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

Completed

• Conditions: Gestational Diabetes
• Interventions: Other: uterine artery doppler at 18-23 weeks of pregnancy

• Registration Number: NCT05488197
• Lead Sponsor: Haseki Training and Research Hospital

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.

Study Timeline

• Study Start: 2021-06-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-10
• Study First Submitted: 2022-07-28
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 participants with gestational diabetes	uterine artery doppler at 18-23 weeks of pregnancy	-
Group 2 participants without gestational diabetes	uterine artery doppler at 18-23 weeks of pregnancy	-

Primary Outcome Measures

Name	Time	Method
Uterine artery Doppler ultrasonography in gestational diabetes mellitus	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 Outcome Measures

Name	Time	Method
Prediction of GDM with uterine artery pulsatility index cut-offs	Through study completion, an average of 18 months	Cut off values of uterine artery pulsatility index will be estimated to predict GDM

Trial Locations

Locations (1)

Haseki Training and Research Hospital; 🇹🇷 İstanbul, Turkey