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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hippocration General Hospital
ClinicalTrials.gov Identifier:
NCT00687752
First received: May 28, 2008
Last updated: May 30, 2008
Last verified: May 2008
History of Changes
  Purpose

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
Hydramnios

Study Type: Observational
Study Design: 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.

Further study details as provided by Hippocration General Hospital:

Enrollment: 310
Study Start Date: May 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
hydramnios
2
normal

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.

  Eligibility

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

No publications provided

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
Study First Received: May 28, 2008
Last Updated: May 30, 2008
Health Authority: Greece: Ethics Committee

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

Additional relevant MeSH terms:
Polyhydramnios
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013