Pregnant WomenNCT03407807
Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution
An observational study of Pregnant Women, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- How many people
- 5,450 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Sep 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnent women with an isolated suspected fetal splenic cyst
Who may be able to join
- Pregnent women with an isolated suspected fetal splenic cyst between 2007 and 2017 in Montpellier Prenatal Diagnosis Center
Who cannot join
- All others fetal diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst
Read the detailed description
The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst. The investigators performed a retrospective study in the Montpellier Prenatal Diagnosis Centre between 2007 and 2017. All pregnant women referred to this unit after routine ultrasound examination with a suspected splenic cyst were included. Participant all benefit a reference ultrasound to perform a detailed morphological examination. In any doubt about diagnosis, a MRI exam wad proposed. Then patient were followed regularly. At birth, all newborn babys had medical examination to search early complication. Then, children had a surgical consultation and regular ultrasound examinations were performed.
- Conditions
- Pregnant Women
- Keywords
- Fetal Splenic cyst, Differential Diagnosis, Evolution and complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal ultrasound evolution of fetal splenic cysts during pregnancy
Prenatal ultrasound evolution of fetal splenic cysts during pregnancy: persistence, increasing/decreasing in size, disappearance
Measured: 1 day
Secondary outcomes (5)
Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst
Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst (persistence, increasing/decreasing in size, disappearance)
Measured: 1 year
Post natal ultrasound evolution at birth of the cyst
Post natal ultrasound evolution at birth of the cyst : persistence, increasing/decreasing in size, disappearance
Measured: 1 year
Post natal MRI evolution at birth of the cyst
Post natal MRI evolution at birth of the cyst : persistence, increasing/decreasing in size, disappearance
Measured: 1 year
1 year ultrasound evolution of the cyst
1 year ultrasound evolution of the cyst : persistence, increasing/decreasing in size, disappearance
Measured: 1 year
1 year MRI evolution of the cyst
1 year MRI evolution of the cyst : persistence, increasing/decreasing in size, disappearance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startJan 2017
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407807
- Sponsor's protocol ID
- RECHMPL17_0331
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution
- ClinicalTrials.gov ID
- NCT03407807
- Acronym / sponsor ID
- RECHMPL17_0331
- Conditions
- Pregnant Women
- Keywords
- Fetal Splenic cyst, Differential Diagnosis, Evolution and complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,450 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst
Detailed description
The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst. The investigators performed a retrospective study in the Montpellier Prenatal Diagnosis Centre between 2007 and 2017. All pregnant women referred to this unit after routine ultrasound examination with a suspected splenic cyst were included. Participant all benefit a reference ultrasound to perform a detailed morphological examination. In any doubt about diagnosis, a MRI exam wad proposed. Then patient were followed regularly. At birth, all newborn babys had medical examination to search early complication. Then, children had a surgical consultation and regular ultrasound examinations were performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnent women with an isolated suspected fetal splenic cyst
Key inclusion criteria (1 listed)
- Pregnent women with an isolated suspected fetal splenic cyst between 2007 and 2017 in Montpellier Prenatal Diagnosis Center
Key exclusion criteria (1 listed)
- All others fetal diagnosis
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
Prenatal ultrasound evolution of fetal splenic cysts during pregnancy
Time frame: 1 day
Prenatal ultrasound evolution of fetal splenic cysts during pregnancy: persistence, increasing/decreasing in size, disappearance
5 secondary outcomes
Prenatal Magnetic Resonance imaging (MRI) evolution of fetal splenic cyst
Time frame: 1 year
Post natal ultrasound evolution at birth of the cyst
Time frame: 1 year
Post natal MRI evolution at birth of the cyst
Time frame: 1 year
1 year ultrasound evolution of the cyst
Time frame: 1 year
1 year MRI evolution of the cyst
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnant Women, run by University Hospital, Montpellier at 1 site in France.
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: finished, as of the sponsor's last update on 23 Jan 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Prenatal ultrasound evolution of fetal splenic cysts during pregnancy (time frame: 1 day). It is what the study was designed to measure, not a finding.
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 23 Jan 2018.