Clinical predictive value of pre-pregnancy tests for unexplained recurrent spontaneous abortion: a retrospective study.

Introduction: Early prediction and intervention are crucial for the prognosis of unexplained recurrent spontaneous abortion (uRSA). The main purpose of this study is to establish a risk prediction model for uRSA based on routine pre-pregnancy tests, in order to provide clinical physicians with indications of whether the patients are at high risk. Methods: This was a retrospective study conducted at the Prenatal Diagnosis Center of Henan Provincial People's Hospital between January 2019 and December 2022. Twelve routine pre-pregnancy tests and four basic personal information characteristics were collected. Pre-pregnancy tests include thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine thyroid (FT4), thyroxine (TT4), total triiodothyronine (TT3), peroxidase antibody (TPO-Ab), thyroid globulin antibody (TG-Ab), 25-hydroxyvitamin D [25-(OH) D], ferritin (Ferr), Homocysteine (Hcy), vitamin B12 (VitB12), folic acid (FA). Basic personal information characteristics include age, body mass index (BMI), smoking history and drinking history. Logistic regression analysis was used to establish a risk prediction model, and receiver operating characteristic (ROC) curve and decision curve analysis (DCA) were employed to evaluate the performance of prediction model. Results: A total of 140 patients in uRSA group and 152 women in the control group were randomly split into a training set (n = 186) and a testing set (n = 106). Chi-square test results for each single characteristic indicated that, FT3 (p = 0.018), FT4 (p = 0.048), 25-(OH) D (p = 0.013) and FA (p = 0.044) were closely related to RSA. TG-Ab and TPO-Ab were also important characteristics according to clinical experience, so we established a risk prediction model for RSA based on the above six characteristics using logistic regression analysis. The prediction accuracy of the model on the testing set was 74.53%, and the area under ROC curve was 0.710. DCA curve indicated that the model had good clinical value. Conclusion: Pre-pregnancy tests such as FT3, FT4, TG-Ab, 25-(OH)D and FA were closely related to uRSA. This study successfully established a risk prediction model for RSA based on routine pre-pregnancy tests.

Guidelines for NGS procedures applied to prenatal diagnosis by the Spanish Society of Gynecology and Obstetrics and the Spanish Association of Prenatal Diagnosis.

OBJECTIVE: This document addresses the clinical application of next-generation sequencing (NGS) technologies for prenatal genetic diagnosis and aims to establish clinical practice recommendations in Spain to ensure uniformity in implementing these technologies into prenatal care. METHODS: A joint committee of expert obstetricians and geneticists was created to review the existing literature on fetal NGS for genetic diagnosis and to make recommendations for Spanish healthcare professionals. RESULTS: This guideline summarises technical aspects of NGS technologies, clinical indications in prenatal setting, considerations regarding findings to be reported, genetic counselling considerations as well as data storage and protection policies. CONCLUSIONS: This document provides updated recommendations for the use of NGS diagnostic tests in prenatal diagnosis. These recommendations should be periodically reviewed as our knowledge of the clinical utility of NGS technologies, applied during pregnancy, may advance.

Evaluation of a Commercial Pregnancy Test Using Blood or Plasma Samples in High-Producing Dairy Cows.

This study evaluated a commercial pregnancy-associated glycoproteins (PAGs)-based pregnancy test using whole blood or plasma samples during early pregnancy (28-55 days of gestation) in high-producing dairy cows. Transrectal ultrasonography was used as the gold standard method. The study population constituted of 284 cows. False positive diagnoses were recorded from Day 60 to 89 and from Day 60 to 99 postpartum in blood and plasma samples, respectively. In early pregnancy screening, correct positive diagnoses were recorded in 75% and 100% of blood and plasma samples, respectively. High milk production was associated with negative results in blood samples and with the lowest test line intensity in plasma samples. False positive or negative diagnoses were recorded in 0% of both types of samples in cows previously diagnosed as pregnant and showing signs of estrus. In conclusion, the use of plasma was more effective than the use of blood in early pregnancy diagnosis. In cows previously diagnosed as pregnant and showing signs of estrus, both types of samples showed the same results. Because of large individual variations, normal single pregnancies could not be differentiated from twin pregnancies, from pregnancies with a recently dead conceptus, or from pregnancies that experienced subsequent pregnancy loss.

Congenital Syphilis Prevention Challenges, Pacific Coast of Colombia, 2018-2022.

