Development of Pharmacokinetics Model in Pregnancy Women and Fetus

Completed

• Conditions: Preterm Labor; Preterm Premature Rupture of Membrane (PPROM)

• Registration Number: NCT01916330
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-14
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Primary Completion: 2014-02-24
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• 20 <= age < 50
• pregnant women who were administered intramuscular dexamethasone (ex) preterm labor)
• pregnant women who were administered PO clarithromycin (ex) PPROM/intrauterine infection or inflammation)

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Exclusion Criteria

• who deny the study entrance
• who administered study drug before transfer to tertiary hospital

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of drug concentration	Day 1 after delivery	drug (dexamethasone, clarithromycin)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of