Preterm LaborNCT01916330
Development of Pharmacokinetics Model in Pregnancy Women and Fetus
An observational study of Preterm Labor and Preterm Premature Rupture of Membrane (PPROM), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Preterm Labor, Preterm Premature Rupture of Membrane (PPROM)
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jan 2013to 24 Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: preterm labor, PPROM in pregnant women from tertiary university hospital
Who may be able to join
- 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)
Who cannot join
- who deny the study entrance
- who administered study drug before transfer to tertiary hospital
Trial locations and contacts
1 site in 1 country.
About this study
Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus
- Medical subject headings
- Obstetric Labor, Premature, Preterm Premature Rupture of the Membranes
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of drug concentration
drug (dexamethasone, clarithromycin)
Measured: Day 1 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start14 Jan 2013
- Primary completion24 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joong Shin Park, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916330
- Sponsor's protocol ID
- SNUHOB-PK1
- Status last verified
- Apr 2019
- First submitted
- 29 Jul 2013
- Last updated
- 25 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Pharmacokinetics Model in Pregnancy Women and Fetus
- ClinicalTrials.gov ID
- NCT01916330
- Acronym / sponsor ID
- SNUHOB-PK1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 24 Feb 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- preterm labor, PPROM in pregnant women from tertiary university hospital
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- who deny the study entrance
- who administered study drug before transfer to tertiary hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of drug concentration
Time frame: Day 1 after delivery
drug (dexamethasone, clarithromycin)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joong Shin Park, MD PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Preterm Premature Rupture of Membrane (PPROM), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of drug concentration (time frame: Day 1 after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.