title: Defining safe criteria to diagnose miscarriage: prospective observational multicentre study.
abstract: OBJECTIVE
  To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.)
  
  
  METHODS
  Prospective multicentre observational trial.
  
  
  METHODS
  Seven hospital based early pregnancy assessment units in the United Kingdom.
  
  
  METHODS
  2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm.
  
  
  METHODS
  Mean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks' gestation.
  
  
  RESULTS
  The following indicated a miscarriage at initial scan: mean gestational sac diameter ≥ 25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ≥ 7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ≥ 18 mm for gestational sacs without an embryo presenting after 70 days' gestation (907/907 specificity: 100%, 99.6% to 100%), embryo with crown-rump length ≥ 3 mm without visible heart activity presenting after 70 days' gestation (87/87 specificity: 100%, 95.8% to 100%). The following were indicative of miscarriage at a repeat scan: initial scan and repeat scan after seven days or more showing an embryo without visible heart activity (103/103 specificity: 100%, 96.5% to 100%), pregnancies without an embryo and mean gestational sac diameter <12 mm where the mean diameter has not doubled after 14 days or more (478/478 specificity: 100%, 99.2% to 100%), pregnancies without an embryo and mean gestational sac diameter ≥ 12 mm showing no embryo heartbeat after seven days or more (150/150 specificity: 100%, 97.6% to 100%).
  
  
  CONCLUSIONS
  Recently changed cut-off values of gestational sac and embryo size defining miscarriage are appropriate and not too conservative but do not take into account gestational age. Guidance on timing between scans and expected findings on repeat scans are still too liberal. Protocols for miscarriage diagnosis should be reviewed to account for this evidence to avoid misdiagnosis and the risk of terminating viable pregnancies.
authors.affiliation: Queen Charlotte's and Chelsea Hospital, Imperial College, London W12 0HS, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Preisler
authors.affiliation: Early Pregnancy and Acute Gynaecology Unit, St Thomas' Hospital, London, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Kopeika
authors.affiliation: Queen Charlotte's and Chelsea Hospital, Imperial College, London W12 0HS, UK St Mary's Hospital, Imperial College NHS Trust, London, UK.
authors.forename: Laure
authors.initials: L
authors.lastname: Ismail
authors.affiliation: Chelsea and Westminster Hospital, London, UK.
authors.forename: Veluppillai
authors.initials: V
authors.lastname: Vathanan
authors.affiliation: Queen Charlotte's and Chelsea Hospital, Imperial College, London W12 0HS, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Farren
authors.affiliation: Queen Charlotte's and Chelsea Hospital, Imperial College, London W12 0HS, UK.
authors.forename: Yazan
authors.initials: Y
authors.lastname: Abdallah
authors.affiliation: Northwick Park Hospital, Harrow, Middlesex, UK.
authors.forename: Parijat
authors.initials: P
authors.lastname: Battacharjee
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: Van Holsbeke
authors.affiliation: Chelsea and Westminster Hospital, London, UK.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Bottomley
authors.affiliation: St Mary's Hospital, Imperial College NHS Trust, London, UK.
authors.forename: Deborah
authors.initials: D
authors.lastname: Gould
authors.affiliation: Princess Anne Hospital, Southampton, Hampshire UK.
authors.forename: Susanne
authors.initials: S
authors.lastname: Johnson
authors.affiliation: Queen Charlotte's and Chelsea Hospital, Imperial College, London W12 0HS, UK.
authors.forename: Catriona
authors.initials: C
authors.lastname: Stalder
authors.affiliation: Department of Development and Regeneration, KU Leuven, Belgium.
authors.forename: Ben
authors.initials: B
authors.lastname: Van Calster
authors.affiliation: Early Pregnancy and Acute Gynaecology Unit, St Thomas' Hospital, London, UK.
authors.forename: Judith
authors.initials: J
authors.lastname: Hamilton
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium Department of Development and Regeneration, KU Leuven, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: Timmerman
authors.affiliation: Queen Charlotte's and Chelsea Hospital, Imperial College, London W12 0HS, UK Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium Department of Development and Regeneration, KU Leuven, Belgium tbourne@imperial.ac.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Bourne
mesh_terms: D000022:Abortion, Spontaneous / Q000000981:diagnostic imaging* / Q000473:pathology; D018568:Crown-Rump Length; D005260:Female; D005313:Fetal Death; D005865:Gestational Age; D058746:Gestational Sac / Q000000981:diagnostic imaging* / Q000473:pathology; D006801:Humans; D061214:Patient Safety; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D013997:Time Factors; D016216:Ultrasonography, Prenatal