High incidences of congenital syphilis have been reported in areas along the Pacific coast of Colombia. In this retrospective study, conducted during 2018-2022 at a public hospital in Buenaventura, Colombia, we analyzed data from 3,378 pregnant women. The opportunity to prevent congenital syphilis was missed in 53.1% of mothers because of the lack of syphilis screening. Characteristics of higher maternal social vulnerability and late access to prenatal care decreased the probability of having >1 syphilis screening test, thereby increasing the probability of having newborns with congenital syphilis. In addition, the opportunity to prevent congenital syphilis was missed in 41.5% of patients with syphilis because of the lack of treatment, which also increased the probability of having newborns with congenital syphilis. We demonstrate the urgent need to improve screening and treatment capabilities for maternal syphilis, particularly among pregnant women who are more socially vulnerable.

Teratogenicity and Reactive Oxygen Species after transient embryonic hypoxia: Experimental and clinical evidence with focus on drugs causing failed abortion in humans.

Teratogenicity and Reactive Oxygen Species after transient embryonic hypoxia: Experimental and clinical evidence with focus on drugs with human abortive potential. Reactive Oxygen Species (ROS) can be harmful to embryonic tissues. The adverse embryonic effects are dependent on the severity and duration of the hypoxic event and when during organongenesis hypoxia occurs. The vascular endothelium of recently formed arteries in the embryo is highly susceptible to ROS damage. Endothelial damage results in vascular disruption, hemorrhage and maldevelopment of organs, which normally should have been supplied by the artery. ROS can also induce irregular heart rhythm in the embryo resulting in alterations in blood flow and pressure from when the tubular heart starts beating. Such alterations in blood flow and pressure during cardiogenesis can result in a variety of cardiovascular defects, for example transpositions and ventricular septal defects. One aim of this article is to review and compare the pattern of malformations produced by transient embryonic hypoxia of various origins in animal studies with malformations associated with transient embryonic hypoxia in human pregnancy due to a failed abortion process. The results show that transient hypoxia and compounds with potential to cause failed abortion in humans, such as misoprostol and hormone pregnancy tests (HPTs) like Primodos, have been associated with a similar spectrum of teratogenicity. The spectrum includes limb reduction-, cardiovascular- and central nervous system defects. The hypoxia-ROS related teratogenicity of misoprostol and HPTs, is likely to be secondary to uterine contractions and compression of uterinoplacental/embryonic vessels during organogenesis.

Understanding factors influencing home pregnancy test use among women in western Kenya: A qualitative analysis.

Background: There are limited data on home pregnancy test use among women in low-and-middle-income countries. A prior survey found that only 20% of women in western Kenya used a home pregnancy test to confirm their pregnancies before going to antenatal care. This qualitative study aims to understand why women do not use home pregnancy tests in early pregnancy. Methods: From April 2021 to July 2021, we interviewed women from four antenatal care clinics in Homa Bay and Siaya counties. We recruited women previously enrolled in the PrEP Implementation for Mothers in Antenatal care (PrIMA) study, a cluster-randomized trial that evaluated the best approaches to implementing PrEP in maternal and child health clinics in Western Kenya (NCT03070600). Interviews were conducted via phone, audio recorded, translated, and transcribed verbatim. We coded and analyzed the transcripts to capture factors influencing women's capability, opportunity, and motivation to use home pregnancy tests. Results: We conducted 48 semistructured interviews with women aged 21-42 years. Twenty-seven women did not use a home pregnancy test in their most recent pregnancy. Seventeen of these women reported not using a home pregnancy test before. Lack of knowledge, mistrust in the accuracy of tests, preferring to rely on signs and symptoms of pregnancy or get a test from the health facility, cost, and accessibility were key barriers to home pregnancy test use. Conclusion: Improving the uptake of home pregnancy testing during early pregnancy will require efforts to enhance community knowledge of test use and associated benefits and reduce cost burdens by making tests more affordable and accessible.

Implications of using home urine pregnancy tests versus facility-based tests for assessment of outcome following medication abortion provided via telemedicine.

