Understanding Dexamethasone Use in Pregnant Women with Preterm Labor

Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

This study is testing how the medication dexamethasone affects pregnant women in preterm labor and their babies to help figure out the safest way to use it.

Quick facts

• Study type: Observational
• Enrollment: 288 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05207852 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the pharmacokinetics of dexamethasone in pregnant women experiencing preterm labor. It involves collecting maternal blood, feces, umbilical venous blood, and placental tissue from Chinese women between 24 to 36 weeks of gestation who are treated with dexamethasone. The study will analyze how the drug affects fetal lung maturity and gather data to inform safe and effective dosing guidelines. A total of 288 participants will be monitored to assess the drug's impact without interfering with their normal pregnancy care.

Who should consider this trial

Good fit: Ideal candidates are Chinese pregnant women aged 20-40 with a BMI of 18.5-27.9 and experiencing preterm labor between 24-36 weeks.

Not a fit: Patients with ectopic pregnancies, serious infections, or those who have recently taken glucocorticoids will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safe use of dexamethasone to enhance fetal lung maturity in preterm infants.

How similar studies have performed: While there have been studies on dexamethasone in pregnancy, this specific pharmacokinetic approach in a Chinese population is relatively novel.

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.

Where this trial is running

Beijing

• Dongyang Liu — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Liu Dongyang — Drug Clinical Trial Center
• Study coordinator: Dongyang Liu

Conditions Respiratory Distress Syndrome of Newborn; Threatened Premature Labor, Antepartum; Dexamethasone; Pregnancy; Preterm; Quantitative pharmacology; P-glycoprotein