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The inclusion criteria were cases of early pregnancy loss, defined as intrauterine pregnancy with reproducible evidence of lost fetal heart activity and/or the lack of increased crown rump length over one week or the persisting presence of an empty sac at less than 12 weeks of gestation [ 10] (empty sac or missed miscarriage) in clinically stable women.
At most ∼1% of ovarioles showed normal morphology and ∼50% of ovarioles contained either an abnormal-looking germarium in an otherwise empty sac of somatic sheath cells or a germarium with a few discrete egg chambers.
Information on repeat scans was lacking in 94 pregnancies (mainly due to a logistical problem at St George's hospital), and repeat scan classification (miscarriage, empty sac, gestational sac+yolk sac, embryo without heartbeat, embryo with heartbeat) was unclear in two, leaving 2749 pregnancies (86.1%) with information on 11-14 week viability, pregnancy type, and repeat scan classification.
Among these 260 pregnancies, 78 presented with an empty sac (six ended as viable, with a maximum mean gestational sac diameter of 12.7 mm), 49 presented with a visible yolk sac without an embryo (eight ended as viable, with a maximum mean gestational sac diameter of 12.3 mm), and 133 presented with an embryo (one ended as viable, with a crown-rump length measurement of 1.6 mm).
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For initially empty sacs, if a yolk sac (with no embryo) is visualised on repeat scan the likelihood of viability is substantially increased.
The vaginal ultrasound criteria for early miscarriage-empty sac are an intra-uterine image consistent with a gestational sac with a mean diameter > 20 mm with no detectable embryonic pole or if the diameter is ≤ 20 mm with no change on rescan at 7 days.
Pregnancies with an empty gestational sac and mean sac diameter of ≥9 mm and still of uncertain viability on repeat scanning never ended as viable, irrespective of the timing of a repeat scan (fig 3).
According to their morphological characteristics ectopics are classified into five different categories: (1) inhomogeneous solid swelling, (2) empty gestation sac, (3) gestation containing a yolk sac, (4) gestational sac containing an embryo with no cardiac activity, (5) gestational sac containing a live embryo.
Overall, 49/947 (5.2%) pregnancies with an empty gestational sac had a mean sac diameter of ≥20 mm: 47 of the 583 (8.1%) non-viable pregnancies and two of the 364 (0.5%) viable pregnancies (table 2 and see supplementary fig S1).
Following these publications, the Royal College of Obstetricians and Gynaecologists immediately changed its guidance to one based on an empty gestational sac of mean gestational sac diameter ≥25 mm or embryo with a crown-rump length ≥7 mm and no heartbeat.
10 This narrative review stated that the absence of an embryo with a heartbeat ≥14 days after a scan showing an empty gestational sac or absence of an embryo heartbeat ≥11 days after a scan showing a gestational sac and yolk sac were both categorically a miscarriage.
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