia
Time frame: June 2023 to June 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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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 Diabetes, run by Eastern Virginia Medical School at 1 site in United States.
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 4 inclusion and 7 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 9 May 2024. 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 United States. 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 Kristin Ayers, MPH (7574460579, ayerskl@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elevated TcB (time frame: June 2023 to June 2025). 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 9 May 2024.