drugset / Trial / NCT06350565

A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)

NCT06350565 ↗

Unknown 48 enrolled Peking University Third Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.

Timeline

Start
2024-04-30
Primary completion
2025-04-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 2.5 mg Intramuscular
Subject Dexamethasone Small molecule 5 mg Intramuscular