Use of Platelet Indices for Prediction of Recurrent Miscarriage
Condition: Recurrent Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      -  Study population:

        -  Sample size: This study will be conducted on (70) women attending outpatient clinic
           divided into two groups:

             -  1st Group (35): women with history of recurrent miscarriage (two or more
                consecutive miscarriages)

             -  2nd Group (35): women without history of recurrent miscarriage and delivered at
                least once before.

        -  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)

        -  Methods:

        -  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.

        -  Informed Consent: All participants will give their informed consent prior to enrollment

        -  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

        -  Transvaginal ultrasound: to exclude any uterine anomalies.

        -  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.

             -  All other enrolled women will be tested by CBC by XN-1000(SA-01) machine.

             -  The blood sample will be preserved by EDTA and will be processed within maximum 2
                hours..

        -  Data collection & recording: Data of each patient will be recorded in a Case Record Form
           (CRF)

        -  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:

      1. Informed Consent Forms: Before being admitted to the study, the patient must consent to
      participate after the nature, scope, and steps of the study have been explained in a form
      understandable to her.

      2- Confidentiality: Only the patient number and patient initials will be recorded in the CRF.
      The investigator will maintain a personal patient identification list (patient numbers with
      the corresponding patient names) to enable records to be identified.

      3- Protocol approval: Before the beginning of the study and in accordance with the local
      regulation followed, the protocol and all corresponding documents will be declared for
      ethical and research approval by the council of obstetrics and gynaecology department, Ain
      Shams University; according to the WMA Declaration of Helsinki
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        women attending recurrent pregnancy loss clinic in Ain Shams University Maternity Hospital
      
Keywords: mean platelet volume; plateletcrit; platelet distribution width