Clinical trial NCT05488197: The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population
Official title: The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with or without Gestational Dibetes in low- risk population

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.

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

Primary outcomes:
measure: Uterine artery Doppler ultrasonography in gestational diabetes mellitus
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
measure: Prediction of GDM with uterine artery pulsatility index cut-offs
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
References: