The Role of Prothrombin Gene Polymorphism as a Risk Factor for Recurrent Pregnancy Loss

• ClinicalTrials.gov Identifier: NCT03209063
• Recruitment Status: Unknown
• First Posted: July 6, 2017
• Last Update Posted: July 6, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ghada Mahran, Assiut University

Study Description

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 .

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Assiut University

Investigators

• Principal Investigator: Ghada M Mahran, MD; Assiut University, Faculty of medicine

More Information

Publications:

Farahmand K, Totonchi M, Hashemi M, Reyhani Sabet F, Kalantari H, Gourabi H, Mohseni Meybodi A. Thrombophilic genes alterations as risk factor for recurrent pregnancy loss. J Matern Fetal Neonatal Med. 2016;29(8):1269-73. doi: 10.3109/14767058.2015.1044431. Epub 2015 Jul 2.

• 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
• 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

Additional relevant MeSH terms:

Abortion, Spontaneous; Fetal Death; Abortion, Habitual; Pregnancy Complications; Death; Pathologic Processes; Thrombin; Hemostatics; Coagulants