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

NCT ID: NCT00687752

Last Updated: 2008-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-05-31

Brief Summary

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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 .

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Detailed Description

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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.

Conditions

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Hydramnios

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

hydramnios

No interventions assigned to this group

2

normal

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy(22-35 weeks)

Exclusion Criteria

* positive toxoplasmosis screening,drug and/or antidepressants addiction.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hippocration General Hospital

OTHER

Sponsor Role lead

Responsible Party

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2nd department OB/GYN Hippocration General Hospital

Principal Investigators

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THEOHARIS A TANTANASIS, ASSIST PROF

Role: PRINCIPAL_INVESTIGATOR

2nd dept OB/GYN ARISTOTLE UNIV. THESSALONIKI GREECE

JOHN M TZAFETTAS, PROF

Role: STUDY_CHAIR

2nd dept OBGYN ARISTOTLE UNIV. THESSALONIKI GREECE

Locations

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Hippokration General Hospital

Thessaloniki, THESSALONIKI, Greece

Site Status

Countries

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Greece

Other Identifiers

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27052008

Identifier Type: -

Identifier Source: org_study_id

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