Establishing First Trimester Markers for the Identification of High Risk Twin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT02031393
First received: January 8, 2014
Last updated: January 30, 2014
Last verified: December 2013
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031393

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

No publications provided

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02031393     History of Changes
Other Study ID Numbers: 217/13
Study First Received: January 8, 2014
Last Updated: January 30, 2014
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on September 22, 2014