Self-assessment of success of early medical abortion using a self-performed urine pregnancy test.

Purpose: The European Society of Contraception Expert Group on Abortion identified as one of its priorities the need to disseminate up-to-date evidence-based information on the use of urine pregnancy tests by women for the self assessment of the success of early medical abortion (EMA). Methods and materials: A concise communication was produced which summarises the latest research in an easy-to-read format suitable for busy clinicians. Information about individual urinary pregnancy tests is presented in boxes for ease of reference. Results: Urinary pregnancy tests (low sensitivity, high sensitivity and multilevel) can be used in combination with signs and symptoms of pregnancy to exclude an ongoing pregnancy after EMA. Conclusion: Women are able to determine the success of early medical abortion (EMA) themselves using a combination of signs, symptoms and a urine pregnancy test. This simplifies EMA, expands the range of professionals able to provide EMA and most importantly gives women greater control over their bodies and treatment.

Interferon stimulated genes as peripheral diagnostic markers of early pregnancy in sheep: a critical assessment.

We investigated the diagnostic reliability of pregnancy detection using changes in interferon stimulated gene (ISG) messenger RNA (mRNA) levels in circulating immune cells in ewes. Two different groups of ewes (an experimental group, experiment 1 and a farm group, experiment 2) were oestrus-synchronized and blood sampled on day 14 (D0=day of insemination in control animals, experiment 1) and day 15 (experiment 2). Real-time PCR were performed to evaluate the abundance of different ISG mRNAs. In the experimental group, peripheral blood mononuclear cells of 29 ewes born and bred in experimental facilities were isolated using a Percoll gradient method. Gene expression for Chemokine (C-X-C motif) ligand 10 (CXCL10), Myxovirus (influenza virus) resistance 1 (MX1) and Signal transducer and activator of transcription 1 (STAT1) mRNA were, respectively, 8.3-fold, 6.1-fold and 2.7-fold higher (P0.10) in CXCL10, STAT1, MX1, Myxovirus (influenza virus) resistance 2 (MX2) and ISG15 ubiquitin-like modifier (ISG15) mRNA expression were found between pregnant and non-pregnant ewes. The ROC curves and the hierarchical classification generated from the real-time PCR data failed to discriminate between pregnant and non-pregnant animals. In this group of animals, our results show a strong variability in ISG expression patterns: 17% of animals identified as non-pregnant by the five tests were in fact pregnant, only 52% of pregnant animals had at least two positive results (two genes above threshold), whereas up to five positive results (five genes above threshold) were needed to avoid misclassification. In conclusion, this study illustrates the high variability in ISG expression levels in immune circulating cells during early pregnancy and, therefore, highlights the limits of using ISG expression levels in blood samples, collected on PAXgene® tubes on farms, for early pregnancy detection in sheep.

Non-invasive assessment of fecal progestagens and pregnancy detection in Himalayan musk deer (Moschus chrysogaster).

The Himalayan musk deer (Moschus chrysogaster), an endangered species, is facing threat of extinction globally due to severe hunting for its musk, and efforts are under way in India to breed them in captivity. However, no information is available on the reproductive cycles of the species. In this study, we aimed to standardize an enzyme immunoassay (EIA) procedure for monitoring pregnancy using fecal samples. We collected fecal samples for 12 months from five captive females maintained at the Musk Deer Research Centre, Bageshwar, Uttarakhand, India. Three of these females were observed mating and gave birth, whereas two were seen mating but did not give birth. The gestation periods for the three females were 183, 185, and 199 days, respectively. High-pressure liquid chromatography revealed the presence of immunoreactive pregnanediol-3-glucuronide (PdG), progesterone, and 5α-pregnan-3α-ol-20-one (5-alpha-pregnane) metabolites in the fecal samples. We used EIAs against progesterone, PdG, and 5-alpha-pregnane to monitor pregnancy. We found PdG EIA to be a highly accurate and sensitive assay compared with the other two assays in detecting pregnancy. We conclude that PdG EIA can be used to diagnose and monitor pregnancy in Himalayan musk deer using fecal steroid analysis, at an early stage of 3 months after mating. This study would help in conservation breeding of musk deer in captivity and in monitoring the reproductive status of the species in the wild.

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial.

BACKGROUND: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. METHODS: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. FINDINGS: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2·2%, 95% CI -5·9 to 1·6). One case of haemorrhage occurred in each group (rate of adverse events 0·3% in each group); no other adverse events were noted. INTERPRETATION: Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

Health consumption as work: the home pregnancy test as a domesticated health tool.

