Use of Platelet Indices for Prediction of Recurrent Miscarriage

NCT03710226 | Completed DMC

• 1 other identifier: FMASU 1210/2018
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Miscarriage

Keywords

mean platelet volume; plateletcrit; platelet distribution width

Outcome Measures

Primary Outcomes (3)

• Mean Platelet Volume (MPV)

  it's a measure of the average size of the platelet, expressed in femtolitre (fL)

  1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)

• plateletcrit (PCT)

  it's a measure of total platelet mass, expressed in percentage (%).

  1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)

• Platelet Distribution Width (PDW)

  it's a measure that reflects variation of platelet size distribution, expressed in femtolitre (fL)

  1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)

Study Arms (2)

cases

women with recurrent miscarriage (two or more consecutive miscarriages)

controls

women without recurrent miscarriage and delivered at least once before

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women attending recurrent pregnancy loss clinic in Ain Shams University Maternity Hospital

You may qualify if:

• Women aged 18-49 years.
• Women with history of recurrent miscarriage(two or more consecutive miscarriages)
• Women with history of previous deliveries.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rania Hassan Mostafa: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed k Makled, Phd

  Professor

  STUDY CHAIR

• Wessam M Abuelghar, Phd

  Assistant professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 13, 2018
• First Posted: October 18, 2018
• Study Start: January 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 30, 2019
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

EG (1)