Understanding Dexamethasone Use in Pregnant Women with Preterm Labor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dongyang Liu
  Beijing, China Recruiting

Study contacts

• Principal investigator: Liu Dongyang — Drug Clinical Trial Center
• Study coordinator: Dongyang Liu
• Email: liudongyang@vip.sina.com
• Phone: （86）010-82266658

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.