Actively Recruiting
Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor
Led by Dongyang Liu · Updated on 2022-01-26
288
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 20-40 years (inclusive)
- Body mass index (BMI) between 18.5 and 27.9 kg/m2 (inclusive)
- Single or twin pregnancy
- Premature labor occurring between 24 and 36 weeks of pregnancy
- No use of antibiotics, prebiotics, or probiotics within one month before feces collection
- Approximately 10% of participants may have preeclampsia
- Use of intramuscular dexamethasone 5 mg every 12 hours (or other dexamethasone regimens) to promote fetal lung maturation
You will not qualify if you...
- Ectopic pregnancy
- Diabetes, fetal distress, serious infections such as sepsis or septic shock, or fever
- Use of glucocorticoid drugs within 2 weeks before joining the study
- Use of clindamycin during the study period
- Congenital fetal malformation or fetal hypoxia in early pregnancy
- History of convulsions
- HIV, hepatitis C virus, hepatitis A, or history of drug abuse
- Chorioamnionitis or endometritis
- Placental abruption or severe intrauterine bleeding
- Cervical dilation of 4 cm or more, or cervical length of 20 mm or less by ultrasound
- Use of food or drugs during the study that might affect fetal safety
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dongyang Liu
Beijing, China, 100191
Actively Recruiting
Research Team
D
Dongyang Liu
CONTACT
S
Song Jie
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
8
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