OBJECTIVES: To assess whether planning high-sensitivity urine pregnancy tests (HSPT) rather than facility-based tests for medication abortion follow-up may increase risk of unplanned clinical visits or procedural completion of the abortion. STUDY DESIGN: We used data from the TelAbortion Project, a 5-year study assessing the safety and feasibility of providing mifepristone and misoprostol by telemedicine and mail in the United States. We categorized participants by whether the pretreatment follow-up plan included HSPT at home 3-5 weeks after treatment or facility-based tests (ultrasound or serum human chorionic gonadotropin) within 2 weeks after treatment. We used multivariable logistic regression to compare likelihood of post-treatment unplanned, abortion-related clinical visits and procedural intervention in these groups. RESULTS: Of 1324 patients who planned HSPT follow-up and 576 who planned facility-based tests, 85% and 83%, respectively, provided outcome information. Post-treatment clinical visits were less frequent in the HSPT group (19%) than in the facility-based test group (79%); most of the latter were to obtain the planned test. However, unplanned, abortion-related visits were significantly more common in the HSPT group (adjusted risk difference: 6.5%; p < 0.01). The likelihood of procedural completion did not differ by group. Planned follow-up test was not associated with delay in procedural completion or detection of ongoing pregnancy. CONCLUSIONS: Follow-up of medication abortion with home HSPT was associated with fewer post-treatment clinical visits, modestly more unplanned, abortion-related clinical visits, and no increase in the risk of procedural interventions or delayed identification or management of treatment failures. This option is an appropriate follow-up approach after medication abortion. IMPLICATIONS: Use of home high-sensitivity pregnancy tests rather than facility-based tests for outcome assessment after medication abortion is associated with a modest increase in unplanned clinical visits but does not lead to an increase in procedural interventions or delays identification and management of treatment failure.

False-positive urine pregnancy screening tests are uncommon in the hospital setting among patients with bowel-containing urinary tract reconstruction.

PURPOSE: False-positive urine pregnancy screening tests (UPST) have been reported among patients with bowel-containing urinary reconstruction (BCUR). However, the true frequency of such inaccurate results, which have been attributed to urinary mucous or other proteins interfering with or mimicking the binding of beta-HCG in the assay, is unknown in this population. We sought to determine the incidence of false-positive pregnancy screening tests among this patient population at our institution. MATERIALS AND METHODS: Using existing databases of patients with spina bifida, bladder exstrophy, and genitourinary rhabdomyosarcoma, we identified female patients with BCUR who had UPST over a 10-year period as screening prior to procedures or imaging. Patient and test result information was recorded. RESULTS: A total of 120 patients with a history of BCUR were identified: 33 with spina bifida, 73 within the exstrophy-epispadias complex (EEC), and 14 with genitourinary rhabdomyosarcoma. Of this group, 46 patients (38%) had at least one UPST during the study period; 15 had 1 UPST, 6 had 2 UPSTs, 4 had 3 UPSTs, and 21 had greater than 3 UPSTs, for a total of 244 UPST in this cohort. UPSTs used at our institution included Sure-Vue brand and Alere brand (HCG sensitivity 20 mIU/ml). Types of BCUR included ileal enterocystoplasty in 25 patients, colon enterocystoplasty in 6, stomach enterocystoplasty in 5, composite enterocystoplasty in 7, and continent catheterizable channel alone (e.g. Yang-Monti, appendicovesicostomy) in 3 patients. Of the 244 UPSTs in patients with BCUR, zero (0%) were positive. CONCLUSIONS: Despite reports in the literature that false-positive UPST are common among patients with bowel-containing urinary diversions, we found no positive UPST among patients with BCUR in the healthcare setting. False-positive UPST in the home setting may be due to variability in sensitivity thresholds, binding agents, technical errors in test technique, kit quality control, or other factors.

Detection of copy number variants associated with late-onset conditions in ~16 200 pregnancies: parameters for disclosure and pregnancy outcome.

BACKGROUND: Copy number variants (CNVs) associated with late-onset medical conditions are rare but important secondary findings in chromosomal microarray analysis (CMA) performed during pregnancy. Here, we critically review the cases at two tertiary centres to assess the criteria which guide the disclosure of such findings and develop a disclosure decision tool (DDT) aimed at facilitating disclosure decision. Parental decisions on receiving CNVs associated with risks for late-onset conditions were also recorded. METHODS: Prenatal CMAs in Hadassah and Shaare Zedek Medical Centers from November 2013 to October 2021 were reviewed for CNVs associated with late-onset conditions. The DDT proposed uses a five-parameter scoring system, which considers the severity, median age of onset, penetrance, understanding of genotype-phenotype correlation and actionability of the finding. RESULTS: Out of 16 238 prenatal CMAs, 16 (0.1%) harboured CNVs associated with late-onset conditions, 15 of which were disclosed. Outcome information was available on 13 of the 16 pregnancies, all of which continued to delivery. CONCLUSIONS: Our suggested DDT will help clinicians to quantitatively weigh the variables associated with CNVs of this type and arrive at a well thought out clinical decision regarding disclosure. Although the prevalence of late-onset conditions as a major finding in the prenatal setup is low, it is expected to rise with the increasing use of non-invasive CMA testing and whole exome and genome sequencing.

