title: Medical treatment of ectopic pregnancies: a randomized clinical trial comparing methotrexate-mifepristone and methotrexate-placebo.
abstract: BACKGROUND
  Medical treatment of ectopic pregnancies is common. To increase the efficacy of methotrexate, the association of mifepristone has been proposed.
  
  
  METHODS
  We performed a large prospective multicentre double-blind sequential randomized trial in order to compare the efficacy of methotrexate and mifepristone (600 mg given orally) versus methotrexate and placebo.
  
  
  RESULTS
  A total of 212 ectopic pregnancies was randomized. There was no significant difference in the initial characteristics between the two groups. There was no significant difference in the success rate of medical treatment between the methotrexate-mifepristone (n = 113) and the methotrexate-placebo group (n = 99): 79.6% (90/113) versus 74.2% (72/97) respectively, RR (95% CI): 1.07 (0.92-1.25), P = 0.41, non-significant. However, there was a quantitative interaction between progesterone level and effect of treatment: when progesterone level was >/=10 ng/l, the efficacy of the combination of mifepristone and methotrexate was significantly higher than the combination of methotrexate and placebo, with an 83.3% success rate (15/18) versus 38.5% (5/13) respectively.
  
  
  CONCLUSIONS
  Our study failed to demonstrate any benefit of the addition of mifepristone to methotrexate. By contrast, the quantitative interaction between treatment effect and baseline serum progesterone suggested that this combination could be limited to ectopic pregnancies associated with high serum progesterone concentrations.
authors.affiliation: Department of Obstetrics and Gynecology, Poissy-Saint Germain Hospital, University Versailles-St Quentin, France. prozenberg@chi-poissy-st-germain.fr
authors.forename: Patrick
authors.initials: P
authors.lastname: Rozenberg
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Eric
authors.initials: E
authors.lastname: Camus
authors.forename: Renaud
authors.initials: R
authors.lastname: de Tayrac
authors.forename: Olivier
authors.initials: O
authors.lastname: Garbin
authors.forename: Loïc
authors.initials: L
authors.lastname: de Poncheville
authors.forename: Jerry
authors.initials: J
authors.lastname: Coiffic
authors.forename: Jean Philippe
authors.initials: JP
authors.lastname: Lucot
authors.forename: Françoise
authors.initials: F
authors.lastname: Le Goueff
authors.forename: Didier
authors.initials: D
authors.lastname: Tardif
authors.forename: Claude
authors.initials: C
authors.lastname: Allouche
authors.forename: Hervé
authors.initials: H
authors.lastname: Fernandez
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000021:Abortifacient Agents, Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D015735:Mifepristone / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011247:Pregnancy; D011271:Pregnancy, Ectopic / Q000097:blood / Q000188:drug therapy*; D011374:Progesterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D010919:Placebos; D015735:Mifepristone; D011374:Progesterone; D008727:Methotrexate