title: Maintenance treatment of preterm labor with the oxytocin antagonist atosiban. The Atosiban PTL-098 Study Group.
abstract: OBJECTIVE
  Patients admitted with an acute episode of preterm labor who respond to early intravenously administered tocolysis remain at risk of having subsequent episodes of preterm labor and preterm delivery. Several pharmacologic agents have been used in an attempt to reduce subsequent episodes of preterm labor, and all are associated with significant side effects. Atosiban, an oxytocin receptor antagonist, is effective in the treatment of an acute episode of preterm labor. This study was designed to compare the efficacy and safety of atosiban with those of placebo maintenance therapy in women with preterm labor who achieved uterine quiescence with intravenous atosiban.
  
  
  METHODS
  A multicenter, double-blind, placebo-controlled trial was designed for patients in preterm labor who responded to early intravenous treatment with atosiban. Five hundred thirteen patients were randomly assigned to receive maintenance therapy, 252 to receive atosiban, and 251 to receive matching placebo. Maintenance therapy was administered as a continuous subcutaneous infusion, via pump, of 30 microg/min to the end of 36 weeks' gestation. The primary end point was the number of days from the start of maintenance therapy until the first recurrence of labor. A secondary end point was the percentage of patients receiving subsequent intravenous atosiban therapy.
  
  
  RESULTS
  The time (median) from the start of maintenance treatment to the first recurrence of labor was 32.6 days with atosiban and 27.6 days with placebo (P =.02). At least one subsequent intravenous atosiban treatment was needed by 61 atosiban patients (23%) and 77 placebo patients (31%). Except for injection site reactions, adverse event profiles of atosiban and placebo were comparable. There were 4 neonatal deaths reported in the atosiban group and 5 in the placebo group after the start of maintenance therapy. Infant outcomes (including birth weight) were comparable between maintenance and treatment groups.
  
  
  CONCLUSIONS
  Maintenance therapy with the oxytocin receptor antagonist atosiban can prolong uterine quiescence after successful treatment of an acute episode of preterm labor with atosiban. Treatment was well tolerated.
authors.affiliation: Arrowhead Regional Medical Center, Colton, CA 92324, USA.
authors.forename: G J
authors.initials: GJ
authors.lastname: Valenzuela
authors.forename: L
authors.initials: L
authors.lastname: Sanchez-Ramos
authors.forename: R
authors.initials: R
authors.lastname: Romero
authors.forename: H M
authors.initials: HM
authors.lastname: Silver
authors.forename: W D
authors.initials: WD
authors.lastname: Koltun
authors.forename: L
authors.initials: L
authors.lastname: Millar
authors.forename: J
authors.initials: J
authors.lastname: Hobbins
authors.forename: W
authors.initials: W
authors.lastname: Rayburn
authors.forename: G
authors.initials: G
authors.lastname: Shangold
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Smith
authors.forename: G W
authors.initials: GW
authors.lastname: Creasy
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006727:Hormone Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007752:Obstetric Labor, Premature / Q000188:drug therapy*; D010121:Oxytocin / Q000037:antagonists & inhibitors*; D010919:Placebos; D011247:Pregnancy; D013997:Time Factors; D015149:Tocolytic Agents / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014668:Vasotocin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D006727:Hormone Antagonists; D010919:Placebos; D015149:Tocolytic Agents; C047046:atosiban; D010121:Oxytocin; D014668:Vasotocin