Establishing First Trimester Markers for the Identification of High Risk Twin

January 30, 2014 updated by: Assaf-Harofeh Medical Center

Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester

The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Zrifin
      • Be'er Ya'aqov, Zrifin, Israel, 70300
        • Assaf Harofe obstetric department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig

Description

Inclusion Criteria:

  • pregnant women from 11 -14 weeks of gestation

Exclusion Criteria:

  • nuchal thickness above 3 mm,
  • Chronic hypertension,
  • thrombophilia,
  • Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
singelton pregnancy
will be followed 11-14 weeks and 19-28 weeks of gestation and after birth
twin pregnancy
will be followed 11-14 weeks and 19-28 weeks of gestation and after birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The development of preeclampsia
Time Frame: after delivery
the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension
after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
intra uterine growth restriction
Time Frame: after delivery
after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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