TCTR20260710003Active, not recruitingNot Applicable
Comparison of the Effects of Epidural Analgesia during Labor on Maternal Blood Glucose, Cortisol Levels, and Neonatal Outcomes in Parturients With or Without Gestational Diabetes Mellitus
Not provided0 sites126 target enrollmentStarted: August 1, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 126
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to 40 Years (—)
- Sex
- Female
Inclusion Criteria
- •1.Pregnant women aged 18 to 40 years
- •2.Singleton pregnancy, cephalic presentation
- •3.Gestational age 37 to 42 weeks, planned for vaginal delivery
- •4.Cervical dilation 3 to 4 centimeters at the time of epidural catheter placement
- •5.American Society of Anesthesiologists (ASA) physical status I to II, with no major underlying medical illness
- •6.Willing and consenting to receive epidural labor analgesia
- •7.For the gestational diabetes group: diagnosed with gestational diabetes mellitus according to the Vietnam Ministry of Health guideline (Decision 1470/QD-BYT, 2024), based on the 75 gram, 2 hour oral glucose tolerance test, managed by diet and exercise only, without insulin treatment
- •8.For the comparison group: negative result on the above oral glucose tolerance test performed during the same period of pregnancy
Exclusion Criteria
- •1.Pre-existing type 1 or type 2 diabetes diagnosed before pregnancy
- •2.Gestational diabetes mellitus requiring insulin treatment
- •3.Endocrine disorders affecting cortisol or glucose metabolism, such as Cushing syndrome or adrenal insufficiency
- •4.Severe preeclampsia, eclampsia, complete placenta previa, prior uterine scar, or threatened uterine rupture
- •5.Fetal growth restriction, severe polyhydramnios, or severe oligohydramnios
- •6.Current use of systemic corticosteroids, or last dose taken less than 72 hours before the onset of labor
- •7.Contraindication to epidural analgesia, or refusal of the procedure by the patient
Investigators
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