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+)

NANot yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

April 30, 2025

Study Completion Date

December 31, 2025

Conditions
Respiratory Distress Syndrome of Newborn
Interventions
DRUG

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.

All Listed Sponsors
lead

Peking University Third Hospital

OTHER

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+) | Biotech Hunter | Biotech Hunter