The Role of Prothrombin Gene Polymorphism as a Risk Factor for Recurrent Pregnancy Loss
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ClinicalTrials.gov Identifier: NCT03209063 |
Recruitment Status : Unknown
Verified July 2017 by Ghada Mahran, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
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Condition or disease | Intervention/treatment |
---|---|
Recurrent Pregnancy Loss | Diagnostic Test: polymerase chain reaction |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | The Role of Prothrombin Gene Polymorphism as a Risk Factor for Recurrent Pregnancy Loss |
Estimated Study Start Date : | August 1, 2017 |
Estimated Primary Completion Date : | August 1, 2018 |
Estimated Study Completion Date : | December 30, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Group 1
10 "healthy" controls (18-45 years) with no history of recurrent pregnancy loss and at least one uncomplicated full-term pregnancy.
|
Diagnostic Test: polymerase chain reaction
diagnostic test as Polymerase chain reaction for detection of Prothrombin gene mutation
Other Name: homocysteine assay |
Group 2
45 patients having history of two or more pregnancy losses and no past history of Venous thromboembolism
|
Diagnostic Test: polymerase chain reaction
diagnostic test as Polymerase chain reaction for detection of Prothrombin gene mutation
Other Name: homocysteine assay |
Group 3
45 patients having history of two or more pregnancy losses and past history of Venous thromboembolism
|
Diagnostic Test: polymerase chain reaction
diagnostic test as Polymerase chain reaction for detection of Prothrombin gene mutation
Other Name: homocysteine assay |
- percentage of recurrent pregnancy loss with the presence of prothrombin gene mutation in these women [ Time Frame: 2 days ]using polymerase chain reaction Polymerase chain reaction

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Group 1: 10 "healthy" controls (18-45 years) with no history of recurrent pregnancy loss and at least one uncomplicated full-term pregnancy.
- Group2: 45 patients having history of two or more pregnancy losses and no past history of Venous thromboembolism
- Group 3: 45 patients having history of two or more pregnancy losses and past history of Venous thromboembolism
Exclusion Criteria:
- Age more than 45 years.
- Women with elevated level of thyroid-stimulating hormone or prolactin and uncontrolled diabetes mellitus
- Women with autoimmune disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209063
Contact: Hanan G Abdelazim, prof.doctor | 01227370520 | hanangalal2000@yahoo.com |
Principal Investigator: | Ghada M Mahran, MD | Assiut University, Faculty of medicine |
Publications:
Responsible Party: | Ghada Mahran, principal investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT03209063 History of Changes |
Other Study ID Numbers: |
TROPGP |
First Posted: | July 6, 2017 Key Record Dates |
Last Update Posted: | July 6, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Abortion, Spontaneous Fetal Death Abortion, Habitual Pregnancy Complications Death |
Pathologic Processes Thrombin Hemostatics Coagulants |