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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+)
Sponsor: Peking University Third Hospital
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-04-30
Completion Date
2025-12-31
Last Updated
2024-04-16
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone
This clinical study will plan to enrol 24 Chinese pregnant subjects with 34+0-35+6GW preterm preterm labour requiring dexamethasone treatment and 24 pregnant women with 34+0-38+6GW preterm preterm labour and a diagnosis of gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy, each of them randomly divided into 2 groups requiring 4 doses of dexamethasone intramuscularly (half-dose of 2.5 mg, normal dose of 5 mg) for two days as well as two active blood acquisitions. During the recruitment and screening phase, the purpose of the trial, the study protocol, and the trial procedure were described in detail so that the subjects were fully informed and participated voluntarily, and the compliance of the subjects in the conduct of the trial was improved.