J. Farren

Defining safe criteria to diagnose miscarriage: prospective observational multicentre study

Objectives 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.) Design Prospective multicentre observational trial. Setting Seven hospital based early pregnancy assessment units in the United Kingdom. Participants 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. Main outcome measures 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.

Post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy: a prospective cohort study

Objectives This is a pilot study to investigate the type and severity of emotional distress in women after early pregnancy loss (EPL), compared with a control group with ongoing pregnancies. The secondary aim was to assess whether miscarriage or ectopic pregnancy impacted differently on the type and severity of psychological morbidity. Design This was a prospective survey study. Consecutive women were recruited between January 2012 and July 2013. We emailed women a link to a survey 1, 3 and 9 months after a diagnosis of EPL, and 1 month after the diagnosis of a viable ongoing pregnancy. Setting The Early Pregnancy Assessment Unit (EPAU) of a central London teaching hospital. Participants We recruited 186 women. 128 had a diagnosis of EPL, and 58 of ongoing pregnancies. 11 withdrew consent, and 11 provided an illegible or invalid email address. Main outcome measures Post-traumatic stress disorder (PTSD) was measured using the Post-traumatic Diagnostic Scale (PDS), and anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Results Response rates were 69/114 at 1 month and 44/68 at 3 months in the EPL group, and 20/50 in controls. Psychological morbidity was higher in the EPL group with 28% meeting the criteria for probable PTSD, 32% for anxiety and 16% for depression at 1 month and 38%, 20% and 5%, respectively, at 3 months. In the control group, no women met criteria for PTSD and 10% met criteria for anxiety and depression. There was little difference in type or severity of distress following ectopic pregnancy or miscarriage. Conclusions We have shown a large number of women having experienced a miscarriage or ectopic pregnancy fulfil the diagnostic criteria for probable PTSD. Many suffer from moderate-to-severe anxiety, and a lesser number depression. Psychological morbidity, and in particular PTSD symptoms, persists at least 3 months following pregnancy loss.

Managing pregnancy of unknown location based on initial serum progesterone and serial serum hCG levels: development and validation of a two‐step triage protocol

A uniform rationalized management protocol for pregnancies of unknown location (PUL) is lacking. We developed a two‐step triage protocol to select PUL at high risk of ectopic pregnancy (EP), based on serum progesterone level at presentation (step 1) and the serum human chorionic gonadotropin (hCG) ratio, defined as the ratio of hCG at 48 h to hCG at presentation (step 2).

Factors to consider in pregnancy of unknown location

The management of women with a pregnancy of unknown location (PUL) can vary significantly and often lacks a clear evidence base. Intensive follow-up is usually required for women with a final outcome of an ectopic pregnancy. This, however, only accounts for a small proportion of women with a pregnancy of unknown PUL location. There remains a clear clinical need to rationalize the follow-up of PUL so women at high risk of having a final outcome of an ectopic pregnancy are followed up more intensively and those PUL at low risk of having an ectopic pregnancy have their follow-up streamlined. This review covers the main management strategies published in the current literature and aims to give clinicians an overview of the most up-to-date evidence that they can take away into their everyday clinical practice when caring for women with a PUL.

OP11.02: Endometrial thickness and its value in triaging women with a pregnancy of unknown location

Objectives: In normal fetuses the CPR falls after 34 weeks’ gestation. However, the cerebroplacental ratio (CPR) is lower in fetuses suffering from fetal growth restriction, and therefore at risk of stillbirth. It is possible that the magnitude or rate of fall could be useful in identifying those fetuses at risk. The aim of this study was to investigate the longitudinal change in small for gestational age (SGA) fetuses that had stillbirth or perinatal death. Methods: A longitudinal study of singleton pregnancies undergoing ultrasound monitoring of fetal biometry and Dopplers. Major structural abnormalities, aneuploidy, genetic syndromes or missing outcomes were excluded. Analysis of repeated measures with multilevel mixed-effects linear model (fixed effects and random effects) was performed. Regression analysis was used to investigate and adjust for potential confounding variables. ROC curve analysis was used to investigate the predictive accuracy. Results: 6906 observations were recorded in 2481 pregnancies: 1546 AGA fetuses, 31 SGA fetuses that had perinatal death, and 903 SGA fetuses that survived. There was a quadratic increase of CPR with GA in the AGA fetuses (p<0.01). CPR values were significantly lower in the SGA compared to the AGA fetuses (p<0.01). Women whose pregnancies were complicated by perinatal death were more likely to be smokers, non-Caucasian, nulliparous and delivered at an earlier GA (p<0.001 for all), compared to those who survived. CPR was significantly associated with the risk of stillbirth and perinatal death (p<0.001 for both). CPR recorded at the initial assessment had AUC 0.77 (95%CI 0.74-0.79; sensitivity 80.7%, specificity 76.6%, PPV 10.5%, NPV 99.1%), while CPR at the last assessment had AUC 0.82 (95%CI 0.79-0.84; sensitivity 80.7%, specificity 81.8%, PPV 13.2%, NPV 99.2%). Conclusions: CPR is a predictor of stillbirth and perinatal death in SGA fetuses, both at the initial and last assessments.

