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CompletedNCT05190796Updated Jan 13, 2022

Platelet Indices and Recurrent Pregnancy Loss

An observational study in Abortion, Recurrent, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Menoufia University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 40 Years
Sex
Female
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Study summary

The aim of this study was to evaluate relationship between platelet indices, red blood cell indices and recurrent pregnancy loss.

Read the 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).

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Conditions studied

  • Abortion, Recurrent
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In context

Abortion, Habitual

137 studies on the registry are indexed under Abortion, Habitual; 23 are open to participants now.

This study's enrollment of 150 is close to the median of 147 across 60 observational studies indexed under Abortion, Habitual.

Browse Abortion, Habitual studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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).

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • women with history of recurrent pregnancy loss.

    100 women who had history of recurrent pregnancy loss.

    Other: platelet indices

  • women without history of recurrent pregnancy loss.

    50 women who had given birth at term (\>37 weeks of gestation) to healthy infants (control group)

    Other: platelet indices

Interventions

  • Otherplatelet indices

    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.

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What researchers measure

Primary outcomes

  1. Mean Platelet Volume

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

    Time frame: 1 day

  2. plateletcrit (PCT)

    a measure of total platelet mass, expressed in percentage (%)

    Time frame: 1 day

  3. Platelet Distribution Width (PDW)

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

    Time frame: 1 day

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Study locations

1 site
  • Menoufia University hospital
    Shibīn Al Kawm, Menoufia 11111, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05190796
Lead sponsor
Menoufia University
Responsible party
Mohamed Elsibai Anter (Assistant professor of obstetrics and gynecology, Menoufia University) — Principal investigator
First posted
Jan 13, 2022
Start date
Sep 1, 2020
Primary completion
Sep 1, 2021
Completion
Nov 1, 2021
Last update
Jan 13, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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