Development of Pharmacokinetics Model in Pregnancy Women... | NCT01916330

Studies
Development of Pharmacokinetics Model in Pregnancy Women and Fetus

NCT01916330

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 25, 2019Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Preterm Labor
Preterm Premature Rupture of Membrane (PPROM)

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2013Actual

Primary Completion Date

Feb 24, 2014Actual

Completion Date

Not provided

First Submitted Date

Jul 29, 2013

First Submission Date that Met QC Criteria

Aug 2, 2013

First Posted Date

Aug 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2019

Last Update Posted Date

Apr 25, 2019Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

preterm labor, PPROM in pregnant women from tertiary university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joong Shin Park, MD PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature
C563032	Preterm Premature Rupture of the Membranes

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided