- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190796
Platelet Indices and Recurrent Pregnancy Loss
December 29, 2021 updated by: Mohamed Elsibai Anter, Menoufia University
Relationship Between Platelet Indices and Recurrent Pregnancy Loss
The aim of this study was to evaluate relationship between platelet indices, red blood cell indices and recurrent pregnancy loss.
Study Overview
Detailed Description
Recurrent pregnancy loss is defined as three or more consecutive pregnancy losses at or less than 20 weeks of gestation or with a fetal weight less than 500 gram.
The American society for reproductive medicine (2008) proposed that recurrent pregnancy loss is defined as two or more failed clinical pregnancies confirmed by either sonographic or histopathological examination.The etiology of recurrent pregnancy loss is multifactorial and include uterine anomalies, endocrinological disorders, immunological causes, infection, chromosomal abnormalities and maternal autoimmune diseases.
However, the underlying cause cannot be clarified in 50-60% of all recurrent pregnancy miscarriages.Accumulating evidence supports the concept that abnormalities of blood coagulation, generically defined as the presence of a prothrombotic state (congenital or acquired), plays an important role in adverse pregnancy outcome and is the basis of 40-70% of cases of recurrent abortions or unexplained sterility.
In addition to development of many pregnancy complications such as preeclampsia, intrauterine growth restriction, preterm labor, preterm pre-labor rupture of membranes and fetal demise, recognize the same mechanism .Pregnancy causes many alterations in hemostatic balance that leading to a tendency towards thrombophilia.
Such a tendency is considered as a mechanism that compensates for the hemostatic challenge of delivery.
Thrombophilia in pregnancy is due to the increase in several clotting factors, including factor I, factor VII, factor VIII and von Willebrand.
Moreover other markers reflecting hypercoagulability (such as D-dimer and/or prothrombin fragment) are increased during pregnancy .Red cell distribution width is a red cell parameter that measures the variability of red cell volume/size (anisocytosis).
Red cell distribution width can be reported statistically as RDW-CV (coefficient of variation) or RDW-SD (standard deviation).
RDW-SD is an actual measurement of the width of the erythrocyte distribution curve (measured at a relative height of 20% above the baseline).Reference range: 39-46fL .RDW-CV is calculated from standard deviation and MCV.
RDW-CV: 1SD/MCV x 100, reference Range: 11.6-14.6%
(Cholada and Eris, 2015), (Curry and Staros, 2015).
11.6-14.6%
platelet distribution width is an indicator of variation in the size of platelet which may be a sign of activation of platelets.
PDW is a simple, practical and more specific marker of platelet activation.
An increased PDW is an indication for the anisocytosis of platelets.
Standard PDW ranges from 9 to 14 fL (Aynioglu et al., 2014).
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Menoufia
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Shibīn Al Kawm, Menoufia, Egypt, 11111
- Menoufia University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
This study included 150 subjects attending outpatient clinic of menoufia university hospital and were divided into two groups:
- Group A: 100 women who had history of recurrent pregnancy loss.
- Group B: 50 women who had given birth at term (>37 weeks of gestation) to healthy infants (control group).
Description
Inclusion Criteria:
- patients with Recurrent miscarriage is defined as three or more consecutive pregnancy losses at or less than 20 weeks of gestation or with a fetal weight less than 500 grams
Exclusion Criteria:
- A woman who had experienced recurrent pregnancy loss due to uterine anomalies, diabetes mellitus and thyroid disease.
- Hypertensive women.
- Patients with coagulation defects.
- History of deep vein thrombosis or pulmonary thromboembolism.
- Use of medications affecting platelet functions such as aspirin, nonsteroidal anti-inflammatory drugs, oral contraceptives, hormonal treatments, anti-platelet, and anticoagulant drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
women with history of recurrent pregnancy loss.
100 women who had history of recurrent pregnancy loss.
|
One sample of 20 mL venous blood was drawn by standard phlebotomy from all of the participants.
This sample was kept for the evaluation of hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), erythrocyte count, leukocyte count, platelet count, platelet distribution width (PDW), MPV and plateletcrit by means of an automated commercial counter (Coulter counter, Max Instruments Laboratory).
After this venous blood sample was conveyed into a sodium citrate tube, it was transported in a temperature-controlled container and collected in plastic provettes (Falcon blue cap) containing 3 mL of 3.8% sodium citrate dihydrate and 136 mM glucosium.
Then the samples were sent to the laboratory.
|
women without history of recurrent pregnancy loss.
50 women who had given birth at term (>37 weeks of gestation) to healthy infants (control group)
|
One sample of 20 mL venous blood was drawn by standard phlebotomy from all of the participants.
This sample was kept for the evaluation of hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), erythrocyte count, leukocyte count, platelet count, platelet distribution width (PDW), MPV and plateletcrit by means of an automated commercial counter (Coulter counter, Max Instruments Laboratory).
After this venous blood sample was conveyed into a sodium citrate tube, it was transported in a temperature-controlled container and collected in plastic provettes (Falcon blue cap) containing 3 mL of 3.8% sodium citrate dihydrate and 136 mM glucosium.
Then the samples were sent to the laboratory.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Platelet Volume
Time Frame: 1 day
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a measure of the average size of the platelet, expressed in femtolitre (fL)
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1 day
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plateletcrit (PCT)
Time Frame: 1 day
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a measure of total platelet mass, expressed in percentage (%)
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1 day
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Platelet Distribution Width (PDW)
Time Frame: 1 day
|
a measure that reflects variation of platelet size distribution, expressed in femtolitre (fL)
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2020
Primary Completion (ACTUAL)
September 1, 2021
Study Completion (ACTUAL)
November 1, 2021
Study Registration Dates
First Submitted
December 29, 2021
First Submitted That Met QC Criteria
December 29, 2021
First Posted (ACTUAL)
January 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2022
Last Update Submitted That Met QC Criteria
December 29, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19819OBSGN26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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