Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | February 26, 2010 | ||||
| Last Updated Date | October 12, 2012 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Establishment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ] [ Designated as safety issue: No ] Establishment of physiological reference range of placental perfusion |
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| Original Primary Outcome Measures ICMJE |
Establisment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01092949 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 | Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE | ||||
| Official Title ICMJE | Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE | ||||
| Brief Summary | To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center. |
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| Detailed Description | Objective: To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center. Method: All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study. 120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG. MRI will be performed in the same hospital, during hospital stay, within 45 minutes. Two MRI sequences will be used to measure placental perfusion:
Duration of inclusion: 24 months. Duration of patient participation: 45 minutes. Expected results:
Adverse outcome measure: Nausea, vomiting, lack of comfort and other adverse outcome. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study. |
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| Condition ICMJE | Placental Insufficiency | ||||
| Intervention ICMJE | Device: MRI
MRI, 45 minutes
Other Name: MRI, 45 minutes |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | February 2013 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01092949 | ||||
| Other Study ID Numbers ICMJE | P 081111, 2009-A01024-63 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | February 2011 | ||||
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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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