Status:
RECRUITING
Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor
Lead Sponsor:
Dongyang Liu
Conditions:
Respiratory Distress Syndrome of Newborn
Threatened Premature Labor, Antepartum
Eligibility:
FEMALE
20-40 years
Brief 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 dexam...
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 dexam...
Eligibility Criteria
Inclusion
- Aged 20-40 (inclusive);
- Body mass Index (BMI) 18.5-27.9kg /m2 (inclusive)
- Single and twin pregnancy;
- Premature delivery at 24-36 weeks;
- No antibiotics, prebiotics or probiotics were used one month before feces collection (such as Bifidobacterium triplex live powder, Lactobacillus acidophilus tablet, compound Lactobacillus acidophilus tablet, Bacillus subtilis diplex live intestinal capsule, etc.);
- Preeclampsia patients accounted for about 1/10 of each group;
- Use dexamethasone I.M. 5mg Q12h regimen (or other dexamethasone administration regimen) to promote fetal lung maturation.
Exclusion
- Ectopic pregnancy;
- Suffering from diabetes, fetal distress, serious infectious diseases (such as sepsis, septic shock), fever;
- Those who have taken glucocorticoid drugs within 2 weeks before joining the clinical trial;
- Those who took clindamycin during the study period;
- Congenital fetal malformation or fetal hypoxia in early pregnancy;
- Convulsive patients;
- HIV/HCV/ HEPATITIS A, drug abuse history;
- Suffering from chorioamnitis, endometritis;
- Placental abruption, severe intrauterine bleeding;
- Pregnant women whose cervical dilation is greater than or equal to 4 cm or whose cervical length is less than or equal to 20 mm by ultrasound examination;
- Pregnant women who took food or drugs during the study that might affect the safety of the fetus;
- Pregnant women participating in other clinical trials.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT05207852
Start Date
December 1 2021
End Date
December 31 2027
Last Update
January 26 2022
Active Locations (1)
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1
Dongyang Liu
Beijing, China, 100191