PP13 and Doppler Study to Predict Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Use of Placenta Protein 13 (PP13) in the First Trimester of Pregnancy as a Diagnostic Aiding Tool in the Assessment of the Risk for Developing Preeclampsia in Women With Low and Unknown Risk

NCT00572793

Preeclampsia

COMPLETED

Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia

NCT02350036

Preeclampsia

COMPLETED

Relation Between Protein 13 and Gestational Hypertensive Disorder

NCT05517512

Gestational Hypertension

COMPLETED

The Prediction of Preeclampsia/Toxemia in Twin Pregnancy

NCT01255202

Preeclampsia/Toxemia

UNKNOWN

First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

NCT02379494

Preeclampsia Fetal Growth Restriction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preeclampsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Control not treated, no placebo

Group Type EXPERIMENTAL

No Drug

Intervention Type DRUG

no treatment

2

Patient treated with low molecular weight heparin after repeated pregnancy loss

Group Type EXPERIMENTAL

Low molecular weight Heparin

Intervention Type DRUG

40-80 mg/day

3

Patient super from first trimester bleeding treated with progesterone

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

40 units daily admission

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Progesterone

40 units daily admission

Intervention Type DRUG

Low molecular weight Heparin

40-80 mg/day

Intervention Type DRUG

No Drug

no treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

C-21 steroid hormone Prometrium clexan No treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No