False positive pregnancy tests in pediatric patients with augmentation enterocystoplasty.

PURPOSE: Our primary aim was to determine the prevalence of positive over-the-counter (OTC) pregnancy tests among pediatric female and male patients who had undergone augmentation enterocystoplasty. A secondary aim was to determine whether patient factors or urinalysis (UA) results were associated with false positive OTC pregnancy test results in patients with a history of augmentation enterocystoplasty. METHODS: Patients at a tertiary pediatric hospital who had previously undergone augmentation enterocystoplasty, Mitrofanoff appendicovesicostomy only, and age- and sex-matched controls were prospectively recruited. Urine samples were obtained, and two OTC pregnancy tests were conducted - OTC Test A reported the ability to detect pregnancy at hCG levels as low as 9.6 mIU/mL, while OTC Test B reported positive pregnancy test results at hCG levels ≥25 mIU/mL. A point of care (POC) pregnancy test and UA were also completed. Mann-Whitney U tests and Fisher's exact tests were used to assess whether patient factors or UA results were associated with false positive pregnancy test results. RESULTS: Fifty pediatric patients were enrolled, including 20 with augmentation enterocystoplasty, 20 age- and sex-matched controls, and 10 with Mitrofanoff appendicovesicostomy only. Among the 20 patients who had undergone augmentation cystoplasty, 15 (75.0%) had positive pregnancy test results on OTC Test A, including 11/13 (84.6%) females and 4/7 (57.1%) males. No control patients or patients with Mitrofanoff appendicovesicostomy only had a positive test. No patients had positive pregnancy test results on OTC Test B or the POC test. While patients with augmentation enterocystoplasty were significantly more likely to test positive for blood (p = 0.01), nitrate (p = 0.03), and leukocytes (p < 0.0001), these factors were not significantly associated with false positive pregnancy results. No patient factors or UA results were associated with increased likelihood of false positive OTC pregnancy test results. CONCLUSIONS: These findings indicate that sensitive OTC pregnancy tests that detect low quantities of hCG in urine may result in false positive results among patients who have undergone augmentation enterocystoplasty. Female patients of reproductive age with bladder augmentations should be counseled regarding appropriate pregnancy testing options. Additional research is needed to determine the mechanism responsible for false positive pregnancy tests in this patient population.

Embarazo ectópico roto con fracción beta de la hormona gonadotropina coriónica humana negativa: reporte de caso / Ruptured ectopic pregnancy with negative human chorionic gonadotropin hormone beta fraction: case report

Resumen El embarazo ectópico roto es una emergencia quirúrgica cuyo diagnóstico, gracias a la interrelación de la cuantificación de la fracción beta de la hormona gonadotropina coriónica humana (HCG-β) y los hallazgos ultrasonográficos, se ha hecho más preciso. Sin embargo, el diagnóstico se vuelve difícil cuando clínicamente se encuentran datos sugestivos de embarazo ectópico con una HCG-β negativa. Presentamos el caso de una mujer de 25 años acude a valoración por referir 12,2 semanas de retraso menstrual, asociado a sangrado transvaginal y signos de irritación peritoneal, que cuenta con HCG-β negativa (< 5 mUI/ml). Se realizó un rastreo ultrasonográfico encontrando abundante líquido libre en cavidad, sin evidencia de embarazo intrauterino. Ante la alta sospecha de embarazo ectópico se realizó laparotomía exploradora, encontrando hallazgos sugestivos de embarazo ectópico roto, y se realizó salpingectomía. Finalmente, en el estudio posoperatorio se confirmó por histopatología un embarazo ectópico roto. Existen muy pocos reportes en la literatura internacional de pacientes con características clínicas de embarazo ectópico roto, con HCG-β negativa. Es importante la difusión de este tipo de casos con la finalidad de mejorar los abordajes diagnósticos y no restar importancia ante la sospecha clínica, a pesar de presentar una HCG-β negativa.

