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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
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center Identifier:
First received: January 8, 2014
Last updated: January 30, 2014
Last verified: December 2013
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.

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)
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


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

Inclusion Criteria:

  • pregnant women from 11 -14 weeks of gestation

Exclusion Criteria:

  • nuchal thickness above 3 mm,
  • Chronic hypertension,
  • thrombophilia,
  • Diabetes
  Contacts and Locations
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Please refer to this study by its identifier: NCT02031393

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 Identifier: NCT02031393     History of Changes
Other Study ID Numbers: 217/13
Study First Received: January 8, 2014
Last Updated: January 30, 2014

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on September 21, 2017