PP13 and Doppler Study to Predict Preeclampsia

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928213

Enrollment

1000

Registered

2009-06-25

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, IUGR, GH, PP13, Doppler, placenta, PTD, Preterm delivery

Brief 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). 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: 1. All comers attending the prenatal testing at GA 10-13. 2. 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. 3. Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.

Interventions

DRUGProgesterone

40 units daily admission

DRUGLow molecular weight Heparin

40-80 mg/day

DRUGNo Drug

no treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection	pregnancy week >20 till 41 weeks

Secondary

Measure	Time frame
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death	fron conception to until a week after delivery

Countries

Israel

Contacts

Primary ContactReli Hershkovitz, MD

ralika@bgu.ac.il972-8-6403070

Backup ContactVered Kivity, PhD, MBA

vered.kivity@pregesys.com972-4-9937722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026