Ultrasound-Guided Laparoscopic Ovarian Wedge Resection in Recurrent Serous Borderline Ovarian Tumours.

Objective The aim of this study was to demonstrate the use of intraoperative ultrasound-guided ovarian wedge resection in the treatment of recurrent serous borderline ovarian tumors (sBOTs) that are too small to be visualized laparoscopically. Methods This was a prospective analysis of all women with recurrent sBOTs that were not visible laparoscopically, who underwent intraoperative ultrasound-guided ovarian wedge resection between January 2015 and December 2016 at the West London Gynaecological Cancer Centre, Imperial College NHS Trust, London, United Kingdom. Results We evaluated 7 patients, with a median age of 35 years (range, 28–39 years). Six women were nulliparous, whereas 1 woman had a single child. Previous surgical intervention left 5 women with a single ovary, whereas the remaining 2 had previous ovarian-sparing surgery. The median size of recurrence was 18 mm (range, 12–37 mm). All women underwent uncomplicated intraoperative guided ovarian wedge resections. Histological assessment confirmed sBOT in all 7 cases. Six of the women remain disease-free. One woman recurred postoperatively with her third recurrence, who previously had bilateral disease and noninvasive implants with microinvasive disease and micropapillary pattern. No cases progressed to invasive disease. The median follow-up time was 12 months (range, 1–20 months). One pregnancy has been achieved postoperatively but resulted in miscarriage. Conclusions Continuous intraoperative ultrasound can be used to facilitate complete tumor excision in recurrent sBOT while minimizing the removal of ovarian tissue in women with recurrent sBOT. It is essential that surgical techniques evolve simultaneously with diagnostic imaging modalities to enable surgeons to treat such pathology.

Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomised control trial with patient preference arm

Objective To determine whether ambulatory (outpatient (OP)) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care. Design Non-blinded randomised control trial (RCT) with patient preference arm. Setting Two multicentre teaching hospitals in London. Participants Women less than 20 weeks’ pregnant with severe NVP and associated ketonuria (>1+). Methods Women who agreed to the RCT were randomised via web-based application to either ambulatory or IP treatment. Women who declined randomisation underwent the treatment of their choice in the patient preference trial (PPT) arm. Treatment protocols, data collection and follow-up were the same for all participants. Main outcome measures Primary outcome was reduction in Pregnancy Unique Quantification of Emesis (PUQE) score 48 hours after starting treatment. Secondary outcome measures were duration of treatment, improvement in symptom scores and ketonuria at 48 hours, reattendances within 7 days of discharge and comparison of symptoms at 7 days postdischarge. Results 152/174 eligible women agreed to participate with 77/152 (51%) recruited to the RCT and 75/152 (49%) to the PPT. Patients were initially compared in four groups (randomised IP, randomised OP, non-randomised IP and non-randomised OP). Comprehensive cohort analysis of participants in the randomised group (RCT) and non-randomised group (PPT) did not demonstrate any differences in patient demographics or baseline clinical characteristics. Pooled analysis of IP versus OP groups showed no difference in reduction in PUQE score at 48 hours (p=0.86). There was no difference in change in eating score (p=0.69), drinking score (p=0.77), well-being rating (p=0.64) or reduction in ketonuria (p=0.47) at 48 hours, with no difference in duration of index treatment episode (p=0.83) or reattendances within 7 days (p=0.52). Conclusions Ambulatory management is an effective direct alternative to IP management of severe NVP. The trial also demonstrated that many women requiring treatment for severe NVP have strong preferences regarding treatment setting, which may need to be considered by care providers, especially given the psychological impact of severe NVP. Trial registration number http://www.isrctn.com/ISRCTN24659467 (March 2014).

