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Establishing First Trimester Markers for the Identification of High Risk Twin

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02031393
First Posted: January 9, 2014
Last Update Posted: January 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
  Purpose
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.

Condition
Small for Gestational Age (Disorder) Pre-Eclampsia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • intra uterine growth restriction [ Time Frame: after delivery ]

Biospecimen Retention:   Samples Without DNA
Maternal serum

Estimated Enrollment: 300
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women that will come to our first trimester clinic inorder to preform first trimester screeninig
Criteria

Inclusion Criteria:

  • pregnant women from 11 -14 weeks of gestation

Exclusion Criteria:

  • nuchal thickness above 3 mm,
  • Chronic hypertension,
  • thrombophilia,
  • Diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031393


Locations
Israel
Assaf Harofe obstetric department
Be'er Ya`aqov, Zrifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02031393     History of Changes
Other Study ID Numbers: 217/13
First Submitted: January 8, 2014
First Posted: January 9, 2014
Last Update Posted: January 31, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications