PreeclampsiaNCT01649128
Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations
An observational study of Preeclampsia, run by CHA University.
Trial summary
For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2011
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: low risk women who had not a risk factor of preeclampsia.
Who may be able to join
- Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea
Who cannot join
- early onset and cases not to measure the sFlt/PlGF ratio and other markers
- twin pregnancy
- Chronic hypertension
- prior history of preeclampsia
- pregestational diabetes mellitus
- gestational diabetes mellitus
Show all 10Show fewer
- patients delivered before 35 weeks of gestation
- preeclamptic patients with onset before 35 weeks of gestation
- patients with body mass index 25kg/m2 or greater
- maternal age 40 years older
About this study
Official title: Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations
For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.
Read the detailed description
A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).
- Conditions
- Preeclampsia
- Keywords
- preeclampsia
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio
Measured: at delivery
Secondary outcomes (1)
identification of patients at risk for late-onset preeclampsia with combined biochemical markers
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Hyun Cha, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649128
- Sponsor's protocol ID
- PrePark
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations
- ClinicalTrials.gov ID
- NCT01649128
- Acronym / sponsor ID
- PrePark
- Conditions
- Preeclampsia
- Keywords
- preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jul 2012 (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.
For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.
Detailed description
A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- low risk women who had not a risk factor of preeclampsia.
Key inclusion criteria (1 listed)
- Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea
Key exclusion criteria (10 listed)
- early onset and cases not to measure the sFlt/PlGF ratio and other markers
- twin pregnancy
- Chronic hypertension
- prior history of preeclampsia
- pregestational diabetes mellitus
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
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio
Time frame: at delivery
1 secondary outcome
identification of patients at risk for late-onset preeclampsia with combined biochemical markers
Time frame: at delivery
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 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by CHA University.
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 1 inclusion and 10 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio (time frame: at 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 Jul 2012.