Abstract Broken ectopic pregnancy is a surgical emergency that due to the relation between the serum quantification of the of the beta subunit of human chorionic gonadotropin (β-HCG) and the ultrasonographic findings, there have been improvements to reach a precise diagnosis. However, there are very few reported cases in the literature where a broken ectopic pregnancy is described with negative serum results in β-HCG. We present a case report of a 25-year-old patient came to the evaluation for referring 12.2 weeks of menstrual delay, associated with transvaginal bleeding and data of peritoneal irritation, she had a negative β-HCG fraction (< 5 mIU/ml). A scan was performed ultrasound finding abundant free fluid in the cavity, without evidence of intrauterine pregnancy. Given the high suspicion of ectopic pregnancy, an exploratory laparotomy was performed, finding findings suggestive of a ruptured ectopic pregnancy, a salpingectomy was performed. Finally, in the postoperative study, a ruptured ectopic pregnancy was confirmed by histopathology. There are very few reported internationally were found a patient with clinical characteristics of broken ectopic pregnancy, with a β-HCG negative. It is important the scientific diffusion of this type of cases with the purpose of improving the diagnostic approaches and not underestimating importance to the clinical suspicion, despite presenting negative β-HCG results.

Early detection of pregnancy after IVF and embryo transfer with hyperglycosylated HCG versus Elecsys HCG+ß assay.

RESEARCH QUESTION: Is measurement of hyperglycosylated HCG (hHCG) superior to beta-HCG (HCG+ß) for early pregnancy detection after IVF and embryo transfer? DESIGN: Blood samples were collected on day 4 (+1), 7 (+1) and 11 (+2) after embryo transfer from women aged 18-45 years undergoing first or second fresh or frozen IVF embryo transfer cycles. Biochemical pregnancy was assessed on-site by HCG determination on day 11; clinical pregnancy was assessed by ultrasound on day 21 (+4/-3). Serum hHCG (immunochemiluminometric assay) and HCG+ß (Elecsys® HCG+ß assay) concentrations were measured. Performance of hHCG and HCG+ß for predicting pregnancy was evaluated and cut-offs selected. RESULTS: In total, 155 women were enrolled and underwent IVF and embryo transfer. Area under the curve (AUC) (95% CI) on day 4 was not significantly different for hHCG (AUC 0.88; 95% CI 0.83 to 0.94) and HCG+ß (AUC 0.90; 95% CI 0.84 to 0.95), as was predictive performance on day 7 and 11, with higher AUC estimates compared with day 4. Applying cut-offs derived according to Youden's index on day 4 (hHCG, 100 pg/ml; HCG+ß, 1.30 mIU/ml), both biomarkers demonstrated high negative predictive values for ruling out pregnancy (hHCG, 83.8%; HCG+ß, 82.8%) and high positive predictive values for ruling in pregnancy (hHCG, 89.0%; HCG+ß, 84.9%) on day 21. Diagnostic performance improved from day 4 to day 11. CONCLUSIONS: Predictive performance for early pregnancy post-IVF embryo transfer of day-5 blastocysts was not significantly different for hHCG and HCG+ß; hHCG superiority over HCG+ß was not shown.

Home pregnancy test use and timing of pregnancy confirmation among people seeking health care.

OBJECTIVES: Understanding the timing of pregnancy suspicion and confirmation, including the role of home pregnancy tests, can facilitate earlier entry into pregnancy-related care and identify individuals likely to be impacted by gestation-based abortion restrictions. STUDY DESIGN: We use data from 259 pregnant individuals participating in a cross-sectional survey at 8 primary and reproductive health care clinics in 6 U.S. states (2016-2017). We use regression models to identify differences in utilization of HPTs, barriers to use, and to compare gestational duration at pregnancy confirmation. RESULTS: Three-quarters (74%) of respondents took a home pregnancy test as the first step in confirming pregnancy; this figure was lower among adolescents versus young adults (65 vs 81%, p = 0.01). Two-thirds (64%) reported delays in home testing, higher among adolescents (85%). People taking a test at home confirmed pregnancy 10 days earlier than those first testing at a clinic (41.3 vs 51.8 days gestation, p = 0.02). Those that did not test at home cited concerns about test accuracy (42%) and difficulties accessing one (26%). While overall 21% confirmed pregnancy at ≥7 weeks gestation, and 35% at ≥6 weeks, confirmation at ≥7 weeks was higher among adolescents versus young adults (47 vs 13%, p = 0.001), Latina versus white women (28 vs 11%, p = 0.02), food insecure versus secure women (28 vs 17%, p = 0.06), and people with unplanned versus planned/mistimed pregnancies (25 vs 13%, p = 0.07). CONCLUSIONS: Home pregnancy testing is common and associated with earlier pregnancy confirmation. Still, barriers to at-home testing are evident, particularly among adolescents. Efforts to expand access to home pregnancy tests and increase knowledge about their accuracy may be impactful in increasing utilization. IMPLICATIONS: While at home pregnancy testing is common and facilitates earlier confirmation of pregnancy, one in 5 confirm pregnancy at 7 weeks gestation or later (and one in 3 do so at 6 weeks or later). Gestational bans in the first trimester will disproportionately prevent young people, people of color, and those living with food insecurity from being able to access abortion.

