Women's experiences of early pregnancy assessment unit services: a qualitative investigation.

OBJECTIVE: To explore the experiences of women who had used an Early Pregnancy Assessment Unit (EPAU) service in the UK and make recommendations for their improvement. DESIGN: Qualitative interview study. SETTING: Early Pregnancy Assessment Units in the UK. SAMPLE: A maximum variation sample of women who had consented to be interviewed having attended one of 26 EPAUs involved in the VESPA study in 2018. METHODS: In-depth telephone interviews with 38 women. A thematic framework analysis was conducted, with a focus on how experiences varied according to EPAU service configuration and clinical pathway. MAIN OUTCOME MEASURES: Women's experiences of EPAU services. RESULTS: We found that EPAUs are highly valued, and women's experiences were generally positive. However, women reported a range of issues that negatively affected their experience. These included difficulties accessing the service, insensitive management of the investigation and treatment options of pregnancy loss, poor communication, insufficient information and a lack of support for their psychological health. These issues were not strongly associated with EPAU configuration or clinical pathway. CONCLUSIONS: Recommendations to improve women's experiences include the separation of EPAUs from general maternity services, and we make suggestions on how to remove barriers to access by reviewing opening hours, how to provide sensitive patient management, such as automatically cancelling appointments and scans following pregnancy loss, and how to improve communication, both with women and their partners as well as with other parts of the health service. TWEETABLE ABSTRACT: Early Pregnancy Assessment Units are highly valued by women but aspects of their care experiences, particularly around sensitive management of pregnancy loss, could be improved.

Predictive value of presence of amniotic sac without visible embryonic heartbeat in diagnosis of early embryonic demise.

OBJECTIVES: To assess the diagnostic value and impact on management of visualizing on ultrasound an amniotic sac without a live embryo (amniotic sac sign). We also examined the potential effect on the number of follow-up visits in early pregnancy units of incorporating this sign into current diagnostic algorithms. METHODS: This was a prospective cohort study of all pregnant women who attended a single specialist early pregnancy unit from July 2017 to November 2018 with symptoms of pain and/or bleeding, or with a history of ectopic pregnancy or miscarriage, at < 14 weeks' gestation. Detailed initial ultrasound findings were documented, including whether an amniotic sac was present in a normally sited intrauterine pregnancy with absence of a live embryo. Women were followed up until a conclusive diagnosis was made. RESULTS: The study included 6012 women who attended our unit with early pregnancy complications during the study period. A conclusive diagnosis was reached on the initial scan in 4221 (70.2%), whilst 1135 (18.9%) women had a pregnancy of uncertain viability and 656 (10.9%) had a pregnancy of unknown location (PUL). All women with a pregnancy of uncertain viability required follow-up ultrasound scans to differentiate between a live pregnancy and early embryonic demise. An amniotic sac in the absence of a live embryo was found in 174/1135 (15.3%) women with a pregnancy of uncertain viability at the initial ultrasound scan. The diagnosis of early embryonic demise was confirmed in all 134 of these women who attended their follow-up scans. The presence of an amniotic sac without a live embryo at the initial visit had a specificity of 100% (95% CI, 98.53-100.00%) and positive predictive value of 100% (95% CI, 97.2-100.0%) for the diagnosis of early pregnancy failure. A total of 1403/6012 (23.3%) women were asked to attend for a follow-up ultrasound scan to resolve diagnostic uncertainties, including 268/656 (40.9%) women with a PUL. The majority of follow-up scans needed to reach a conclusive diagnosis were in women with a pregnancy of uncertain viability (1135/1403 (80.9%)). By using the presence of the amniotic sac sign to diagnose early pregnancy failure at the first visit, the number of follow-up scans for pregnancies of uncertain viability would be reduced by 14.4%, which accounted for 11% of all follow-up scans during the study period. CONCLUSIONS: The finding on ultrasound of an amniotic sac without a live embryo (amniotic sac sign) is a reliable marker of early pregnancy failure and could reduce the number of follow-up scans by 11% in cases of diagnostic uncertainty. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Single-dose systemic methotrexate vs expectant management for treatment of tubal ectopic pregnancy: a placebo-controlled randomized trial.