A growing array of biomedical goods and services has become central to the North American experience of navigating illness and pursuing good health. Yet despite the utility of consumption as an analytical framework within the social sciences, the selection, purchase, and use of biomedical goods and services has been understudied. By using the home pregnancy test as a case study, we suggest new approaches to thinking about the consumption of these goods and services. We chose the home pregnancy test because it is the best-known example of a mass-produced diagnostic tool used by consumers. We draw on two sources of data for this qualitative analysis: a set of stories submitted between 2003 and 2005 by women and men to an online exhibit mounted by the National Institutes of Health called "A Thin Blue Line: The History of the Pregnancy Test Kit," which we analysed between 2006 and 2007; and web sampling conducted in 2009 and 2010 of personal web and video logs of women and men who have posted stories and opinions about their experiences with contemporary home pregnancy testing products. We adapt the term "domestication" from Science and Technology Studies scholarship to describe the movement of diagnostic devices into homes for use by consumers. Specifically, we propose that the consumption of domesticated biomedical devices, goods, and services should be theorized as work performed by consumers, in two senses: as a form of tool use that allows non-experts to produce diagnostic knowledge about their own bodies and health; and as the ongoing biopolitical work that is expected of citizens to produce healthy bodies. Our paper draws attention to these understudied phenomena, while suggesting new approaches to theorizing the social and cultural elements of goods and services for health.

Home pregnancy test compared to standard-of-care ultrasound dating in the assessment of pregnancy duration.

OBJECTIVE: To determine the level of agreement between the Clearblue Digital Pregnancy Test with Conception Indicator home pregnancy test and standard-of-care ultrasound in assessing pregnancy duration in a real-life, observational setting encompassing routine, clinical care. RESEARCH DESIGN AND METHODS: This was a prospective observational study of non-pregnant women seeking conception. Women collected daily urine samples from day 1 of their next menstrual cycle. If any volunteer became pregnant, daily urine samples continued to be collected for 43 days after the LH surge. Samples from day -7 to day +28 relative to the expected period (LH surge + 15 days) were tested using the home pregnancy test. This categorised any resulting pregnancies into one of three groups: 1-2 weeks, 2-3 weeks, and 3+ weeks since conception. Information from the standard UK ultrasound dating scan was also recorded by the midwife, including the expected delivery date according to ultrasound and the expected delivery date according to LMP. MAIN OUTCOME MEASURES: Full data were available from 52 pregnant women who had conceived naturally. During the study analysis, 4786 urine samples were cross-compared with 52 routine 12-week NHS ultrasound assessments and the level of agreement between home pregnancy testing and standard-of-care ultrasound in determining pregnancy duration was calculated. RESULTS: The agreement between the gestational age as calculated by the home pregnancy test result and the exact midwife-recorded gestational age using ultrasound was 82.3%. However, when a ± 5-day range was applied to the ultrasound reading (as per routine UK clinical practice), the level of agreement was 98%. CONCLUSIONS: The home pregnancy test provides a significantly high (98%) level of agreement with standard-of-care ultrasound when assessing pregnancy duration in a real-life, observational setting which closely mirrors daily clinical practice.

Early pregnancy in adolescents: diagnosis, assessment, options counseling, and referral.

Health care providers are faced with many challenges when working with adolescents. Vague symptoms, unreliable menstrual history, and adolescent reluctance to disclose sexual activity present challenges to early diagnosis. When pregnancy is suspected, clinicians need skills for accurate diagnosis, conducting comprehensive assessments, and providing options counseling. Complexities of providing confidential care while balancing the needs of the adolescent and family may deter some clinicians. A clinical case scenario illustrates important elements of care. Through sharing lessons learned from 10 years of working in a Pregnancy Follow-up Clinic, the authors hope to empower other clinicians as they care for adolescents during this critical time.

Assessment of pregnancy in the late-gestation mare using digital infrared thermography.

