Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion
This study has been completed.
Sponsor:
University Hospital, Tours
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00222066
First received: September 19, 2005
Last updated: February 2, 2010
Last verified: September 2006
| Tracking Information | |||||
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| First Received Date ICMJE | September 19, 2005 | ||||
| Last Updated Date | February 2, 2010 | ||||
| Start Date ICMJE | June 2001 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To avoid neonatal surgery [ Time Frame: 3 months after birth ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To avoid neonatal surgery | ||||
| Change History | Complete list of historical versions of study NCT00222066 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion | ||||
| Official Title ICMJE | Comparison Between Abstention and Intrauterine Aspiration in the Treatment of Anechoic Fetal Ovarian Cysts to Prevent Ovarian Torsion | ||||
| Brief Summary | The purpose of this study is to determine whether prenatal ovarian cyst aspiration is effective and safe to prevent perinatal ovarian torsion. |
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| Detailed Description | With the widespread use of routine sonography during pregnancy, the incidence of fetal ovarian cysts detected in utero has increased in the past decades. However |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Fetal ovarian cyst aspiration
Fetal ovarian cyst aspiration performed under ultrasound guidance and maternal local anesthesia |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 61 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00222066 | ||||
| Other Study ID Numbers ICMJE | OV-UTERO 2000 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pr Franck Perrotin, CHRU de Tours | ||||
| Study Sponsor ICMJE | University Hospital, Tours | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Tours | ||||
| Verification Date | September 2006 | ||||
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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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