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

NCT ID: NCT05488197

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-07-10

Brief 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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1 participants with gestational diabetes

uterine artery doppler at 18-23 weeks of pregnancy

Intervention Type: OTHER

uterine artery doppler at 18-23 weeks of pregnancy

Group 2 participants without gestational diabetes

uterine artery doppler at 18-23 weeks of pregnancy

Intervention Type: OTHER

uterine artery doppler at 18-23 weeks of pregnancy

Interventions

uterine artery doppler at 18-23 weeks of pregnancy

uterine artery doppler at 18-23 weeks of pregnancy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Haseki Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Filiz Yarsilikal Guleroglu

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haseki Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PS-GDM-2022

Identifier Type: OTHER

Identifier Source: secondary_id

PS-GDM-2022

Identifier Type: -

Identifier Source: org_study_id