Is There an Association Between Platelet Indices and Recurrent Miscarriage?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean Platelet Volume (MPV)
研究概览
简要总结
Platelet indices might be a marker for platelet activation, and thus could predict thrombosis. This might be the cause in some cases of recurrent miscarriage. This study aims to evaluate the use of platelet indices -as a simple test- to predict recurrent miscarriage.
详细描述
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Study population:
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Sample size: This study will be conducted on (70) women attending outpatient clinic divided into two groups:
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1st Group (35): women with history of recurrent miscarriage (two or more consecutive miscarriages)
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2nd Group (35): women without history of recurrent miscarriage and delivered at least once before.
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Sample size justification: The means of the platelet indices were used to calculate the sample size. Group sample sizes of 35 per group achieve 80% power to reject the null hypothesis of zero effect size when the population effect size is 0.70 (moderate to large) and the significance level (alpha) is 0.050 using a two-sided two-sample equal-variance t-test. (Machin et al., 1997)
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Methods:
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Enrollment: Women will be enrolled from the outpatient clinic and recurrent pregnancy loss outpatient clinic in Ain shams maternity hospital. 70 women will be enrolled from each clinic.
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Informed Consent: All participants will give their informed consent prior to enrollment
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Detailed history and general examination: To exclude obese women (BMI >30%), women with known uterine anomalies, endocrinological diseases or immunological disorders and women on anticoagulants or antiplatelet medications
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Transvaginal ultrasound: to exclude any uterine anomalies.
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Laboratory blood sampling: For testing of (TSH, HbA1C, Anticardiolipin antibody (IgG, IgM), lupus anticoagulant antibodies and Anti-β2 glycoprotein I ) in women with history of recurrent miscarriage and excluded if positive.
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All other enrolled women will be tested by CBC by XN-1000(SA-01) machine.
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The blood sample will be preserved by EDTA and will be processed within maximum 2 hours..
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Data collection & recording: Data of each patient will be recorded in a Case Record Form (CRF)
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Statistics:
Descriptive statistics for measured variables will be expressed as range, mean and standard deviation (for metric data); range, median and interquartile range (for discrete data); and number and proportions (for categorical data the platelet indices in each clinic will be compared using the t-test A P-value of 0.05 or less will be considered statistically significant.
• Ethical considerations:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-49 years.
- •Women with history of recurrent miscarriage(two or more consecutive miscarriages)
- •Women with history of previous deliveries.
排除标准
- •Pregnant women
- •Women with medical disease (e.g. DM, thyroid disorders, hypertension, systemic lupus erythematosus, antiphospholipid antibody syndrome).
- •Women with known uterine anomalies.
- •Obesity (BMI >30%).
- •Women on anticoagulant medications or antiplatelet medications.
结局指标
主要结局
Mean Platelet Volume (MPV)
时间窗: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
it's a measure of the average size of the platelet, expressed in femtolitre (fL)
Platelet Distribution Width (PDW)
时间窗: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
it's a measure that reflects variation of platelet size distribution, expressed in femtolitre (fL)
plateletcrit (PCT)
时间窗: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
it's a measure of total platelet mass, expressed in percentage (%).
次要结局
未报告次要终点
研究者
Rania Hassan Mostafa
Lecturer
Ain Shams Maternity Hospital