RecruitingNot Applicable

Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

China288 participantsStarted 2021-12-01

Plain-language 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 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.

Who can participate

Age range

20 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Respiratory distress syndrome

Timeframe: At birth

hypoglycemia

Timeframe: Within 24 hours of birth

PEABODY

Timeframe: Six months

PEABODY

Timeframe: Two years

BayleyScales of Infant and Toddler Development

Timeframe: Six months

BayleyScales of Infant and Toddler Development

Timeframe: Two years

Trial details

NCT IDNCT05207852

SponsorDongyang Liu

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Dongyang Liu

（86）010-82266658 liudongyang@vip.sina.com

View on ClinicalTrials.gov More Respiratory Distress Syndrome of Newborn trials