Document Detail

Limitations of current definitions of miscarriage using mean gestational sac diameter and crown-rump length measurements: a multicenter observational study.
MedLine Citation:
PMID:  21997898     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: There is significant variation in cut-off values for mean gestational sac diameter (MSD) and embryo crown-rump length (CRL) used to define miscarriage, values suggested in the literature ranging from 13 to 25 mm for MSD and from 3 to 8 mm for CRL. We aimed to define the false-positive rate (FPR) for the diagnosis of miscarriage associated with different CRL and MSD measurements with or without a yolk sac in a large study population of patients attending early pregnancy clinics. We also aimed to define cut-off values for CRL and MSD that, on the basis of a single measurement, can definitively diagnose a miscarriage and so exclude possible inadvertent termination of pregnancy.
METHODS: This was an observational cross-sectional study. Data were collected prospectively according to a predefined protocol. Intrauterine pregnancy of uncertain viability (IPUV) was defined as an empty gestational sac or sac with a yolk sac but no embryo seen with MSD < 20 or < 30 mm or an embryo with an absent heartbeat and CRL < 6 mm or < 8 mm. We recruited to the study 1060 consecutive women with IPUV. The endpoint was presence or absence of a viable pregnancy at the time of first-trimester screening ultrasonography between 11 and 14 weeks. The sensitivity, specificity, positive and negative predictive values were calculated for potential cut-off values to define miscarriage from MSD 8 to 30 mm with or without a yolk sac and from CRL 3 to 8 mm.
RESULTS: Of the 1060 women with a diagnosis of IPUV, 473 remained viable and 587 were non-viable by the time of the 11-14-week scan. In the absence of both embryo and yolk sac, the FPR for miscarriage was 4.4% when an MSD cut-off of 16 mm was used and 0.5% for a cut-off of 20 mm. There were no false-positive test results for miscarriage when a cut-off of MSD ≥ 21 mm was used. If a yolk sac was present but an embryo was not, the FPR for miscarriage was 2.6% for an MSD cut-off of 16 mm and 0.4% for a cut-off of 20 mm, with no false-positive results when a cut-off of MSD ≥ 21 mm was used. When an embryo was visible with an absent heartbeat, using a CRL cut-off of 4 mm the FPR for miscarriage was 8.3%, and for a CRL cut-off of 5 mm it was also 8.3%. There were no false-positive results using a CRL cut-off of ≥ 5.3 mm.
CONCLUSIONS: These data show that some current definitions used to diagnose miscarriage are potentially unsafe. Current national guidelines should be reviewed to avoid inadvertent termination of wanted pregnancies. An MSD cut-off of > 25 mm and a CRL cut-off of > 7 mm could be introduced to minimize the risk of a false-positive diagnosis of miscarriage.
Y Abdallah; A Daemen; E Kirk; A Pexsters; O Naji; C Stalder; D Gould; S Ahmed; S Guha; S Syed; C Bottomley; D Timmerman; T Bourne
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2011-10-13
Journal Detail:
Title:  Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology     Volume:  38     ISSN:  1469-0705     ISO Abbreviation:  Ultrasound Obstet Gynecol     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-10-26     Completed Date:  2012-01-13     Revised Date:  2012-06-05    
Medline Journal Info:
Nlm Unique ID:  9108340     Medline TA:  Ultrasound Obstet Gynecol     Country:  England    
Other Details:
Languages:  eng     Pagination:  497-502     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.
Institute of Reproductive and Developmental Biology (IRDB), Imperial College London, London, UK.
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MeSH Terms
Abortion, Spontaneous / classification,  ultrasonography*
Cross-Sectional Studies
Crown-Rump Length*
False Positive Reactions
Gestational Sac / ultrasonography*
Practice Guidelines as Topic
Pregnancy Trimester, First
Prospective Studies
Sensitivity and Specificity
Ultrasonography, Prenatal*
Comment In:
Ultrasound Obstet Gynecol. 2012 Mar;39(3):361; author reply 362   [PMID:  22535629 ]
Ultrasound Obstet Gynecol. 2012 Mar;39(3):362-3; author reply 364-5   [PMID:  22535631 ]

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