The objective of this study was to investigate use of digital infrared thermal imaging (DITI) to determine whether surface temperature gradient differences exist between pregnant and nonpregnant mares as a noncontact method to determine pregnancy status. On the day measurements were collected, each pregnant mare (n=10; beginning at 292.4+/-1.4 d of gestation) was paired with a nonpregnant mare (n=17). Ambient temperature, DITI measurements (left and right flank, wither temperatures [i.e., animal surface control] and background temperature), and rectal temperatures were obtained every 7 d for 5 wk before parturition and for 3 wk after parturition. There were no differences (P>0.10) in temperature of the left and right side within groups; therefore, data were pooled. Pregnant mares had a higher (P<0.01) flank temperature than that of nonpregnant mares (36.0+/-0.2 degrees C vs. 34.2+/-0.2 degrees C, respectively). Moreover, the difference (2.4 degrees C) in flank temperatures between the pregnant and nonpregnant mares was greater when the ambient temperature was <19 degrees C. Flank and wither temperatures were positively correlated (R=0.72; P<0.01) and were positively correlated with ambient temperature (R=0.48 and 0.64, respectively; P<0.01). However, wither temperatures (skin control site) did not differ (P>0.10) between pregnant and nonpregnant mares. In conclusion, late-gestation mares had higher flank temperatures than those of nonpregnant mares, regardless of environmental conditions, however discriminating abilities were greater when ambient temperature was lower. We inferred that DITI may have value in confirming mid- to late-gestation pregnancies in some species by noncontact means, as observed in the mare.

Unintended vaccination of pregnant adolescents: estimating the scope of the problem and the impact of different pregnancy testing strategies.

Among a hypothetical cohort of 11-18-year-old females, we used a probabilistic decision tree model to estimate the number of pregnant adolescent females potentially receiving contraindicated vaccines during well child exams, and to determine the impact of two different pregnancy screening strategies on pregnancy detection rates, vaccine administration and pregnancy detection-associated costs. We found that under current practice conditions, the majority (95-99%) of adolescent pregnancies are likely missed during well child exams, allowing the opportunity to administer contraindicated vaccines. A strategy to test everyone detected the highest proportion of pregnancies, but at a substantial financial cost (USD 12,270,037-USD 19,430,607). Testing was more efficient for older adolescents, but both testing strategies were associated with a significant number of false positive test results (41-98%), regardless of age. These results suggest that systematic pregnancy screening strategies would be effective for preventing pregnant adolescents from receiving contraindicated vaccines, but may not be worth the potentially high financial and psychological costs.

[NPT (near patient test) in the pharmacy: document and practice guidelines 2008]. / Screening nelle farmacia: documento e linee guida 2008.

NPT tests in the pharmacy. Blood testing can be made with NPT (near patient testing) directly in the pharmacy. Most tests can be made with a single drop of blood (i.e. from a finger) and results are comparable with results from blood test obtained with standard vein blood samples. NPT is basically used for: 1 - evaluating the risk of a disease. 2 evaluating or confirming the presence of a disease. 3 to manage and monitor treatments. The social role of the pharmacy in NPT (particularly in cardiovascular screening) is very important as the pharmacy is an institution with capillary diffusion in the territory. The pharmacy often constitutes an important, first-level consultancy point for the population, particularly where health institutions are far away (small villages) or not easily accessible. Rules for NPT. Guidelines for NPT testing in the pharmacy have been proposed and discussed in a consensus meeting (Spoleto, 2007). NPT guidelines suggest operating management and technical procedures and indicate prospective lines of action defining new roles for the pharmacy. Coagulation tests can be now made in the pharmacy at a very low cost and with an efficacy comparable to blood tests obtained with a vein sample. Results can be read in seconds. This test is also available for personal use and home testing. NPT: The Clinical Study. The evaluation of the results of a clinical study (patients with venous thrombosis/pulmonary embolisation, patients with fibrillation and patients with artificial cardiac valves) indicates that costing is very favourable for NPT which may reduce costs and improve management of many clinical conditions and their monitoring. Training and control systems help NPT testing to be reliable and useful to screen and manage most clinical and risk conditions. The clinical study also shows the positive correlation between NPT tests and standard' tests. In conclusion NPT tests are now very reliable and cost-effective and can be used for screening, diagnosis and to monitor treatments.

Patient self assessment of pregnancy status in the emergency department.

