HydramniosFDNCT00687752
Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology
An observational study of Hydramnios, run by Hippocration General Hospital at 1 site in Greece.
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 . Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hydramnios
- How many people
- 310 participants
- Where
- 1 siteGreece
- Study dates
- May 2007to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- singleton pregnancy(22-35 weeks)
Who cannot join
- positive toxoplasmosis screening,drug and/or antidepressants addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases.
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 .
Read the 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.
- Conditions
- Hydramnios
- Keywords
- fetal deglutition, larynx, fetal CNS pathology, sonography, hydramnios
- Medical subject headings
- Polyhydramnios, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | hydramnios | |
| 2 | normal |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionApr 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydramniosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- THEOHARIS A TANTANASIS, ASSIST PROF, Principal investigator, 2nd dept OB/GYN ARISTOTLE UNIV. THESSALONIKI GREECEJOHN M TZAFETTAS, PROF, Study chair, 2nd dept OBGYN ARISTOTLE UNIV. THESSALONIKI GREECE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687752
- Sponsor's protocol ID
- 27052008
- Acronym
- FD
- Status last verified
- May 2008
- First submitted
- 28 May 2008
- Last updated
- 2 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of CNS Pathology? a Report on Two Cases.
- ClinicalTrials.gov ID
- NCT00687752
- Acronym / sponsor ID
- FD / 27052008
- Conditions
- Hydramnios
- Keywords
- fetal deglutition, larynx, fetal CNS pathology, sonography, hydramnios
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –hydramnios |
| 2 | – | –normal |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- singleton pregnancy(22-35 weeks)
Key exclusion criteria (1 listed)
- positive toxoplasmosis screening,drug and/or antidepressants addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2008.
Related trials for Hydramnios
Not yet recruitingObservational study
Amnioreduction in Polyhydramnios
Polyhydramnios
Recruiting
"Fetal gRowth AbnorMality dEtection Trial"
Small for Gestational Age Infant, Large for Gestational Age Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
THEOHARIS A TANTANASIS, ASSIST PROF principal investigator
2nd dept OB/GYN ARISTOTLE UNIV. THESSALONIKI GREECE
JOHN M TZAFETTAS, PROF study chair
2nd dept OBGYN ARISTOTLE UNIV. THESSALONIKI GREECE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydramnios, run by Hippocration General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2008.