PS-GDM-2022: The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population

Sponsor
Haseki Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05488197
Collaborator
(none)
700
1
13
53.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: uterine artery doppler at 18-23 weeks of pregnancy

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 Design

Study Type:
Observational
Actual Enrollment :
700 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population
Actual Study Start Date :
Jun 10, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jul 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Group 1 participants with gestational diabetes

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:

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

Exclusion Criteria:
  • Pregestational Diabetes

  • Preeclampsia

  • Intrauterine growth restriction

  • Chronic Maternal Disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haseki Training and Research Hospital İstanbul Turkey

Sponsors and Collaborators

  • Haseki Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Filiz Yarsilikal Guleroglu, Medical Doctor, Haseki Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05488197
Other Study ID Numbers:
  • PS-GDM-2022
  • PS-GDM-2022
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022