Development of Pharmacokinetics Model in Pregnancy Women and Fetus

April 23, 2019 updated by: Seoul National University Hospital
Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

preterm labor, PPROM in pregnant women from tertiary university hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of drug concentration
Time Frame: Day 1 after delivery
drug (dexamethasone, clarithromycin)
Day 1 after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Joong Shin Park, MD PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2013

Primary Completion (Actual)

February 24, 2014

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHOB-PK1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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