Gestational DiabetesPS-GDM-2022NCT05488197
The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population
An observational study of Gestational Diabetes, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In the current literature, there are not enough studies related to the use of uterine artery Doppler indices in the second trimester for the prediction of GDM. Considering that it may be useful in the prediction of GDM in low-risk patient groups for GDM, it was found useful to consider uterine artery Doppler analysis… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- uterine artery doppler at 18-23 weeks of pregnancy
- How many people
- 700 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2021to 10 Jul 2022
- 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 42 years
- Women only
- Adult
Study population: Pregnant women with or without Gestational Dibetes in low- risk population
Who may be able to join
- Pregnant women with or without Gestational Diabetes in low- risk population
Who cannot join
- Pregestational Diabetes
- Preeclampsia
- Intrauterine growth restriction
- Chronic Maternal Disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul
About this study
In the current literature, there are not enough studies related to the use of uterine artery Doppler indices in the second trimester for the prediction of GDM. Considering that it may be useful in the prediction of GDM in low-risk patient groups for GDM, it was found useful to consider uterine artery Doppler analysis within the scope of this study.In this study, the investigators aimed to assess the value of second-trimester uterine artery Doppler analysis in the prediction of GDM in a low- risk population.
Read the detailed description
This retrospective research was conducted between June 2020 and December 2021 at the Perinatology Clinic of Haseki Training and Research Hospital. Maternal age between 18 and 42 years and gestational age between 18 and 23 weeks were the inclusion criteria.Pregnant women's computerized records were used to compare the relevant data of women diagnosed with gestational diabetes and women with normal glucose tolerance . Transabdominal ultrasonography was performed for anatomical scanning, and the uterine artery Doppler was obtained using ultrasonographic devices with a 2.0-7.0 megahertz convex probe. The uterine artery waveforms were obtained using pulsed-wave Doppler with an insonation angle of 30° and a peak systolic velocity greater than 60 cm/s. Three identical waveforms were obtained consecutively on each side. In addition to recording the presence or absence of notching, the mean uterine artery pulsatility index (UAPI) was also obtained. Abnormal uterine artery Doppler was defined as a mean UAPI greater than the 95th percentile for each gestation.Increased uterine artery pulsatility index and/or diastolic notch in the uterine artery between 18-23 weeks of pregnancy can predict the risk of GDM in pregnant women.
- Conditions
- Gestational Diabetes
- Being tested
- uterine artery doppler at 18-23 weeks of pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery doppler at 18-23 weeks of pregnancyOther
uterine artery doppler at 18-23 weeks of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 participants with gestational diabetes | Not described Receives: Other: uterine artery doppler at 18-23 weeks of pregnancy | |
| Group 2 participants without gestational diabetes | Not described Receives: Other: uterine artery doppler at 18-23 weeks of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine artery Doppler ultrasonography in gestational diabetes mellitus
To investigate and compare uterine artery pulsatility index by Doppler ultrasonography in patients with gestational diabetes mellitus (GDM) and without to non-diabetic controls.
Measured: Through study completion, an average of 18 months
Secondary outcomes (1)
Prediction of GDM with uterine artery pulsatility index cut-offs
Cut off values of uterine artery pulsatility index will be estimated to predict GDM
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start10 Jun 2021
- Primary completion30 Jun 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Yarsilikal Guleroglu, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488197
- Sponsor's protocol ID
- PS-GDM-2022
- Other IDs
- PS-GDM-2022
- Acronym
- PS-GDM-2022
- Status last verified
- Aug 2022
- First submitted
- 28 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population
- ClinicalTrials.gov ID
- NCT05488197
- Acronym / sponsor ID
- PS-GDM-2022 / PS-GDM-2022
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 4 Aug 2022 (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.
In the current literature, there are not enough studies related to the use of uterine artery Doppler indices in the second trimester for the prediction of GDM. Considering that it may be useful in the prediction of GDM in low-risk patient groups for GDM, it was found useful to consider uterine artery Doppler analysis within the scope of this study.In this study, the investigators aimed to assess the value of second-trimester uterine artery Doppler analysis in the prediction of GDM in a low- risk population.
Detailed description
This retrospective research was conducted between June 2020 and December 2021 at the Perinatology Clinic of Haseki Training and Research Hospital. Maternal age between 18 and 42 years and gestational age between 18 and 23 weeks were the inclusion criteria.Pregnant women's computerized records were used to compare the relevant data of women diagnosed with gestational diabetes and women with normal glucose tolerance . Transabdominal ultrasonography was performed for anatomical scanning, and the uterine artery Doppler was obtained using ultrasonographic devices with a 2.0-7.0 megahertz convex probe. The uterine artery waveforms were obtained using pulsed-wave Doppler with an insonation angle of 30° and a peak systolic velocity greater than 60 cm/s. Three identical waveforms were obtained consecutively on each side. In addition to recording the presence or absence of notching, the mean uterine artery pulsatility index (UAPI) was also obtained. Abnormal uterine artery Doppler was defined as a mean UAPI greater than the 95th percentile for each gestation.Increased uterine artery pulsatility index and/or diastolic notch in the uterine artery between 18-23 weeks of pregnancy can predict the risk of GDM in pregnant women.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 participants with gestational diabetes | – | Other: uterine artery doppler at 18-23 weeks of pregnancy |
| Group 2 participants without gestational diabetes | – | Other: uterine artery doppler at 18-23 weeks of pregnancy |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women with or without Gestational Dibetes in low- risk population
Key inclusion criteria (1 listed)
- Pregnant women with or without Gestational Diabetes in low- risk population
Key exclusion criteria (4 listed)
- Pregestational Diabetes
- Preeclampsia
- Intrauterine growth restriction
- Chronic Maternal Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterine artery doppler at 18-23 weeks of pregnancyuterine artery doppler at 18-23 weeks of pregnancy | Other | Group 1 participants with gestational diabetes, Group 2 participants without gestational diabetes |
Primary outcome
Uterine artery Doppler ultrasonography in gestational diabetes mellitus
Time frame: Through study completion, an average of 18 months
To investigate and compare uterine artery pulsatility index by Doppler ultrasonography in patients with gestational diabetes mellitus (GDM) and without to non-diabetic controls.
1 secondary outcome
Prediction of GDM with uterine artery pulsatility index cut-offs
Time frame: Through study completion, an average of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gestational Diabetes, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine artery Doppler ultrasonography in gestational diabetes mellitus (time frame: Through study completion, an average of 18 months). 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 4 Aug 2022.