Effect of pregnancy tests on demand for family planning: evidence from a randomized controlled trial in Uganda.

BACKGROUND: Unmet need for family planning and unintended pregnancies are high in developing countries. Home pregnancy tests help women determine their pregnancy status earlier and the confirmation of a negative pregnancy status can facilitate the adoption of family planning. This study provides the first experimental evidence of the effect of access to pregnancy tests on women's demand for modern family planning. METHODS: A randomized controlled trial was conducted among 810 women of reproductive age in northern Uganda. During a baseline survey, women were randomly allocated to either: (1) an offer to take a hCG urine pregnancy test during the survey (on-the-spot pregnancy test) (N = 170), (2) an offer of a home pregnancy test kit to be used at any time in the future (future-use pregnancy test) (N = 163), (3) offers of both on-the-spot and future-use pregnancy tests (N = 153), or (4) a control group (N = 324). Future-use pregnancy tests were offered either for free, or randomly assigned prices. Approximately 4 weeks after the baseline survey, a follow-up survey was conducted; modern contraception methods were made available at no charge at local community outreach centers. RESULTS: When offered a free, on-the-spot pregnancy test, 62 percent of women accepted (N = 200). Almost all, 97 percent (N = 69), of women offered a free future-use pregnancy test strip, accepted it. Purchases of future-use pregnancy tests declined with price. The offer of either on-the-spot, future-use tests, or both, have no overall large or statistically significant effects on the take-up of modern family planning. CONCLUSION: Demand for pregnancy tests is high and access to pregnancy tests has the potential to facilitate the demand for family planning. At the same time, more research is needed to understand underlying beliefs about pregnancy status and risk that guide behaviors ultimately important for maternal and neonatal health. Trial registration The study was pre-registered in July 2018 for AEA RCT registry (AEARCTR-0003187) and clinicaltrials.gov (NCT03975933). Registered 05 June 2019, https://clinicaltrials.gov/ct2/show/record/NCT03975933.

Women in developing countries, especially in Africa, have high-unmet needs for family planning as well as high-unintended rates of pregnancy. At the same time, they may learn their pregnancy status later than women in higher-income countries due to irregular menstrual periods, malnutrition, or limited access to home pregnancy tests. Better awareness of pregnancy status can lead to the facilitation of family planning uptake. This paper experimentally evaluates the effect of the provision of home pregnancy tests on family planning take-up among Ugandan women. We find high demand for pregnancy tests among women when offered. At the same time, we find no impact of pregnancy tests on the take-up of free family planning at local community outreach centers. Demand for pregnancy tests is high and access to pregnancy tests has the potential to facilitate the demand for family planning. This study suggests that more research is needed to understand underlying beliefs about pregnancy status and risk that guide behaviors ultimately important for maternal and neonatal health.

False negative point-of-care urine pregnancy tests in an urban academic emergency department: a retrospective cohort study.

