Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350565
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-13
Brief Title:
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
Organization:
Peking University Third Hospital
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study plans to conduct a DEX dose halving study and a normal dose study in 340-356 GW women with preterm preterm labour In addition this study plans to conduct a DEX dose halving study and a normal dose study in 34-386 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 340-356 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 25 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 340-386 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 25 mg dexamethasone intramuscular injection q12h 4 doses
Half-dose study A total of 24 Chinese pregnant subjects with 340-356 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 25 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 340-386 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 25 mg dexamethasone intramuscular injection q12h 4 doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None