OBJECTIVES: Pregnancy tests are often performed routinely for female emergency department (ED) patients of reproductive age. One major reason is a perception that patients are unreliable in predicting their own pregnancy status. We hypothesised that patients could reliably predict that they were not pregnant. METHODS: The study used a prospective cohort design, in an urban academic ED, from January 19 to May 19, 2004. All patients for whom a pregnancy test was ordered were asked about their sexual history as well as two additional questions: "Do you think you might be pregnant?" and "Is there any chance you could be pregnant?" Patients with already documented pregnancies were excluded. RESULTS: A total of 474 patients had pregnancy tests performed that met inclusion criteria. Eleven (2.3%) tests were positive. Among patients who answered no to both questions (337), one test (0.3%) was positive (negative predictive value (NPV) 99.7%, likelihood ratio (LR) 0.13 (95% CI, 0.02 to 0.82)). The other historical factor with a high NPV (100%) was not being sexually active (LR not calculable). All pregnancies occurred in patients with gastrointestinal or genitourinary as the chief complaint: this comprised only 56% of the presentations for which tests were ordered. CONCLUSION: Sexual history and self assessment can be used as a highly effective predictor of a patient not being pregnant. Given the risks of missed pregnancy in the ED, and low monetary and time cost of pregnancy tests, frequent testing is still recommended in most instances.

Inventions leading to the development of the diagnostic test kit industry--from the modern pregnancy test to the sandwich assays.

The universities are encouraged by the government nowadays to stimulate innovations and also to provide the proper machinery for assisting the protection and commercialisation of innovations. A better understanding of the innovation process may help to create an atmosphere suitable for inventions at the university. Examples can be taken from successful innovations previously made at the university. During the 1960's I made a series of inventions, which ultimately led to the development of the diagnostic test kit industry. The first, which I made as an undergraduate, was a simple and reliable test kit for diagnosis of pregnancy. This was followed by the solid phase radioimmunoassay and a solid phase assay for vitamin B12; next, the dual specific non-competitive sandwich assay and the in-vitro test for diagnosis of allergy, called RAST (Radioallergosorbent test). Organon in Holland with the pregnancy test kit, and Pharmacia in Sweden with test kits for radioimmunoassay, became pioneers among the diagnostic test kit industries. Pharmacia Diagnostics later became one of the leading diagnostic test kit companies in the world and has continued to be so in the field of allergy diagnosis. Each one of these inventions started with a few unique observations leading to a technical development. The pregnancy test as well as the allergy test emerged from the development of assay methods with unique qualities with the subsequent search for appropriate applications. The foreseeing of a commercial value on a future market was a very important step. This was followed by the search for a suitable industry interested to exploit the invention with its new business opportunity i.e. apply for a patent, produce and market the products, which in my case consisted of the necessary reagents and equipments for particular diagnostic tests. Finally, an agreement had to be settled between the entrepreneur and the inventors. This report describes these inventions and particularly discusses some crucial steps of the innovation processes.

Urinary-based ovulation and pregnancy: point-of-care testing.

OBJECTIVE: To review the literature concerning ovulation prediction devices and pregnancy detection tests for home use. DATA SOURCES: Articles were identified through searches of the MEDLINE (1966-May 2003), EMBASE (1980-May 2003), and International Pharmaceutical Abstracts (1970-May 2003) databases using the key words ovulation, ovulation detection, pregnancy test, diagnostic reagent kit, and diagnostic test. Additional references were located through review of the bibliographies of the articles found in the literature search. Searches were not limited by time restriction, language, or use of human or animal subjects. STUDY SELECTION AND DATA EXTRACTION: Review articles, textbook chapters, and experimental and observational studies on home use ovulation and pregnancy tests were selected. DATA SYNTHESIS: Luteinizing hormone (LH)-based ovulation tests have demonstrated accurate and superior ovulation detection when compared to basal body temperature charting, calendar calculation, salivary ferning, or observation of vaginal or cervical discharge changes. Systems using LH and estrone-3-glucuronide (E3G) have also demonstrated accurate detection of the fertile period. Literature evaluating home use of pregnancy tests has demonstrated accurate use by lay persons. CONCLUSIONS: Urinary-based ovulation prediction and pregnancy detection tests available for use by nonprofessionals enable women and couples to take an active role in the family planning process. Numerous products are available at reasonable costs to the consumer.

When the test really counts: part one: earliest pregnancy detection.

We tested 18 pregnancy-test kits to find out which brands work best. Buy the top performers and follow our tips for the most accurate results.

Use of an automated database to evaluate markers for early detection of pregnancy.

