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1.
Clin Trials ; 17(3): 314-322, 2020 06.
Article in English | MEDLINE | ID: mdl-32026710

ABSTRACT

BACKGROUND/AIMS: The Clinical Trials Coordination and Facilitation Group has issued recommendations on contraception and pregnancy testing to help sponsors meet regulatory expectations and harmonize practices to limit embryofetal risks in clinical trials. Our objective was to assess the compliance of French academic clinical trials with these recommendations and to describe the mitigation measures required by sponsors in their trials. METHODS: A cross-sectional study was performed on the French academic drug trials authorized by the national competent authority between January 2015 and June 2018. We included trials which tested systemic administration of drugs and enrolled men or women of childbearing potential. RESULTS: Data from 97 trials included were compiled. One-third of the trials (23.8%-43.3%, 95% confidence interval) complied with the Clinical Trial Facilitation and Coordination Group recommendations. No improvement over time or according to embryofetotoxic status or drug duration exposure was found. Contraception was required in 56.7% of trials and was more often required in case of potentially embryofetotoxic drugs (68.5% vs 41.9%, p = 0.013) or exposure over 1 month (71.7% vs 43.8%, p = 0.006). Pregnancy testing at inclusion was required in 59.1% of trials and additional testing in 17.2%. Pregnancy testing at inclusion was more often required in trials with drug exposure above 1 month (67.4% vs 45.8%, p = 0.035). CONCLUSION: French academic sponsors barely met the recommendations on contraception and pregnancy testing potentially leading to potential embryofetal risks in case of pregnancy. They need to implement these recommendations quickly.


Subject(s)
Clinical Trials as Topic/methods , Contraception/statistics & numerical data , Guideline Adherence/statistics & numerical data , Pregnancy Tests/statistics & numerical data , Adult , Cross-Sectional Studies , Female , France , Humans , Male , Practice Guidelines as Topic , Pregnancy
2.
Health Policy Plan ; 34(8): 566-573, 2019 Oct 01.
Article in English | MEDLINE | ID: mdl-31408150

ABSTRACT

Task-shifting the provision of pregnancy tests to community health workers (CHWs) in low-resource settings has the potential to reach significantly more underserved women at risk of pregnancy with essential reproductive health services. This study assessed whether an intervention to supply CHWs with home pregnancy tests brought more clients for antenatal care (ANC) counselling. We implemented a randomized controlled trial among CHWs providing reproductive health services to women in Eastern Madagascar. We used ordinary least squares regressions to estimate the effect of the intervention, with district- and month-fixed effects and CHW baseline characteristics as control variables. Our outcomes of interest included whether the intervention increased: (1) the number of women at risk of pregnancy who sought services from CHWs; (2) the number of these women who knew they were pregnant by the end of visit; and (3) the number of these women who received ANC counselling during visit. We found that providing pregnancy tests to CHWs to distribute to their clients for free significantly increased the number of women at risk of pregnancy who sought services from CHWs. At follow-up, treatment-group CHWs provided services to 6.3 clients compared with 4.2 clients among control-group CHWs, which represents a 50% relative increase from the control-group mean. A significantly higher number of these clients knew they were pregnant by the end of the visit, with a mean of 0.95 in treatment compared with 0.10 in control (Coeff. 0.86; 95% CI 0.59-1.13). A significantly higher number of these clients received antenatal counselling at the visit (Coeff. 0.4; 95% CI 0.14-0.64). Introducing free home pregnancy tests as part of community-based health services can improve pregnancy care by attracting more clients at risk of pregnancy to services at the community level, enabling more women to confirm they are pregnant and receive antenatal counselling.


Subject(s)
Community Health Workers/organization & administration , Pregnancy Tests/economics , Prenatal Care/statistics & numerical data , Adult , Counseling/statistics & numerical data , Female , Humans , Madagascar , Male , Middle Aged , Pregnancy , Pregnancy Tests/statistics & numerical data
3.
Eur J Contracept Reprod Health Care ; 23(3): 179-182, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29764233

ABSTRACT

BACKGROUND: Performance of urine pregnancy test in general adolescents' clinic reflects caregiver or woman's concern that there might be a pregnancy. We aimed to assess whether young-unmarried women in whom a negative urine pregnancy test was registered would be at increased risk of a future unintended pregnancy. METHODS: The study cohort included consecutive women drafted by the Israeli military between 2013 and 2015. The risk of unintended pregnancy was compared between women with a negative urine pregnancy test (n = 2774), the study group, and those in whom urine pregnancy test was not carried out (n = 126,659), the control group. RESULTS: During the study period, 2147 (1.7%) women experienced an unintended pregnancy. The risk of unintended pregnancy was significantly higher in patients in whom a past pregnancy test was negative 4.3% (n = 118), as compared with the control group 1.6% (n = 2028) (odds ratio [OR], 2.7; 95% confidence interval [CI], 2.23-3.26). In multivariate analysis history of a negative pregnancy test results was an independent predictor for a future unintended pregnancy (adjusted OR, 2.0; 95% CI, 1.63-2.52). CONCLUSIONS: A history of a negative pregnancy test among young conscripted women is a significant risk indicator for a future unintended pregnancy. Directed efforts should be made in this particular vulnerable group of patients.


