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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 28, 2008 | ||||||||
| Last Updated Date | May 30, 2008 | ||||||||
| Start Date ICMJE | May 2007 | ||||||||
| Estimated Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00687752 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology | ||||||||
| Official Title ICMJE | Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases. | ||||||||
| Brief 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 . |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE | Hydramnios | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Enrollment ICMJE | 310 | ||||||||
| Estimated Completion Date | May 2009 | ||||||||
| Estimated Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Greece | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00687752 | ||||||||
| Responsible Party | assist. professor THEOHARIS TANTANASIS, 2nd department OB/GYN Hippocration General Hospital | ||||||||
| Study ID Numbers ICMJE | 27052008 | ||||||||
| Study Sponsor ICMJE | Hippocration General Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Hippocration General Hospital | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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