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

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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:

Biospecimen Retention: None Retained

Biospecimen Description:

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

Responsible Party:	2nd department OB/GYN Hippocration General Hospital ( assist. professor THEOHARIS TANTANASIS )
Study ID Numbers:	27052008
First Received:	May 28, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00687752
Health Authority:	Greece: Ethics Committee

Keywords provided by Hippocration General Hospital:

fetal deglutition

larynx

fetal CNS pathology

sonography

hydramnios

Study placed in the following topic categories:

Pregnancy Complications

Polyhydramnios

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hippocration General Hospital
Information provided by:	Hippocration General Hospital
ClinicalTrials.gov Identifier:	NCT00687752