NCT05207852

Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 288 (estimated)
• Sponsor: Dongyang Liu · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study through to the pregnant woman blood concentrations of dexamethasone therapy after research, explore the pharmacokinetic data of dexamethasone in pregnant women, Chinese pregnant women dexamethasone pharmacokinetic model, provide a reference for the clinical use of dexamethasone dose, through the biomarkers of dexamethasone to promote fetal lung maturity and other metabolomics, It provides the basis for the effectiveness and safety study of dexamethasone.

Detailed description

This study was a single-center, open clinical study. Maternal blood, feces, umbilical venous blood, and placental tissue were collected from GW24-36 Chinese women with preterm labor treated with dexamethasone, excluding placental abruption, severe intrauterine bleeding, or women who met the exclusion criteria. The determination and implementation of dexamethasone treatment by clinicians are executed according to the guidelines, the sample collected in addition to collecting feces and an active medication before an initiative to collect blood after medication, the other is to pregnant women normal diagnosis and treatment after operation opportunity or placental blood collection way, this study does not interfere with the normal of maternal pregnancy, production, and diagnosis and treatment process. A total of 288 Chinese pregnant women with preterm preterm birth who required dexamethasone treatment were randomly divided into eight groups with 36 participants in each group. At admission, blood was retained for each group after biochemical or routine blood test and blood was abandoned once (2 mL). After that, subjects were treated with DEX (5 mg intramuscularization, Q12h, for 2 days, if there was still no delivery 7 days after the first drug administration, another course of treatment or treatment as prescribed by the doctor). During the study period, do not take any food or drugs (such as coffee, alcohol, hypoglycemic drugs and other drugs used with caution or prohibited by pregnant women) that may affect the safety of the fetus. 2 mL of venous blood was collected from each group at 0.5 h, 2 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after the first administration. Blood biochemical or blood routine waste blood at the last prenatal examination was collected in each group, and umbilical venous blood was collected postpartum. Placenta samples were collected postpartum. All samples will be tested for dexamethasone and its metabolite concentrations, pharmacodynamics and safety indicators, hormones and metabolomics. Neonatal development was evaluated by PEABODY score and Bailey Scale at 6 and 24 months postnatal.

Conditions

• Respiratory Distress Syndrome of Newborn
• Threatened Premature Labor, Antepartum

Timeline

• Start date: 2021-12-01
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2022-01-26
• Last updated: 2022-01-26

Locations

1 site across 1 country: China