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NCT01916330 Clinical Trial

Development of Pharmacokinetics Model in Pregnancy Women and Fetus

Preterm Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01916330
Other study ID # SNUHOB-PK1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2013

Study information
Verified date April 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date
Est. primary completion date February 24, 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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)

Exclusion Criteria:

- who deny the study entrance

- who administered study drug before transfer to tertiary hospital

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of drug concentration drug (dexamethasone, clarithromycin) Day 1 after delivery
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