STUDY OBJECTIVE: To determine the prevalence of false negative point-of-care (POC) urine pregnancy tests among emergency department (ED) patients and among those with abdominal pain or vaginal bleeding. METHODS: We identified all female patients, ages 14-50 years without prior hysterectomy who had a negative POC urine pregnancy test (beta subunit of human chorionic gonadotropin [ß-hCG]) performed by trained clinical staff in the ED between September 1, 2017 and December 31, 2018, as well as a subgroup we defined a priori as "high risk" for early pregnancy complications based on a triage chief complaint (text) of abdominal pain or vaginal bleeding. We identified those with a positive urine ß-hCG, serum ß-hCG >5 mIU/mL, or a diagnosis of pregnancy within 3 months of the initial ED visit (index visit). We used structured chart review with American College of Obstetrics and Gynecology guidelines to determine pregnancy diagnosis and outcomes (ectopic, intrauterine, abnormal including spontaneous abortion, and unknown), the date of conception, and whether the pregnancy was present at the index visit. RESULTS: Of 10,924 visits with a negative urine pregnancy test result that were screened for a pregnancy outcome, 171 (1.6%, 95% confidence interval [CI] = 1.4, 1.8) had a pregnancy present at the index visit. Diagnoses were ectopic (n = 12, 7.0%), intrauterine (n = 71, 41.5%), abnormal (n = 77, 45.0%), and unknown (n = 11, 6.4%). Of the 2732 patients with high-risk complaints, 97 (3.6%, 95% CI = 2.9, 4.3) had a pregnancy present at the index visit (relative risk of a pregnancy diagnosis 3.9, 95% CI = 2.9,5.3), including 10/12 ectopic (83%), 58/77 abnormal (75%), and 25/71 intrauterine pregnancies (35%). Serum ß-hCG ranged from 2 mIU/mL to above assay (median = 119.5, interquartile range = 957.5). CONCLUSION: Although false negative urine pregnancy tests were uncommon, multiple pregnancy diagnoses were missed, including ectopic pregnancies. False negatives were more common among patients with abdominal pain or vaginal bleeding. Concurrent serum ß-hCG levels demonstrated a broad distribution.

Over-the-counter access to levonorgestrel emergency contraception in South Texas: Does Over-the-counter mean ready to buy?

OBJECTIVE: To determine the percentage of pharmacies in Hidalgo County, Texas, with unrestricted over-the-counter access to levonorgestrel emergency contraceptive pills (ECPs). Unrestricted over-the-counter access means product is available directly to consumer on store shelf, in-stock the day of data collection, and with no security barriers present (such as locked cabinet or individual locked product container), and to compare this access to that of other reproductive health items. STUDY DESIGN: We conducted in-person secret shopper surveys from October 2018 to March 2019, recording in-stock over-the-counter availability of levonorgestrel ECPs, security barriers, and price. We collected the same information for condom multipacks, ovulation prediction test kits, and pregnancy tests. RESULTS: Out of the 76 pharmacies surveyed, 31 (40.8%) sold levonorgestrel ECPs over-the-counter, 23 (30.3%) had product in-stock over-the-counter and two (2.6%) had unrestricted over-the-counter access. Other reproductive health items such as condom multipacks, ovulation prediction test kits and pregnancy tests had unrestricted over-the-counter access in at least 33 (43.4%, p < 0.01) pharmacies. Of the chain pharmacies, 30 (73.2%) sold levonorgestrel ECPs over-the-counter with and without security barriers, while only one (2.9%) of the 35 independent pharmacies sold levonorgestrel ECPs over-the-counter with security barriers (p < 0.001). CONCLUSIONS: While previous research has noted high prevalence of levonorgestrel ECP availability in pharmacies, potential purchasers of over-the-counter levonorgestrel ECPs encounter access barriers not associated with other reproductive health products. These additional access barriers to levonorgestrel ECPs may increase consumer discomfort, decrease privacy, and delay access. IMPLICATIONS: Advocacy efforts may be needed to promote unrestricted access to over-the-counter emergency contraceptives on par with other reproductive health items.

Recommendations for validation testing of home pregnancy tests (HPTs) in Europe.

Home pregnancy tests (HPTs) available in Europe include accuracy and other performance claims listed on their packaging. Due to the lack of guidance on the standardisation of such products, it is often difficult to replicate these claims when tested on a clinical sample, whether in a laboratory setting or by lay users. The In Vitro Diagnostic Regulation is a set of requirements that mandate comprehensive validation data on human pregnancy tests and other in vitro devices. It is due to replace the current European Directive (98/79/EC) and fully implemented in Europe by 2022. In June 2019, a panel of seven experts convened to discuss the validation studies required to provide the information needed to meet the new regulation for HPTs in Europe and proposed 15 recommendations for best practice. Defining best practice at all stages of validation of these important tests may ensure that tests marketed in Europe are fit for purpose, enabling lay users to be confident of the high quality of the HPT results they obtain. The panelists believe that the recommendations proposed here for the validation of HPTs may constructively contribute to improved standardisation of validation procedures in Europe.

Prenatal features in Beckwith-Wiedemann syndrome and indications for prenatal testing.

