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

Hydramnios Clinical Trial

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Official title:

Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00687752
• Other study ID #: 27052008
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 28, 2008
• Last updated: May 30, 2008
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2008
• Source: Hippocration General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 310
• Est. completion date: May 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• singleton pregnancy(22-35 weeks)

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hydramnios

Locations

Country	Name	City	State
Greece	Hippokration General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Country where clinical trial is conducted

Greece,