title: Paternal therapy with disease modifying drugs in multiple sclerosis and pregnancy outcomes: a prospective observational multicentric study.
abstract: BACKGROUND
  Most of Multiple Sclerosis (MS) patients undergo disease modifying drug (DMD) therapy at childbearing age. The objective of this prospective, collaborative study, was to assess outcomes of pregnancies fathered by MS patients undergoing DMD.
  
  
  METHODS
  Structured interviews on pregnancies fathered by MS patients gathered in the Italian Pregnancy Dataset were collected; pregnancies were divided according to father exposure or unexposure to DMD at time of procreation. Treatment were compared with multivariable logistic and linear models.
  
  
  RESULTS
  Seventy-eight pregnancies fathered by MS patients were tracked. Forty-five patients were taking DMD at time of conception (39 beta-interferons, 6 glatiramer acetate), while 33 pregnancies were unexposed to DMD. Seventy-five pregnancies ended in live-births, 44 in the exposed and 31 in the unexposed group. No significant differences between the two groups were found in the risk of spontaneous abortion or malformations (p > 0.454), mean gestational age (p = 0.513), frequency of cesarean delivery (p = 0.644), birth weight (p = 0.821) and birth length (p = 0.649). In comparison with data of the Italian general population, the proportion of spontaneous abortion and caesarean delivery in exposed pregnancies fell within the estimates, while the proportion of pre-term delivery in the exposed group was higher than expected.
  
  
  CONCLUSIONS
  Our data indicate no association between paternal DMD exposure at time of conception and risk of spontaneous abortion, adverse fetal outcomes and congenital malformations. Further studies clarifying the role of DMD fathers intake prior and during pregnancy are desirable, to supply guidelines for clinical practice.
authors.forename: Chiara
authors.initials: C
authors.lastname: Pecori
authors.forename: Marta
authors.initials: M
authors.lastname: Giannini
authors.forename: Emilio
authors.initials: E
authors.lastname: Portaccio
authors.forename: Angelo
authors.initials: A
authors.lastname: Ghezzi
authors.forename: Bahia
authors.initials: B
authors.lastname: Hakiki
authors.forename: Luisa
authors.initials: L
authors.lastname: Pastò
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Razzolini
authors.forename: Andrea
authors.initials: A
authors.lastname: Sturchio
authors.forename: Laura
authors.initials: L
authors.lastname: De Giglio
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.forename: Damiano
authors.initials: D
authors.lastname: Paolicelli
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Marrosu
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Mancardi
authors.forename: Claudio
authors.initials: C
authors.lastname: Solaro
authors.forename: Rocco
authors.initials: R
authors.lastname: Totaro
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Tola
authors.forename: Giovanna
authors.initials: G
authors.lastname: De Luca
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lugaresi
authors.forename: Lucia
authors.initials: L
authors.lastname: Moiola
authors.forename: Vittorio
authors.initials: V
authors.lastname: Martinelli
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.affiliation: Department of NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134 Florence, Italy. mariapia.amato@unifi.it.
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Amato
mesh_terms: D000022:Abortion, Spontaneous / Q000453:epidemiology; D000328:Adult; D002585:Cesarean Section / Q000706:statistics & numerical data; D005220:Fathers; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016899:Interferon-beta / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D007752:Obstetric Labor, Premature / Q000453:epidemiology; D010455:Peptides / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate; D016899:Interferon-beta