Automatic segmentation and measurements of gestational sac using static B-mode ultrasound images

Ultrasound imagery has been widely used for medical diagnoses. Ultrasound scanning is safe and non-invasive, and hence used throughout pregnancy for monitoring growth. In the first trimester, an important measurement is that of the Gestation Sac (GS). The task of measuring the GS size from an ultrasound image is done manually by a Gynecologist. This paper presents a new approach to automatically segment a GS from a static B-mode image by exploiting its geometric features for early identification of miscarriage cases. To accurately locate the GS in the image, the proposed solution uses wavelet transform to suppress the speckle noise by eliminating the high-frequency sub-bands and prepare an enhanced image. This is followed by a segmentation step that isolates the GS through the several stages. First, the mean value is used as a threshold to binarise the image, followed by filtering unwanted objects based on their circularity, size and mean of greyscale. The mean value of each object is then used to further select candidate objects. A Region Growing technique is applied as a post-processing to finally identify the GS. We evaluated the effectiveness of the proposed solution by firstly comparing the automatic size measurements of the segmented GS against the manual measurements, and then integrating the proposed segmentation solution into a classification framework for identifying miscarriage cases and pregnancy of unknown viability (PUV). Both test results demonstrate that the proposed method is effective in segmentation the GS and classifying the outcomes with high level accuracy (sensitivity (miscarriage) of 100% and specificity (PUV) of 99.87%).

OP11.05: Predictors of the successful expectant management of tubal ectopic pregnancy

Objectives: To assess the prognostic value of smaller than expected early Crown–rump length (CRL) to predict the occurrence of subsequent first trimester miscarriage in women with singleton pregnancy conceived by in vitro fertilisation treatment with or without intracytoplasmic sperm injection (IVF/ICSI). Methods: A retrospective observational study of prospectively collected data of first trimester intra-uterine singleton pregnancies after an IVF/ICSI fresh cycle was conducted at a tertiary centre where embryonic transfer is performed at the cleavage stage. Real gestational age (GA) in days was calculated from the date of oocyte retrieval (plus 14 days). CRL was measured at 6 to 10 weeks by transvaginal ultrasound and only pregnancies viable at this stage were considered. GA from CRL, termed estimated GA, was calculated by the software (Astraia®) in use. Discrepancy in days between real and estimated GA was compared between viable and miscarried pregnancies at 11-13 weeks. First trimester miscarriage rate was assessed according to cut-offs (-3, -5 and -7 days of estimated GA). Results: From 282 pregnancies, 256 (90.8%) were viable at 11 to 13 weeks. Miscarried pregnancies had greater discrepancy between real and estimated GA than viable pregnancies (-3.029 days [-4.756 to -1.302], p=0.001). Late first trimester miscarriage occurred in 12/37 (32%) of pregnancies when estimated GA was -3 days than real GA, in 7/12 (58%) when it was -5 days and in 4/7 (85%) when it was -7 days. Miscarriage rate was not influenced by maternal age (p=0.866) nor fertilisation treatment (IVF versus ICSI, p=0.824). Conclusions: There appears to be an association between a smaller than expected early CRL and a higher likelihood of first trimester miscarriage in singleton pregnancies conceived by IVF/ICSI. This data can be useful in clinical practice to assist in the decision of a re-evaluation by early scan.

Intraoperative ultrasound‐guided laparoscopic ovarian‐tissue‐preserving surgery for recurrent borderline ovarian tumor

Borderline ovarian tumors differ from epithelial ovarian carcinomas by presenting at an earlier stage in a younger population and with a more favorable prognosis. Given their preponderance to affect women of reproductive age, particularly in a society in which the age of first pregnancy continues to increase, it is essential to consider future fertility preferences when planning surgical intervention. In women who request fertility preservation, conservative surgery can be considered when the disease is confined to the ovaries. Although such operations, including cystectomy or unilateral salpingo-oophorectomy (USO), are associated with a 2–4-fold increased risk of recurrence compared with radical surgery1, there is virtually no increased risk of mortality2. Following a single recurrence, the prognosis appears very good3 and repeat fertility-preserving surgery is feasible. Figure 1 Ultrasound-guided laparoscopic ovarian-tissue-preserving surgery in case of borderline ovarian tumor. Under transvaginal ultrasound guidance (a), ovary was suspended above level of saline and bipolar diathermy was used to demarcate lesion (b). (c) Demarcated area underwent wedge resection.