Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology (FD)
May 30, 2008 updated by: Hippocration General Hospital
Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases.
310 singleton pregnancies (22-35 weeks) enrolled into the study.
We assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .
Study Overview
Status
Unknown
Conditions
Detailed Description
310 singleton pregnancies (22-35 weeks) enrolled into the study.
We assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .We encountered two cases of hydramnios were no deglutition movements could be noted.
In all other cases the deglutition was normal.
The motivation to conduct the current observational prospective study was to assess whether there is a link between absence of fetal deglutition and CNS pathology of the fetus.
In the first case the fetus deceased at 35 weeks of gestation; obduction was declined by the parents.
In the second case caesarian section at 33 weeks was carried out recently due to fetal distress.
The infant is still in uncapable of swallowing and there for is under investigation at the neonatal center of our hospital.
Study Type
Observational
Enrollment (Actual)
310
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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Thessaloniki, Greece, 54640
- Hippokration General Hospital
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
community sample
Description
Inclusion Criteria:
- singleton pregnancy(22-35 weeks)
Exclusion Criteria:
- positive toxoplasmosis screening,drug and/or antidepressants addiction.
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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1
hydramnios
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2
normal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: THEOHARIS A TANTANASIS, ASSIST PROF, 2nd dept OB/GYN ARISTOTLE UNIV. THESSALONIKI GREECE
- Study Chair: JOHN M TZAFETTAS, PROF, 2nd dept OBGYN ARISTOTLE UNIV. THESSALONIKI GREECE
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
May 1, 2007
Primary Completion (Anticipated)
April 1, 2008
Study Completion (Anticipated)
May 1, 2009
Study Registration Dates
First Submitted
May 28, 2008
First Submitted That Met QC Criteria
May 30, 2008
First Posted (Estimate)
June 2, 2008
Study Record Updates
Last Update Posted (Estimate)
June 2, 2008
Last Update Submitted That Met QC Criteria
May 30, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27052008
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.