NCT01916330

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2014

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

July 29, 2013

Last Update Submit

April 23, 2019

Conditions

Preterm LaborPreterm Premature Rupture of Membrane (PPROM)

Outcome Measures

Primary Outcomes (1)

  • Analysis of drug concentration

    drug (dexamethasone, clarithromycin)

    Day 1 after delivery

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

preterm labor, PPROM in pregnant women from tertiary university hospital

You may qualify if:

  • \<= 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

MeSH Terms

Conditions

Obstetric Labor, PrematurePreterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Joong Shin Park, MD PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

August 5, 2013

Study Start

January 14, 2013

Primary Completion

February 24, 2014

Last Updated

April 25, 2019

Record last verified: 2019-04

Locations

KR(1)