- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02031393
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
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
-
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Zrifin
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Be'er Ya'aqov, Zrifin, Israel, 70300
- Assaf Harofe obstetric department
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-
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 |
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singelton pregnancy
will be followed 11-14 weeks and 19-28 weeks of gestation and after birth
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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
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after delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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