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Sponsored by: |
Hippocration General Hospital |
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Information provided by: | Hippocration General Hospital |
ClinicalTrials.gov Identifier: | NCT00687752 |
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 |
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Hydramnios |
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. |
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 |
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1
hydramnios
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2
normal
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
community sample
Inclusion Criteria:
Exclusion Criteria:
Greece | |
Hippokration General Hospital | |
THESSALONIKI, Greece, 54640 |
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 |
Responsible Party: | 2nd department OB/GYN Hippocration General Hospital ( assist. professor THEOHARIS TANTANASIS ) |
Study ID Numbers: | 27052008 |
Study First Received: | May 28, 2008 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00687752 |
Health Authority: | Greece: Ethics Committee |
fetal deglutition larynx fetal CNS pathology sonography hydramnios |
Pregnancy Complications Polyhydramnios |