PregnancyPlGFNCT01387776
Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21
An observational study of Pregnancy, run by Clinique Ovo at 1 site in Canada.
Trial summary
This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 370 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2015
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women in 1st trimester of pregnancy coming to clinique OVO for prenatal screening
Who may be able to join
- Singleton pregnancy
- Nulliparous pregnancy
- Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
- Blood sample provided at gestational age 6.0-13.6 weeks
- Informed Consent
Who cannot join
- Multi-fetal pregnancy
- Primiparous or multiparous pregnancy
- Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
- Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
- Lack of blood sample at the specified enrollment period
- Known major fetal anomaly or fetal demise
- Lack of demographic data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study for the Evaluation of the Benefits of 1 st Trimester Risk Markers in Detecting Early Onset Pre-eclampsia and the Use of the Placental Growth Factor (PlGF) as a Potential Marker for Trisomy 21 and Other Aneuploidies
This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.
Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.
- Conditions
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients coming to clinique OVO in the 1st trimester of pregnancy to undergo prenatal screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF
levels of PP13, PIGF, PAPP-A will de considered in association with Doppler ultrasound and standardised blood pressure measurements to see if they can be used as early risk markers in patients having a delivery before 34 weeks gestation
Measured: 6-13.6 wks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: The technique has been approved and validated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Hemmings, MD, Principal investigator, Clinique OvoBernard Couturier, MD, Study director, Clinique OvoDominique Berube, PhD, Study chair, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387776
- Sponsor's protocol ID
- B-PRN-10-01
- Acronym
- PlGF
- Status last verified
- Jul 2015
- First submitted
- 31 Jan 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Evaluation of the Benefits of 1 st Trimester Risk Markers in Detecting Early Onset Pre-eclampsia and the Use of the Placental Growth Factor (PlGF) as a Potential Marker for Trisomy 21 and Other Aneuploidies
- ClinicalTrials.gov ID
- NCT01387776
- Acronym / sponsor ID
- PlGF / B-PRN-10-01
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The technique has been approved and validated
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Jul 2011 (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.
This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.
Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients coming to clinique OVO in the 1st trimester of pregnancy to undergo prenatal screening |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women in 1st trimester of pregnancy coming to clinique OVO for prenatal screening
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Nulliparous pregnancy
- Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
- Blood sample provided at gestational age 6.0-13.6 weeks
- Informed Consent
Key exclusion criteria (7 listed)
- Multi-fetal pregnancy
- Primiparous or multiparous pregnancy
- Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
- Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
- Lack of blood sample at the specified enrollment period
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
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF
Time frame: 6-13.6 wks gestation
levels of PP13, PIGF, PAPP-A will de considered in association with Doppler ultrasound and standardised blood pressure measurements to see if they can be used as early risk markers in patients having a delivery before 34 weeks gestation
Results and safety
The study was stopped early (reason given: The technique has been approved and validated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Robert Hemmings, MD principal investigator
Clinique Ovo
Bernard Couturier, MD study director
Clinique Ovo
Dominique Berube, PhD study chair
Clinique Ovo
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 Pregnancy, run by Clinique Ovo at 1 site in Canada.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Jul 2015. 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 Canada. 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 was stopped early (reason given: The technique has been approved and validated). Results are not available in the source record.
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?
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF (time frame: 6-13.6 wks gestation). 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 28 Jul 2015.