OBJECTIVE: Methotrexate is used routinely worldwide for the medical treatment of clinically stable women with a tubal ectopic pregnancy. This is despite the lack of robust evidence to show its superior effectiveness over expectant management. The aim of our multicenter randomized controlled trial was to compare success rates of methotrexate against placebo for the conservative treatment of tubal ectopic pregnancy. METHODS: This study took place in two early-pregnancy units in the UK between August 2005 and June 2014. Inclusion criteria were clinically stable women with a conclusive ultrasound diagnosis of a tubal ectopic pregnancy, presenting with a low serum beta human chorionic gonadotropin (ß-hCG) level of < 1500 IU/L. Women were assigned randomly to a single systemic injection of either 50 mg/m2 methotrexate or placebo. The primary outcome was a binary indicator for success of conservative management, defined as resolution of clinical symptoms and decline of serum ß-hCG to < 20 IU/L or a negative urine pregnancy test without the need for any additional medical intervention. An intention-to-treat analysis was followed. RESULTS: We recruited a total of 80 women, 42 of whom were assigned to methotrexate and 38 to placebo. The arms of the study were matched in terms of age, ethnicity, obstetric history, pregnancy characteristics and serum levels of ß-hCG and progesterone. The rates of success were similar for the two study arms: 83% with methotrexate and 76% with placebo. On univariate analysis, this difference was not statistically significant (χ2 (1 degree of freedom) = 0.53; P = 0.47). On multivariate logistic regression, the serum level of ß-hCG was the only covariate found to be significantly associated with outcome. The odds of failure increased by 0.15% for each unit increase in ß-hCG (odds ratio, 1.0015 (95% CI, 1.0002-1.003); P = 0.02). In 14 women presenting with serum ß-hCG of 1000-1500 IU/L, the success rate was 33% in those managed expectantly compared with 62% in those receiving methotrexate. This difference was not statistically significant and a larger sample size would be needed to give sufficient power to detect a difference in the subgroup of women with higher ß-hCG. In women with successful conservative treatment, there was no significant difference in median ß-hCG resolution times between study arms (17.5 (interquartile range (IQR), 14-28.0) days (n = 30) in the methotrexate group vs 14 (IQR, 7-29.5) days (n = 25) in the placebo group; P = 0.73). CONCLUSIONS: The results of our study do not support the routine use of methotrexate for the treatment of clinically stable women diagnosed with tubal ectopic pregnancy presenting with low serum ß-hCG (< 1500 IU/L). Further work is required to identify a subgroup of women with tubal ectopic pregnancy and ß-hCG ≥ 1500 IU/L in whom methotrexate may offer a safe and cost-effective alternative to surgery. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. Comparación entre una sola dosis de metotrexate sistémico y la conducta expectante en el tratamiento de casos de embarazo ectópico tubárico: un ensayo aleatorio controlado con placebo RESUMEN OBJETIVO: El metotrexate se utiliza de modo rutinario en todo el mundo para el tratamiento de las mujeres clínicamente estables con un embarazo ectópico tubárico. Esto sucede a pesar de la falta de evidencia rigurosa que demuestre que su eficacia es superior a la conducta expectante. El objetivo de este ensayo controlado aleatorio multicéntrico fue comparar las tasas de éxito del metotrexate con las de un placebo para el tratamiento cauteloso del embarazo ectópico tubárico. MÉTODOS: Este estudio se llevó a cabo en dos clínicas de control de gestación temprana en el Reino Unido entre agosto de 2005 y junio de 2014. Los criterios de inclusión fueron mujeres clínicamente estables con un diagnóstico ecográfico concluyente de embarazo ectópico tubárico, las cuáles presentaban una concentración sérica baja de la ß hormona coriónica gonadotrópica (ß-hCG) inferior a 1500 UI/L. Las mujeres fueron asignadas aleatoriamente a una sola inyección sistémica de 50 mg/m2 de metotrexate o a placebo. El resultado primario fue un indicador binario del éxito del tratamiento conservador, definido como la resolución de los síntomas clínicos y la disminución en el suero de la ß-hCG a <20 UI/L o una prueba de embarazo negativa en orina sin la necesidad de ninguna intervención médica adicional. Se hizo un análisis por intención de tratar. RESULTADOS: Se reclutó un total de 80 mujeres; a 42 de ellas se les asignó el metotrexate y a 38 el placebo. Los grupos del estudio se realizaron en función de la edad, el origen étnico, los antecedentes obstétricos, las características del embarazo y los niveles séricos de la ß-hCG y la progesterona. Las tasas de éxito fueron similares para los dos grupos de estudio: 83% con metotrexate y 76% con placebo. En el análisis univariante, esta diferencia no fue estadísticamente significativa (χ2 (1 grado de libertad) = 0,53; P = 0,47). En la regresión logística multivariante, el nivel sérico de la ß-hCG fue la única covariable que se encontró significativamente asociada con el resultado. Las probabilidades de fracaso aumentaron en un 0,15% por cada unidad de aumento de la ß-hCG (cociente de probabilidad 1,0015 (IC 95%, 1,0002-1,003); P = 0,02). La tasa de éxito en las 14 mujeres con un nivel sérico de la ß-hCG de 1000-1500 UI/L fue del 33% en las tratadas con conducta expectante frente al 62% en las que recibieron metotrexate. Esta diferencia no fue estadísticamente significativa, por lo que se necesitaría un tamaño de muestra mayor, lo suficiente como para poder detectar diferencias en el subgrupo de mujeres con una ß-hCG más elevada. En las mujeres en las que el tratamiento conservador tuvo éxito, no hubo una diferencia significativa en la mediana de los tiempos de resolución de la ß-hCG entre los grupos del estudio (17,5 (amplitud intercuartílica (IQR), 14-28,0) días (n = 30) en el grupo de metotrexate frente a 14 (IQR, 7-29.5) días (n = 25) en el grupo de placebo; P = 0,73). CONCLUSIONES: Los resultados de este estudio no apoyan el uso rutinario de metotrexate para el tratamiento de las mujeres clínicamente estables diagnosticadas con un embarazo ectópico tubárico que presenta un nivel sérico bajo la ß-hCG (<1500 UI/L). Serán necesarios estudios adicionales para identificar un subgrupo de mujeres con embarazo ectópico tubárico y ß-hCG ≥1500 UI/L para quienes el metotrexate puede ofrecer una alternativa segura y rentable en comparación con la cirugía. : : ,,。。 : 2005820146,2。,,ß(beta human chorionic gonadotropin,ß-hCG)<1500 IU/L。,(50 mg/m2 )。,ß-hCG<20 IU/L,。。 : 80,42,38。2、、、ß-hCG。2:83%,76%。,[χ2 (1)=0.53;P=0.47]。logistic,ß-hCG。ß-hCG,0.15%[,1.0015(95% CI,1.0002~1.003);P=0.02]。14ß-hCG1000~1500 IU/L,33%,62%。,ß-hCG。,2ß-hCG(P=0.73),17.5[(interquartile range,IQR),14~28.0](n=30),14 (IQR,7~29.5)(n=25)。 : 、、ß-hCG(<1500 IU/L)。,ß-hCG>1500 IU/L、。.

