Abortion, RecurrentNCT05190796
Platelet Indices and Recurrent Pregnancy Loss
An observational study of Abortion, Recurrent, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate relationship between platelet indices, red blood cell indices and recurrent pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Abortion, Recurrent
- What is being tested?
- platelet indices
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Nov 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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).
- Conditions
- Abortion, Recurrent
- Being tested
- platelet indices
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet indicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| women with history of recurrent pregnancy loss. | 100 women who had history of recurrent pregnancy loss. Receives: 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) Receives: Other: platelet indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Platelet Volume
a measure of the average size of the platelet, expressed in femtolitre (fL)
Measured: 1 day
plateletcrit (PCT)
a measure of total platelet mass, expressed in percentage (%)
Measured: 1 day
Platelet Distribution Width (PDW)
a measure that reflects variation of platelet size distribution, expressed in femtolitre (fL)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, RecurrentStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsibai Anter, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190796
- Sponsor's protocol ID
- 19819OBSGN26
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Platelet Indices and Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05190796
- Acronym / sponsor ID
- 19819OBSGN26
- Conditions
- Abortion, Recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate relationship between platelet indices, red blood cell indices and recurrent pregnancy loss.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with history of recurrent pregnancy loss. | – | Other: platelet indices100 women who had history of recurrent pregnancy loss. |
| women without history of recurrent pregnancy loss. | – | Other: platelet indices50 women who had given birth at term (>37 weeks of gestation) to healthy infants (control group) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet indicesOne 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. | Other | women with history of recurrent pregnancy loss., women without history of recurrent pregnancy loss. |
Primary outcome
Mean Platelet Volume
Time frame: 1 day
a measure of the average size of the platelet, expressed in femtolitre (fL)
plateletcrit (PCT)
Time frame: 1 day
a measure of total platelet mass, expressed in percentage (%)
Platelet Distribution Width (PDW)
Time frame: 1 day
a measure that reflects variation of platelet size distribution, expressed in femtolitre (fL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Recurrent, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Platelet Volume (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.