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+)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two studies will be conducted both of which are single-centre, open clinical studies. It is proposed to collect maternal blood, umbilical vein blood and placental tissue from pregnant women treated with dexamethasone, which excludes early placental detachment, use of surfactant, severe intrauterine haemorrhage, or pregnant women who meet the conditions of the exclusion criteria. Determination and implementation of dexamethasone treatment regimen will be carried out by clinicians in accordance with the treatment guidelines, and the collection of samples will be carried out in the form of opportunistic blood sampling or placenta collection after normal diagnostic and therapeutic operations of pregnant women except for 2 active collections of blood after dosing; this study will not interfere with the normal maternal pregnancy, labour and diagnostic and therapeutic processes. Half-dose study: A total of 24 Chinese pregnant subjects with 34+0-35+6 GW requiring dexamethasone treatment for preterm labour with preterm prematurity in China were planned to be enrolled in this study. A total of 12 subjects receiving 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the full-dose group; 12 subjects receiving 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the half-dose group. EXPLORATORY STUDY: This study was planned to enrol 24 pregnant women with 34+0-38+6 GW preterm labour with confirmed gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy in a dose exploratory study in this population. A total of 12 subjects were enrolled in the full-dose group to receive 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) and 12 subjects were enrolled in the half-dose group to receive 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses).

Conditions

• Respiratory Distress Syndrome of Newborn

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-04-30
• Completion: 2025-12-31
• First posted: 2024-04-05
• Last updated: 2024-04-16