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CompletedNCT05488197PS-GDM-2022Updated Aug 4, 2022

The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population

An observational study in Gestational Diabetes, sponsored by Haseki Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Haseki Training and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
700
Ages
18 Years to 42 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Gestational Diabetes

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In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 700 is above the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

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Lead sponsor

Haseki Training and Research Hospital is the lead sponsor of 75 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Pregnant women with or without Gestational Dibetes in low- risk population

Inclusion criteria

  • Pregnant women with or without Gestational Diabetes in low- risk population

Exclusion criteria

Exclusion Criteria:

  • Pregestational Diabetes
  • Preeclampsia
  • Intrauterine growth restriction
  • Chronic Maternal Disease
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
700 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Otheruterine artery doppler at 18-23 weeks of pregnancy

    uterine artery doppler at 18-23 weeks of pregnancy

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Through study completion, an average of 18 months

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Study locations

1 site
  • Haseki Training and Research Hospital
    İstanbul, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05488197
Lead sponsor
Haseki Training and Research Hospital
Responsible party
Filiz Yarsilikal Guleroglu (Medical Doctor, Haseki Training and Research Hospital) — Principal investigator
First posted
Aug 4, 2022
Start date
Jun 10, 2021
Primary completion
Jun 30, 2022
Completion
Jul 10, 2022
Last update
Aug 4, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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