ß-hCG resolution times during expectant management of tubal ectopic pregnancies.

BACKGROUND: A subset of women with a tubal ectopic pregnancy can be safely managed expectantly. Expectant management involves a degree of disruption with hospital visits to determine serum ß-hCG (ß-human chorionic gonadotrophin) concentration until the pregnancy test becomes negative and expectant management is considered complete. The length of time required for the pregnancy test to become negative and the parameters that influence this interval have not been described. Information on the likely length of follow up would be useful for women considering expectant management of their tubal ectopic pregnancy. METHODS: This was a retrospective study at a tertiary referral center in an inner city London Hospital. We included women who were diagnosed with a tubal ectopic pregnancy by transvaginal ultrasound between March 2009 and March 2014. During the study period 474 women were diagnosed with a tubal ectopic pregnancy and 256 (54 %) of them fulfilled our management criteria for expectant management. A total of 158 (33 %) women had successful expectant management and in those cases we recorded the diameter of the ectopic pregnancy (mm), the maximum serum ß-hCG (IU/L) and levels during follow up until resolution as well as the interval to resolution (days). RESULTS: The median interval from maximum serum ß-hCG concentration to resolution was 18.0 days (IQR 11.0-28.0). The maximum serum ß-hCG concentration and the rate of decline of ß-hCG were independently associated with the length of follow up. Women's age and size of ectopic pregnancy did not have significant effects on the length of follow up. CONCLUSION: Women undergoing expectant management of ectopic pregnancy can be informed that the likely length of follow up is under 3 weeks and that it positively correlates with initial ß-hCG level at the time of diagnosis.

Diagnosis and management of intramural ectopic pregnancy.

Intramural pregnancy is a rare form of ectopic pregnancy, and little is known about its etiology, prevalence and natural history. There is no consensus regarding the ultrasound criteria necessary for the diagnosis of intramural pregnancy, and management strategies vary depending on the severity of clinical presentation, exact location of the pregnancy, viability and gestational age at diagnosis. We present four cases of intramural pregnancy diagnosed in a single institution that illustrate variability in their clinical presentation and difficulty in reaching the correct diagnosis. We also propose a set of ultrasound criteria to facilitate differential diagnosis between intramural and other types of uterine ectopic pregnancy.

Pregnancy outcomes of women with pruritus, normal bile salts and liver enzymes: a case control study.

BACKGROUND: Obstetric cholestasis (OC) is associated with increased maternal and perinatal complications. Nevertheless, data on pregnancy outcomes of women who experience pruritus on a transient basis, but have normal bile salts and liver function tests (LFT) is scarce. METHODS: The maternal and fetal outcomes of 144 women with pruritus but normal bile salts and LFTs were compared with the next delivered patient without itch who matched for age, ethnicity and parity. RESULTS: The study and control groups had similar mean gestational ages at delivery and birth weights (p>0.05, t test). However, women with pruritus were more likely to have meconium-stained liqor, abnormal intrapartum cardiotocography and postpartum hemorrhage (PPH) (p<0.05, Fisher's exact test). There appears to be a trend towards a higher rate of instrumental delivery (p=0.07) in the study compared to the control group, although this did not reach statistical significance. CONCLUSION: This study suggests that women who have transient pruritus with normal bile salts and liver biochemistry appear to have higher intrapartum and postpartum complications and require increased vigilance. In order to evaluate this finding, further prospective studies will be required.