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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
Sponsor:
Information provided by (Responsible Party):
Ghada Mahran, Assiut University

Brief Summary:
Recurrent miscarriage is a pregnancy loss before 20 weeks of gestation. The recurrent pregnancy loss usually occurring in the first trimester of gestation and its rate is quite high (15-20% even in full reproductive period) . In 2012, the American Society for Reproductive Medicine Practice Committee issued a statement that defined recurrent pregnancy loss as a disease distinct from infertility defined by two or more failed consecutive pregnancies.

Condition or disease Intervention/treatment
Recurrent Pregnancy Loss Diagnostic Test: polymerase chain reaction

Detailed Description:
Recurrent miscarriage is a pregnancy loss before 20 weeks of gestation. The recurrent pregnancy loss usually occurring in the first trimester of gestation and its rate is quite high (15-20% even in full reproductive period) . In 2012, the American Society for Reproductive Medicine Practice Committee issued a statement that defined recurrent pregnancy loss as a disease distinct from infertility defined by two or more failed consecutive pregnancies. Thrombophilia is the tendency to develop thromboses due to inherited defects in the coagulation system. Thrombophilia was identified as a major cause of recurrent pregnancy loss , Because pregnancy is a hypercoagulable state, thromboembolism is the leading cause of antepartum and postpartum maternal mortality .The four most common genetic markers for thrombophilia are; prothrombin gene mutation(FII, G20210A), methylene tetra hydrofolate reductase mutations (MTHFR and A1298C), factor V Leiden (FVL, G1691A) , and plasminogen activator inhibitor 1 (PAI-1) . Prothrombin G20210A refers to a human gene mutation that increases the risk of blood clots.The variant causes elevated plasma prothrombin levels (hyperprothrombinemia), Prothrombin is the precursor to thrombin, which plays a key role in causing blood to clot (blood coagulation).Prothrombin G20210A can thus contribute to a state of hypercoagulability . Methylene tetra hydrofolate reductase (MTHFR) is the rate-limiting enzyme in the methyl cycle, and it is encoded by the Methylene tetra hydrofolate reductase gene. It was thought that deficient Methylene tetra hydrofolate reductase, by causing elevated homocysteine levels, led to an increased risk of venous thrombosis, coronary heart disease, and recurrent pregnancy loss .

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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
Study Population
The study will be conducted at Clinical Pathology Department,Assiut University Hospital, Faculty of Medicine, Assiut University
Criteria

Inclusion Criteria:

  1. Group 1: 10 "healthy" controls (18-45 years) with no history of recurrent pregnancy loss and at least one uncomplicated full-term pregnancy.
  2. Group2: 45 patients having history of two or more pregnancy losses and no past history of Venous thromboembolism
  3. Group 3: 45 patients having history of two or more pregnancy losses and past history of Venous thromboembolism

Exclusion Criteria:

  1. Age more than 45 years.
  2. Women with elevated level of thyroid-stimulating hormone or prolactin and uncontrolled diabetes mellitus
  3. Women with autoimmune disorders

Information from the National Library of Medicine

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


Contacts
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Contact: Hanan G Abdelazim, prof.doctor 01227370520 hanangalal2000@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ghada M Mahran, MD Assiut University, Faculty of medicine

Publications:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Abortion, Habitual
Pregnancy Complications
Death
Pathologic Processes
Thrombin
Hemostatics
Coagulants