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Completed

NCT Number: NCT05488197

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

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

uterine artery doppler at 18-23 weeks of pregnancy

Other

uterine artery doppler at 18-23 weeks of pregnancy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prediction of GDM with uterine artery pulsatility index cut-offs

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

    Cut off values of uterine artery pulsatility index will be estimated to predict GDM

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Acronym: PS-GDM-2022

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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