Status:
COMPLETED
Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial
Lead Sponsor:
Medical University of Warsaw
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor for multiple mate...
Detailed Description
This is a randomized controlled trial performed at the 1st Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will recruit 100 women at 24-28 weeks of gestation . Women...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- singleton pregnancy between 24-28 weeks of gestation
- gestational diabetes mellitus diagnosis
Exclusion
- multiple pregnancy
- fetal malformations
- pre-gestational diabetes mellitus
- chronic or pregnancy-induced hypertension
- chronic renal or hepatic disease, in-vitro fertilization
- delivery \<37 weeks of gestation
- pre-mature rupture of membranes
- placenta previa
- stillbirth
- smoking in pregnancy
- intake of medications including: methyldopa, tetracyclin, acetylosalicylic acid, acetaminofen, ibuprofen, L-dopa, tolazamide, tolbutamide
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04422821
Start Date
September 1 2020
End Date
November 10 2022
Last Update
December 22 2022
Active Locations (1)
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1
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
Warsaw, Starynkiewicza Sq. 1/3, Poland, 02-015