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Figure B. PRISMA diagram





                      Articles identified
                                          Articles identified
                       through database                       Articles nominated
                                          through search of
                        searching after                       by TEP members
                                          grey literature
                          duplicates                               (n=5)
                                               (n=94)
                       removed (n=255)

                                                                                    Artcles
                                     Total number of articles (n=431)                                    FDA drug safety
                                                                                   unavailable
                                                                                                         communication
                                                                                     (n=4)
         Identification









                Articles identified      Articles screened at             Articles excluded
                 from reviews/             Level 1(n=427)                     (n=215)
               commentaries/letters
               and reference lists of                               Full text articles excluded, with reasons
         Screening  (n=77)                                          (n=197)
                included studies
                                                                    61: SQ tertubaline pump was not given as
                                                                       maintenance tocolytic therapy in at least one
                                                                       pump
                                                                    51: Review article, letter to editor, commentary,
                                                                       or newspaper article
                                                                    25: Study of maternal/neonatal outcomes or
                                         Full text assessed for
                                                                       harms with no comparison group (including
                                      eligibility at Levels 2 and 3    studies where women served as their own
                                              (n=212)                  controls)
                                                                    18: Single or multiple (individual) case report
                                                                    13: Miscellaneous (no patient data, clearly not
         Eligibility                                                12: Non-English abstract or full-text/insufficient
                                                                       relevant to the pump, betamimetic treatment
                                                                       not specified)
                                                                       information provided in abstract (full-text not
                                                                       Full-text unavailable
                                                                    7:  in Englsih)
                                                                    4:  Did not include women with arrested preterm
                                           Included studies            labor
                                               (n=15)               3:  Did not assess one of the specified outcomes
                                                                    2:  Companion article with no additional data
                                                                    1:  Study design did not allow for evaluation of
                                                                       SQ terbutaline pump as the sole maintenance
                                                                       tocolytic therapy
         Included                                                                                        FDA summary


                                   Independent
                                     studies          Companion                                             of post-
                                                        article
                                     (n=14)             (n=1)                                            marketing data




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