NCT07832513尚未招募不适用
A Prospective Multicentre Study to Evaluate Maternal and Perinatal Outcomes in Myeloproliferative Neoplasms: MAPP-MPN Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Proportion of pregnancies resulting in live birth
研究概览
简要总结
This is a study to evaluate pregnancy in patients with myeloproliferative neoplasms. The main endpoint of this study is to determine the number of live births in pregnant MPN patients who are managed by a risk-adapted algorithm
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of chronic phase essential thrombocythemia (ET), polycythemia vera (PV), prefibrotic or overt primary myelofibrosis (PMF), post-ET myelofibrosis (MF), post-PV MF, or myeloproliferative neoplasm (MPN) - unclassifiable according to the 2022 International Consensus Criteria. Patients who have not had a diagnostic bone marrow biopsy may participate if there is a driver mutation and all other diagnostic criteria are met.
- •Patients with a confirmed pregnancy through Beta Human Chorionic Gonadotropin (BHCG) testing of the urine or blood and/or dating ultrasound. Patients may be eligible to participate at any stage of pregnancy.
- •Patients must have the ability to participate in study procedures.
- •Participants must provide consent to participate in this study.
排除标准
- •Patients with a diagnosis of chronic myeloid leukemia, myelodysplastic syndrome (MDS), MDS/MPN overlap syndrome, or other myeloid malignancy.
- •Peripheral blood or marrow blasts >/= 10%.
- •Patients with concurrent disease that in the opinion of the investigator may be adversely impact the safety of the patient or impair assessment of study results, including but not limited to:
- •Uncontrolled autoimmune diseases (e.g., hepatitis, immune thrombocytopenic purpura [ITP], scleroderma, autoimmune arthritis)
- •Active, uncontrolled infection (e.g., HIV, hepatitis B, hepatitis C)
- •Second malignancy requiring concurrent treatment, except basal cell carcinoma or squamous cell carcinoma or cervical carcinoma in situ.
- •Patients requiring a legally authorized representative.
研究组 & 干预措施
Participants with myeloproliferative neoplasms and are pregnant
干预措施: Risk-adapted algorithm (Other)
结局指标
主要结局
Proportion of pregnancies resulting in live birth
时间窗: 3 years
次要结局
- Number of perinatal venous thrombotic events(3 years)
- Number of arterial thromboembolic events(3 years)
- Number of perinatal major bleeding events(3 years)
- Proportion of participant deaths from any cause, starting from the beginning of the pregnancy up until 12 weeks after the pregnancy ends.(3 years)
- Number of hypertensive disorder events of pregnancy at less than 34 weeks(3 years)
- Number of hypertensive disorder events of pregnancy at greater than 34 weeks(3 years)
- Number of participants diagnosed with placental insufficiency(3 years)
研究者
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