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Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology (FD)

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ClinicalTrials.gov Identifier: NCT00687752
Recruitment Status : Unknown
Verified May 2008 by Hippocration General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 2, 2008
Last Update Posted : June 2, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 .

Condition or disease
Hydramnios

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 Design

Study Type : Observational
Actual Enrollment : 310 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases.
Study Start Date : May 2007
Estimated Primary Completion Date : April 2008
Estimated Study Completion Date : May 2009
Groups and Cohorts

Group/Cohort
1
hydramnios
2
normal


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • singleton pregnancy(22-35 weeks)

Exclusion Criteria:

  • positive toxoplasmosis screening,drug and/or antidepressants addiction.
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): NCT00687752


Locations
Greece
Hippokration General Hospital
Thessaloniki, Greece, 54640
Sponsors and Collaborators
Hippocration General Hospital
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
More Information

Responsible Party: assist. professor THEOHARIS TANTANASIS, 2nd department OB/GYN Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT00687752     History of Changes
Other Study ID Numbers: 27052008
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: June 2, 2008
Last Verified: May 2008

Keywords provided by Hippocration General Hospital:
fetal deglutition
larynx
fetal CNS pathology
sonography
hydramnios

Additional relevant MeSH terms:
Polyhydramnios
Pregnancy Complications