BACKGROUND: Most cases of Beckwith-Wiedemann spectrum (BWSp) are diagnosed after birth and few studies evaluated the prenatal phenotype; here, we investigate these aspects in a large series of patients with BWSp. METHODS: Eighty-nine patients with BWSp recruited through the BWSp Internal Registry of the Pediatric Genetics Unit of the Regina Margherita Children's Hospital of Torino and through the Italian Association of Patients with BWSp. Data collection was conducted through administration of a personalised questionnaire, interview to patients' parents, review of the clinical records, including prenatal ultrasound (US) and biochemical screening tests, physical examination and review of clinical and molecular data of the patients. RESULTS: Seventeen patients (19.1%) were conceived through assisted reproductive techniques (ART). Twinning occurred in nine pregnancies (three from ART). Pregnancy biochemical screening tests showed increased alpha-fetoprotein (1.52±0.79 multiples of median (MoM), p=0.001), uEstriol (1.37±0.38 MoM, p<0.001) and total human chorionic gonadotrophin (2.14±2.12 MoM, p=0.008) at 15-18 weeks (n=28). Morphology US scan revealed abdominal and head circumferences higher than normal (1.42±1.10 SD scores, p<0.001 and 0.54±0.88, p<0.001, respectively) with normal femur lengths. Sixty-four cases (71.9%%) had a various combination of US findings, including macrosomia (n=32), omphalocele (n=15), enlargement of abdominal organs (n=6), macroglossia (n=11), adrenal cysts/masses (n=2), nephroureteral anomalies (n=11), polyhydramnios (n=28), placental enlargement (n=2) or mesenchymal dysplasia (n=4). CONCLUSION: We propose a clinical scoring system for prenatal molecular investigations defining major, minor and supportive criteria among the several features often observed prenatally in BWSp.

Acretismo placentario en el primer trimestre del embarazo como causa de choque hipovolémico: reporte de un caso / Placentary acretism in the first quarter of pregnancy as a cause of hypovolemic shock: a case report

Resumen ANTECEDENTES: El acretismo es la adherencia anormal de la placenta al miometrio debida a la ausencia parcial o total de la decidua basal y desarrollo incompleto de la capa de Nitabuch. CASO CLÍNICO: Paciente de 45 años, con antecedente de tres embarazos, dos abortos, una cesárea y amenorrea de 12 semanas. El padecimiento actual se inició dos días antes, con sangrado transvaginal intermitente. A su ingreso a Urgencias se encontró con datos de bajo gasto e inmediatamente pérdida del estado de alerta; tensión arterial 40-20 mmHg, frecuencia cardiaca de 125 lpm. La parte posterior del cuello uterino se encontró dehiscente, con sangrado transvaginal abundante, prueba inmunológica de embarazo positiva, fracción β-GCH de 2878 mU/mL. Al asociar los datos de la exploración física se integró el diagnóstico de aborto incompleto y se ingresó a la unidad tocoquirúrgica, para legrado uterino instrumentado. CONCLUSIONES: De acuerdo con las búsquedas bibliográficas, todo indica que éste es el primer reporte mexicano de un caso de acretismo placentario en el primer trimestre del embarazo. Se sugiere la búsqueda de factores de riesgo que permitan la sospecha y faciliten establecer el diagnóstico de acretismo placentario a partir de las primeras semanas de embarazo para evitar desenlaces obstétricos fatales.

Abstract BACKGROUND: Accretism is the abnormal adherence of the placenta to the myometrium due to partial or total absence of the basal decidua and incomplete development of the Nitabuch's layer. CLINICAL CASE: 45-year-old patient, with a history of three pregnancies, two abortions and one cesarean section; amenorrhea of 12 weeks. The current condition started two days earlier, with intermittent transvaginal bleeding. On admission to the ED she was found to have low output and immediate loss of alertness; blood pressure 40-20 mmHg, heart rate 125 bpm. The posterior cervix was found to be dehiscent, with abundant transvaginal bleeding, positive immunological pregnancy test, HCG fraction 2878 mU/mL. By associating the physical examination data, the diagnosis of incomplete abortion was integrated, and she was admitted to the tocosurgical unit, for instrumented uterine curettage. CONCLUSIONS: According to the bibliographic searches, everything indicates that this is the first Mexican report of a case of placental accretism in the first trimester of pregnancy. It is suggested to search for risk factors that allow suspicion and facilitate the diagnosis of placental accretism from the first weeks of pregnancy to avoid fatal obstetric outcomes.