PreeclampsiaPhase 2/3NCT00928213
PP13 and Doppler Study to Predict Preeclampsia
A Phase 2/3 study testing Progesterone, Low molecular weight Heparin and No Drug in people with Preeclampsia, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Progesterone, Low molecular weight Heparin and No Drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2/3
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women age 16-45 with viable pregnancy as defined by CRL and after signing on an informed consent
- In group 1 all patients meeting the above are eligible when GA is below 14 weeks
- In grop 2 all patients
Who cannot join
- Gestation age at enrolment > 13 weeks and 6 days by LMP verified by ultrasound at blood taking
- Mental retardation or other mental disorders that impose doubts regarding the patient's true willingness to participate in the Study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka Medical Center, Ben Gurion University
Beersheba
Reli Hershkovitz, MD, 972-8-86403070, ralikah@bgu.ac.il
Vered Kivity, PhD, MBA, 972-4-9937722, vered.kivity@pregenesys.com
About this study
Official title: Combined Sonographic Examination and Placenta Protein 13 (PP13) to Compare the Risk for Development of Preeclampsia Among Among Pregnant Women With and Without a History of Preterm Delivery and Those Treated by Progesterone or Clexane
Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood flow through the uterine maternal arteries is assessed.
PP13 is produced by the placenta and released to the maternal blood circulation. It has been shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al., 2005). The purpose of this study is to combined the assessment of the biochemical markers with Doppler in the first and the second trimester to provide a comprehensive evaluation of various methods for sequential and combined analysis to assess the risk for developing preeclampsia.
Read the detailed description
This is a prospective observational study enrolling all comers who attend the prenatal clinic for first trimester assessment of the risk for Down syndrome. All women are providing medical and obstetric history, demography and blood samples along with Doppler pulsatility Index during the first and the second trimester at GA 10-13 weeks and 21-23 weeks. When possible - blood will be drawn at hospital admission for delivery. Measurements of sonography and serum markers are done blinded to pregnancy outcome.
Patients will be assigned to three groups:
- All comers attending the prenatal testing at GA 10-13.
- Patients with a history of at least 2 pregnancy loss or preterm delivery and treated with low molecular weight heparin at 40-80 mg/day from admission to until 12 weeks after delivery.
- Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.
- Conditions
- Preeclampsia
- Being tested
- Progesterone, Low molecular weight Heparin, No Drug
- Keywords
- Preeclampsia, IUGR, GH, PP13, Doppler, placenta, PTD, Preterm delivery
- Medical subject headings
- Pre-Eclampsia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called C-21 steroid hormone, Prometrium
40 units daily admission
Low molecular weight HeparinDrug
Also called clexan
40-80 mg/day
No DrugDrug
Also called No treatment
no treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Control not treated, no placebo Receives: Drug: No Drug |
| 2 | Experimental | Patient treated with low molecular weight heparin after repeated pregnancy loss Receives: Drug: Low molecular weight Heparin |
| 3 | Experimental | Patient super from first trimester bleeding treated with progesterone Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
Measured: pregnancy week >20 till 41 weeks
Secondary outcomes (1)
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death
Measured: fron conception to until a week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Diagnostic Technologies Ltd., Perkin Elmer Inc., Medical University of Graz
- Investigators
- Reli Hershkovitz, MD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928213
- Sponsor's protocol ID
- 972-07-024
- Status last verified
- Jun 2009
- First submitted
- 24 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Sonographic Examination and Placenta Protein 13 (PP13) to Compare the Risk for Development of Preeclampsia Among Among Pregnant Women With and Without a History of Preterm Delivery and Those Treated by Progesterone or Clexane
- ClinicalTrials.gov ID
- NCT00928213
- Acronym / sponsor ID
- 972-07-024
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, IUGR, GH, PP13, Doppler, placenta, PTD, Preterm delivery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Diagnostic Technologies Ltd., Perkin Elmer Inc., Medical University of Graz
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Jun 2009 (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.
Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood flow through the uterine maternal arteries is assessed.
PP13 is produced by the placenta and released to the maternal blood circulation. It has been shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al., 2005). The purpose of this study is to combined the assessment of the biochemical markers with Doppler in the first and the second trimester to provide a comprehensive evaluation of various methods for sequential and combined analysis to assess the risk for developing preeclampsia.
Detailed description
This is a prospective observational study enrolling all comers who attend the prenatal clinic for first trimester assessment of the risk for Down syndrome. All women are providing medical and obstetric history, demography and blood samples along with Doppler pulsatility Index during the first and the second trimester at GA 10-13 weeks and 21-23 weeks. When possible - blood will be drawn at hospital admission for delivery. Measurements of sonography and serum markers are done blinded to pregnancy outcome.
Patients will be assigned to three groups:
- All comers attending the prenatal testing at GA 10-13.
- Patients with a history of at least 2 pregnancy loss or preterm delivery and treated with low molecular weight heparin at 40-80 mg/day from admission to until 12 weeks after delivery.
- Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: No DrugControl not treated, no placebo |
| 2 | Experimental | Drug: Low molecular weight HeparinPatient treated with low molecular weight heparin after repeated pregnancy loss |
| 3 | Experimental | Drug: ProgesteronePatient super from first trimester bleeding treated with progesterone |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women age 16-45 with viable pregnancy as defined by CRL and after signing on an informed consent
- In group 1 all patients meeting the above are eligible when GA is below 14 weeks
- In grop 2 all patients
Key exclusion criteria (2 listed)
- Gestation age at enrolment > 13 weeks and 6 days by LMP verified by ultrasound at blood taking
- Mental retardation or other mental disorders that impose doubts regarding the patient's true willingness to participate in the Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneAlso: C-21 steroid hormone, Prometrium40 units daily admission | Drug | 3 |
| Low molecular weight HeparinAlso: clexan40-80 mg/day | Drug | 2 |
| No DrugAlso: No treatmentno treatment | Drug | 1 |
Primary outcome
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
Time frame: pregnancy week >20 till 41 weeks
1 secondary outcome
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death
Time frame: fron conception to until a week after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
- The website of Ben Gurion UniversityLink provided by the sponsor.
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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.
Reli Hershkovitz, MD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Progesterone, Low molecular weight Heparin and No Drug in people with Preeclampsia, run by Ben-Gurion University of the Negev at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 25 Jun 2009. 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 Israel. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reli Hershkovitz, MD (972-8-6403070, ralika@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection (time frame: pregnancy week >20 till 41 weeks). 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 Jun 2009.