Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

Launched by DONGYANG LIU · Jan 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how the medication dexamethasone affects pregnant women who are at risk of giving birth early, between 24 and 36 weeks of pregnancy. The researchers want to understand how the drug works in the bodies of pregnant women and how it can help develop the lungs of their babies, which is important for newborns at risk of respiratory problems. By collecting information on how dexamethasone is processed in the body, the study aims to provide guidelines for its safe and effective use.

To participate in this trial, women aged 20 to 40 years old who are having a single or twin pregnancy and are at risk of preterm labor may be eligible. Participants should not have used certain medications or experienced specific health issues that could affect the study outcome. Those who join will receive dexamethasone injections every 12 hours to help their baby's lung development. It's important to note that there are strict criteria for participation to ensure the safety of both the mother and the baby.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.