title: Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial.
abstract: BACKGROUND
  Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.
  
  
  METHODS
  The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.
  
  
  CONCLUSIONS
  This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.
  
  
  BACKGROUND
  Dutch Trial Register: NTR3110.
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands. m.a.verschoor@amc.uva.nl
authors: Marianne A C
authors: MA
authors: Verschoor
authors: Marike
authors: M
authors: Lemmers
authors: Patrick M
authors: PM
authors: Bossuyt
authors: Giuseppe C M
authors: GC
authors: Graziosi
authors: Petra J
authors: PJ
authors: Hajenius
authors: Dave J
authors: DJ
authors: Hendriks
authors: Marcel A H
authors: MA
authors: van Hooff
authors: Hannah S
authors: HS
authors: van Meurs
authors: Brent C
authors: BC
authors: Opmeer
authors: Maurits W
authors: MW
authors: van Tulder
authors: Liesanne
authors: L
authors: Bouwma
authors: Ruby
authors: R
authors: Catshoek
authors: Peggy
authors: P
authors: Geomini
authors: Ellen R
authors: ER
authors: Klinkert
authors: Josje
authors: J
authors: Langenveld
authors: Theodoor E
authors: TE
authors: Nieboer
authors: J Marinus
authors: JM
authors: van der Ploeg
authors: Celine M
authors: CM
authors: Radder
authors: Taeke
authors: T
authors: Spinder
authors: Lucy F
authors: LF
authors: van der Voet
authors: Ben Willem J
authors: BW
authors: Mol
authors: Judith A F
authors: JA
authors: Huirne
authors: Willem M
authors: WM
authors: Ankum
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000627:therapeutic use; D000027:Abortion, Incomplete / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D000022:Abortion, Spontaneous / Q000188:drug therapy; D000328:Adult; D003362:Cost-Benefit Analysis; D004107:Dilatation and Curettage / Q000191:economics*; D005260:Female; D006801:Humans; D016595:Misoprostol / Q000627:therapeutic use; D011247:Pregnancy; D018873:Pregnancy Rate; D011261:Pregnancy Trimester, First; D011788:Quality of Life; D012086:Reoperation; D012107:Research Design; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging* / Q000601:surgery; D057832:Watchful Waiting / Q000191:economics*; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol
references: N Engl J Med. 2005 Aug 25;353(8):761-9
references: 16120856
references: Hum Reprod. 2004 Jul;19(7):1655-8
references: 15178656
references: Hum Reprod. 2004 Aug;19(8):1894-9
references: 15192065
references: J Clin Epidemiol. 2004 Feb;57(2):167-73
references: 15125626
references: Int J Gynaecol Obstet. 2004 Sep;86(3):337-46
references: 15325850
references: Cochrane Database Syst Rev. 2002;(4):CD003037
references: 12519584
references: Hum Reprod. 2005 Apr;20(4):1067-71
references: 15618248
references: J Obstet Gynaecol. 2007 Apr;27(3):283-6
references: 17464813
references: Fertil Steril. 2012 Feb;97(2):355-60
references: 22192348
references: BJOG. 2009 Jun;116(7):984-90
references: 19385962
references: Br J Hosp Med (Lond). 2008 Jul;69(7):380-3
references: 18833966
references: Acta Obstet Gynecol Scand. 2010 Sep;89(9):1210-3
references: 20804347
references: Hum Reprod. 2002 Jun;17(6):1638-42
references: 12042291
references: Hum Reprod. 2004 Feb;19(2):266-71
references: 14747165
references: Int J Technol Assess Health Care. 1996 Summer;12(3):405-15
references: 8840661
references: Hum Reprod. 2005 Oct;20(10):2873-8
references: 15979988
references: Fertil Steril. 2009 Jan;91(1):28-31
references: 18295212
references: BMJ. 2006 May 27;332(7552):1235-40
references: 16707509
references: Int J Gynaecol Obstet. 2004 Jul;86(1):22-6
references: 15207665