NCT03600636已完成不适用
Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年12月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean diffusivity of white matter between groups
研究概览
简要总结
The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is at least 18 years old
- •For the target population: only women included in the publication by Pereira et al (2016) will be included, with no obsteric history (fetal death >10 weeks or 3 unexplained consecutive losses <10 weeks)
- •For the test group: Patients must be positive for antiphospholipid antibodies based on results from Pereira et al (2016)
- •For the control group. Patients must be negative for antiphospholipid antibodies according to results from Pereira et al (2016)
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant, parturient or breast feeding
- •The patient is claustrophobic
- •The patient has a metallic foreign body (e.g. pacemaker)
- •The patient has experienced pregnancy loss linked to infectious, metabolic, anatomic or hormonal factors
研究组 & 干预措施
antiphospholipid syndrome patients
Other
干预措施: Diffusion tensor imaging MRI (Procedure)
Control
Other
干预措施: Diffusion tensor imaging MRI (Procedure)
结局指标
主要结局
Mean diffusivity of white matter between groups
时间窗: Day 0
mm2/s
次要结局
- Fractional anisotropy of white matter between groups(Day 0)
- Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies(Day 0)
- Radial diffusivity of white matter between groups(Day 0)
- Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies(Day 0)
- Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies(Day 0)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Obstetric Antiphospholipid Antibody Syndrome : Contribution of the Evaluation of ADAMTS13 Made at the Diagnosis of Pregnancy on Evaluation the Risk of Pre-eclampsiaAntiphospholipid Antibody Syndrome in PregnancyNCT04319341Centre Hospitalier Universitaire de Nīmes513
招募中
不适用
Antiphospholipid Syndrome and Postpartum Pulmonary Artery PressureAntiphospholipid Syndrome in PregnancyPulmonary HypertensionComplicating Pregnancy Pre-EclampsiaNCT05679206Insel Gruppe AG, University Hospital Bern900
撤回
2 期
HYDROxychloroquine in Syndrome Primary AntiPhospholipidAntiphospholipid Syndrome in PregnancyAnticoagulantsNCT04275778Assistance Publique - Hôpitaux de Paris110
已完成
4 期
A Modified Surgical Approach to Women With Obstetric Anal Sphincter TearsObstetric Surgical ProceduresNCT01021722Karolinska University Hospital239
招募中
不适用
MISOPROSTOL FOR THE TREATMENT OF SUSPECTED POSTPARTUM RETAINED PRODUCTS OF CONCEPTIONRetained Products of ConceptionNCT06009679Assuta Ashdod Hospital150