Actively Recruiting

Age: 20Years - 40Years
FEMALE
NCT05207852

Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

Led by Dongyang Liu · Updated on 2022-01-26

288

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

Who Can Participate

Age: 20Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 20-40 years (inclusive)
  • Body mass index (BMI) between 18.5 and 27.9 kg/m2 (inclusive)
  • Single or twin pregnancy
  • Premature labor occurring between 24 and 36 weeks of pregnancy
  • No use of antibiotics, prebiotics, or probiotics within one month before feces collection
  • Approximately 10% of participants may have preeclampsia
  • Use of intramuscular dexamethasone 5 mg every 12 hours (or other dexamethasone regimens) to promote fetal lung maturation
Not Eligible

You will not qualify if you...

  • Ectopic pregnancy
  • Diabetes, fetal distress, serious infections such as sepsis or septic shock, or fever
  • Use of glucocorticoid drugs within 2 weeks before joining the study
  • Use of clindamycin during the study period
  • Congenital fetal malformation or fetal hypoxia in early pregnancy
  • History of convulsions
  • HIV, hepatitis C virus, hepatitis A, or history of drug abuse
  • Chorioamnionitis or endometritis
  • Placental abruption or severe intrauterine bleeding
  • Cervical dilation of 4 cm or more, or cervical length of 20 mm or less by ultrasound
  • Use of food or drugs during the study that might affect fetal safety
  • Participation in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dongyang Liu

Beijing, China, 100191

Actively Recruiting

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Research Team

D

Dongyang Liu

CONTACT

S

Song Jie

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

8

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