The objective of this study was to develop and validate algorithms to detect pregnancies from the time of first clinical recognition by using Kaiser Permanente automated databases from Portland, Oregon. In 1993--1994, the authors evaluated these databases retrospectively to identify markers indicative of initial clinical detection of pregnancy and pregnancy outcomes. Pregnancy markers were found for 99% of the women for whom pregnancy outcomes were included in the automated databases, and pregnancy outcomes were identified for 77% of the women for whom there were pregnancy markers. The earliest marker most predictive of a pregnancy outcome was a positive human chorionic gonadotropin test; least predictive was an obstetric outpatient visit. Medical record review indicated that in a sample of women with pregnancy markers in the database, an estimated 6% of pregnancy outcomes (primarily early fetal deaths and elective terminations) were lost. Pregnancies were first captured in automated databases 6--8 weeks after the last menstrual period, and a combination of a positive human chorionic gonadotropin test and an outpatient obstetric visit was the most sensitive and specific early marker of pregnancy. When combined with automated pharmacy records, these databases may be valuable tools for evaluating prescription drug effects on all major outcomes of clinically recognized pregnancies.

Advances in ultrasound assessment in the establishment and development of pregnancy.

Current data demonstrate that angiogenesis in the ovaries and uterus is an essential component of both follicular and luteal phases of menstrual cycle, tightly correlating with the levels of bioactive substances such as hormones, growth factors and interleukins. Ultrasound is used principally to demonstrate follicular growth, a receptive triple layer endometrium and to exclude pathologies such as fibroids and ovarian tumours. However, the development of new technologies such as CDI, CPA, 3D-US, 3D-CPA is now set to expand the role of ultrasound in the assessment of the processes in the ovaries, uterus and early pregnancy. There is growing evidence that studies of peri-follicular vascularity will predict the development of a healthy oocyte and subsequently an embryo. Endometrial blood flow studies with conventional CDI and the newer techniques of CPA and 3D-CPA will be important in predicting endometrial receptivity. Ovarian stromal vascularity appears to correlate with vascular endothelial growth factor (VEGF) levels and high vascularity is associated with PCO and a risk of ovarian hyperstimulation syndrome. 3D-CPA may improve our ability to assess ovarian and endometrial vascularization and blood circulation, to diagnose tubal patency. Increasingly, 3D ultrasound is being applied to diagnose the pathology of early singleton and multiple pregnancies.

Home and laboratory pregnancy-testing kits.

Home pregnancy test kits are more sensitive than many pregnancy kits used in laboratories or health centres. Nurses should know the sensitivity of the kit used in their centre or laboratory. A positive home pregnancy test should always be treated as the correct result until sufficient tests have been carried out to prove otherwise.

Evaluation of the benefits of the timing of pregnancy testing by transrectal palpation in dairy cattle.

OBJECTIVE: To determine the benefits that were associated with pregnancy testing by use of transrectal palpation during the period 30 to 65 days after unsuccessful insemination of dairy cows. DESIGN: Nonconcurrent, cohort study. ANIMALS: Cows in 15 dairy herds in the United States and Canada. PROCEDURE: Reproductive records of cows (n = 713) that did not calve within 294 days of first-service insemination and that had been evaluated for pregnancy 30 to 65 days after first-service insemination were examined. Records were analyzed to determine the day of parturition or date of culling and to determine if the probability of a cow being culled or the interval to parturition was related to the number of days after insemination that pregnancy testing was performed. RESULTS: For cows that calved more than 294 days after first-service insemination, the interval from first-service insemination until parturition was associated significantly with herd, season, and treatment on the day of pregnancy testing with prostaglandin F2 alpha or one of its analogues. Cows treated with prostaglandin F2 alpha on the day of pregnancy testing were less likely to be culled than nontreated cows. For cows pregnancy tested 30 to 65 days after insemination, each additional day after day 30 before pregnancy testing was performed resulted in an increase of 1.09 days in the interval until parturition. CLINICAL IMPLICATIONS: Pregnancy testing by means of transrectal palpation as soon as possible after day 30 after insemination can result in shorter calving intervals.

Assessment of four enzyme immunoassay kits for serum beta-hCG screening.

This pilot study evaluates four qualitative serum beta-human chorionic gonadotropin (beta-hCG) enzyme immunoassay kits for both routine pregnancy testing and screening for ectopic pregnancy. We found that the Tandem-E HCG assay had the lowest limit of detection, and longest turnaround time. Tandem ICON HCG assay had the shortest turnaround time. The Vis-Con II was the most economical batch test. The Quest assay kit was both fast and simple and had the lowest cost for stat testing.

Selected serology: pregnancy testing, hepatitis A and B, and infectious mononucleosis.

The basic principles of serologic testing are discussed in this article. Specific emphasis is placed on pregnancy tests, hepatitis serology, and infectious mononucleosis testing. Indications for emergency department use are elucidated.