Recurrent MiscarriageNCT03710226
Use of Platelet Indices for Prediction of Recurrent Miscarriage
An observational study of Recurrent Miscarriage, run by Rania Hassan Mostafa at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Oct 2019
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: women attending recurrent pregnancy loss clinic in Ain Shams University Maternity Hospital
Who may be able to join
- Women aged 18-49 years.
- Women with history of recurrent miscarriage(two or more consecutive miscarriages)
- Women with history of previous deliveries.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There an Association Between Platelet Indices and Recurrent Miscarriage?
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.
Read the 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:
- 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
- Conditions
- Recurrent Miscarriage
- Keywords
- mean platelet volume, plateletcrit, platelet distribution width
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cases | women with recurrent miscarriage (two or more consecutive miscarriages) | |
| controls | women without recurrent miscarriage and delivered at least once before |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Platelet Volume (MPV)
it's a measure of the average size of the platelet, expressed in femtolitre (fL)
Measured: 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 (%).
Measured: 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)
Measured: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jan 2019
- Primary completion30 Aug 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Hassan Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Hassan Mostafa, Ain Shams Maternity Hospital
- Investigators
- Ahmed k Makled, Phd, Study chair, ProfessorWessam M Abuelghar, Phd, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710226
- Sponsor's protocol ID
- FMASU 1210/2018
- Status last verified
- Jan 2021
- First submitted
- 13 Oct 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Association Between Platelet Indices and Recurrent Miscarriage?
- ClinicalTrials.gov ID
- NCT03710226
- Acronym / sponsor ID
- FMASU 1210/2018
- Conditions
- Recurrent Miscarriage
- Keywords
- mean platelet volume, plateletcrit, platelet distribution width
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Rania Hassan MostafaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 Oct 2018 (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.
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:
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –women with recurrent miscarriage (two or more consecutive miscarriages) |
| controls | – | –women without recurrent miscarriage and delivered at least once before |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women attending recurrent pregnancy loss clinic in Ain Shams University Maternity Hospital
Key inclusion criteria (3 listed)
- Women aged 18-49 years.
- Women with history of recurrent miscarriage(two or more consecutive miscarriages)
- Women with history of previous deliveries.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Platelet Volume (MPV)
Time frame: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
it's a measure of the average size of the platelet, expressed in femtolitre (fL)
plateletcrit (PCT)
Time frame: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
it's a measure of total platelet mass, expressed in percentage (%).
Platelet Distribution Width (PDW)
Time frame: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)
it's 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 2021.
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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.
Ahmed k Makled, Phd study chair
Professor
Wessam M Abuelghar, Phd study director
Assistant professor
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 Recurrent Miscarriage, run by Rania Hassan Mostafa 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 3 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 2021. 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 (MPV) (time frame: 1 day (measured once the participant is enrolled in the study & meets the eligibility criteria)). 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 2021.