PP13 and Doppler Study to Predict Preeclampsia
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Preeclampsia |
Drug: Progesterone Drug: Low molecular weight Heparin Drug: No Drug |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| 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 |
- Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection [ Time Frame: pregnancy week >20 till 41 weeks ] [ Designated as safety issue: No ]
- intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death [ Time Frame: fron conception to until a week after delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Control not treated, no placebo
|
Drug: No Drug
no treatment
Other Name: No treatment
|
|
Experimental: 2
Patient treated with low molecular weight heparin after repeated pregnancy loss
|
Drug: Low molecular weight Heparin
40-80 mg/day
Other Name: clexan
|
|
Experimental: 3
Patient super from first trimester bleeding treated with progesterone
|
Drug: Progesterone
40 units daily admission
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Reli Hershkovitz, MD | 972-8-6403070 | ralika@bgu.ac.il |
| Contact: Vered Kivity, PhD, MBA | 972-4-9937722 ext 0 | vered.kivity@pregesys.com |
| Israel | |
| Soroka Medical Center, Ben Gurion University | Not yet recruiting |
| Beer-Sheva, Israel | |
| Contact: Reli Hershkovitz, MD 972-8-86403070 ralikah@bgu.ac.il | |
| Contact: Vered Kivity, PhD, MBA 972-4-9937722 vered.kivity@pregenesys.com | |
| Principal Investigator: Reli Hershkovitz, MD | |
| Principal Investigator: | Reli Hershkovitz, MD | Ben-Gurion University of the Negev |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Reli Hershkovitz, Soroka Medical Center Ben Gurion University |
| ClinicalTrials.gov Identifier: | NCT00928213 History of Changes |
| Other Study ID Numbers: | 972-07-024 |
| Study First Received: | June 24, 2009 |
| Last Updated: | June 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ben-Gurion University of the Negev:
|
Preeclampsia IUGR GH PP13 |
Doppler placenta PTD Preterm delivery |
Additional relevant MeSH terms:
|
Pre-Eclampsia Premature Birth Hypertension, Pregnancy-Induced Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Heparin Heparin, Low-Molecular-Weight Dalteparin Progesterone Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013