title: The relationship of the factor V Leiden mutation and pregnancy outcomes for mother and fetus.
abstract: OBJECTIVE
  We sought to estimate the frequency of pregnancy-related thromboembolic events among carriers of the factor V Leiden (FVL) mutation without a personal history of thromboembolism, and to evaluate the impact of maternal and fetal FVL mutation carriage or other thrombophilias on the risk of adverse outcomes.
  
  
  METHODS
  Women with a singleton pregnancy and no history of thromboembolism were recruited at 13 clinical centers before 14 weeks of gestation from April 2000 to August 2001. Each was tested for the FVL mutation, as was the resultant conceptus after delivery or after miscarriage, when available. The incidence of thromboembolism (primary outcome), and of other adverse outcomes, was compared between FVL mutation carriers and noncarriers. We also compared adverse outcomes in a secondary nested carrier-control analysis of FVL mutation and other coagulation abnormalities. In this secondary analysis, we defined carriers as women having one or more of the following traits: carrier for FVL mutation, protein C deficiency, protein S deficiency, antithrombin III deficiency, activated protein C resistance, or lupus anticoagulant-positive, heterozygous for prothrombin G20210A or homozygous for the 5,10 methylenetetrahydrofolate reductase mutations. Carriers of the FVL mutation alone (with or without activated protein C resistance) were compared with those having one or more other coagulation abnormalities and with controls with no coagulation abnormality.
  
  
  RESULTS
  One hundred thirty-four FVL mutation carriers were identified among 4,885 gravidas (2.7%), with both FVL mutation status and pregnancy outcomes available. No thromboembolic events occurred among the FVL mutation carriers (0%, 95% confidence interval 0-2.7%). Three pulmonary emboli and one deep venous thrombosis occurred (0.08%, 95% confidence interval 0.02-0.21%), all occurring in FVL mutation noncarriers. In the nested carrier-control analysis (n = 339), no differences in adverse pregnancy outcomes were observed between FVL mutation carriers, carriers of other coagulation disorders, and controls. Maternal FVL mutation carriage was not associated with increased pregnancy loss, preeclampsia, placental abruption, or small for gestational age births. However, fetal FVL mutation carriage was associated with more frequent preeclampsia among African-American (15.0%) and Hispanic (12.5%) women than white women (2.6%, P = .04), adjusted odds ratio 2.4 (95% confidence interval 1.0-5.2, P = .05).
  
  
  CONCLUSIONS
  Among women with no history of thromboembolism, maternal heterozygous carriage of the FVL mutation is associated with a low risk of venous thromboembolism in pregnancy. Neither universal screening for the FVL mutation, nor treatment of low-risk carriers during pregnancy is indicated.
  
  
  METHODS
  II-2.
authors.affiliation: National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Maryland, USA. uvddizon@ihc.com
authors.forename: Donna
authors.initials: D
authors.lastname: Dizon-Townson
authors.forename: Connie
authors.initials: C
authors.lastname: Miller
authors.forename: Baha
authors.initials: B
authors.lastname: Sibai
authors.forename: Catherine Y
authors.initials: CY
authors.lastname: Spong
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Thom
authors.forename: George
authors.initials: G
authors.lastname: Wendel
authors.forename: Katharine
authors.initials: K
authors.lastname: Wenstrom
authors.forename: Philip
authors.initials: P
authors.lastname: Samuels
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Cotroneo
authors.forename: Atef
authors.initials: A
authors.lastname: Moawad
authors.forename: Yoram
authors.initials: Y
authors.lastname: Sorokin
authors.forename: Paul
authors.initials: P
authors.lastname: Meis
authors.forename: Menachem
authors.initials: M
authors.lastname: Miodovnik
authors.forename: Mary J
authors.initials: MJ
authors.lastname: O'Sullivan
authors.forename: Deborah
authors.initials: D
authors.lastname: Conway
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Wapner
authors.forename: Steven G
authors.initials: SG
authors.lastname: Gabbe
mesh_terms: D000328:Adult; D005165:Factor V / Q000235:genetics*; D005260:Female; D006801:Humans; D017354:Point Mutation; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000453:epidemiology* / Q000503:physiopathology; D011256:Pregnancy Outcome / Q000453:epidemiology* / Q000235:genetics*; D011446:Prospective Studies; D013923:Thromboembolism / Q000453:epidemiology*; D014481:United States / Q000453:epidemiology
chemical_list: C095381:factor V Leiden; D005165:Factor V