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

Gestational Diabetes Clinical Trial

— PS-GDM-2022  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488197
• Other study ID #: PS-GDM-2022
• Secondary ID: PS-GDM-2022
• Status: Completed
• Start date: June 10, 2021
• Est. completion date: July 10, 2022

Study information

• Verified date: August 2022
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 10, 2022
• Est. primary completion date: June 30, 2022
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregestational Diabetes

• Preeclampsia

• Intrauterine growth restriction

• Chronic Maternal Disease

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• uterine artery doppler at 18-23 weeks of pregnancy
uterine artery doppler at 18-23 weeks of pregnancy

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 18 months
Secondary	Prediction of GDM with uterine artery pulsatility index cut-offs	Cut off values of uterine artery pulsatility index will be estimated to predict GDM	Through study completion, an average of 18 months