Subject(s)
Pregnancy Tests/statistics & numerical data , Pregnancy, Unplanned , Adolescent , Female , Health Status , Humans , Israel , Military Personnel , Pregnancy , Risk Factors , Socioeconomic Factors , Young Adult
4.
Scott Med J ; 63(2): 60-62, 2018 May.
Article in English | MEDLINE | ID: mdl-29514585

ABSTRACT

We report a case of a young woman admitted electively for laparoscopic Nissen fundoplication, and again three days post-operatively as an emergency with profuse vomiting and abdominal pain. She underwent diagnostic laparoscopy, and a small gastric perforation was found at the site of the fundoplication and this was suture-repaired. On both admissions, she was "screened" for pregnancy as per current guidelines. On the second admission, following a CT scan, she was found to have a gravid uterus with a foetus of 16-18 weeks' gestation. In the opinion of the authors, this case highlights that current National Institute for Health and Care Excellence guidelines may be insufficient and could lead to unnecessary harm either to mother or foetus pre-, peri- or post-operatively.


Subject(s)
Fundoplication , Laparoscopy , Polycystic Ovary Syndrome/surgery , Pregnancy Tests , Preoperative Care , Abdominal Pain , Adult , Female , Humans , Pregnancy , Pregnancy Outcome , Pregnancy Tests/statistics & numerical data , Pregnancy, Unplanned , Risk Factors
5.
Health (London) ; 22(1): 87-105, 2018 01.
Article in English | MEDLINE | ID: mdl-29090634

ABSTRACT

Upon their availability for purchase in the 1970s, home pregnancy testing devices were hailed as a 'revolution' for women's reproductive rights. Some authors, however, have described these technologies as further enabling the medicalisation of pregnancy and as contributing to the devaluing of women's embodied knowledge. The home pregnancy test is one of many technological devices encountered by women experiencing pregnancy in the United Kingdom today. Existing literature has described how engagement with medical technologies during pregnancy might address uncertainties experienced at this time, providing women with reassurance and alleviating anxieties. Drawing on interviews with women living in Scotland, this article explores accounts of testing for a first pregnancy, and women's descriptions of the impacts of home pregnancy testing upon experiences of early gestation. Participants engaged with pregnancy tests in varying ways, with uses shaping and shaped by their experiences of early pregnancy more broadly. Particular technical characteristics of the home pregnancy test led many participants to question their interpretation of a positive result, as well as the accuracy of the test itself. Rather than addressing the unknowns of early gestation by confirming a suspected pregnancy, a positive result could thus exacerbate uncertainty. Through participants' accounts, this article shows how uncertainty is lived out by users of mundane techno-medical artefacts and sheds new light on women's experiences of the first trimester of pregnancy.


Subject(s)
Pregnancy Tests/statistics & numerical data , Uncertainty , Women's Health , Adult , Female , Humans , Interviews as Topic , Pregnancy , Qualitative Research , United Kingdom
6.
Intern Med J ; 46(10): 1222-1224, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27734613

ABSTRACT

A retrospective case notes review was performed to determine compliance with screening for undetected pregnancy prior to commencement of chemotherapy at Flinders Medical Centre. All female patients aged 18-55 who commenced chemotherapy between January and December 2014 were included. During the first 12 months, for women identified as having childbearing potential, pre-chemotherapy pregnancy screening was performed only in 40% of patients under 40 years and in 20.5% of the entire age range.


Subject(s)
Neoplasms/drug therapy , Pregnancy Tests/statistics & numerical data , Adolescent , Adult , Australia , Chorionic Gonadotropin, beta Subunit, Human/blood , Drug Therapy , Female , Humans , Middle Aged , Neoplasms/blood , Pregnancy , Retrospective Studies , Young Adult
7.
Cancer ; 122(21): 3394-3400, 2016 Nov 15.
Article in English | MEDLINE | ID: mdl-27618636

ABSTRACT

BACKGROUND: Adolescents with cancer engage in sexual behaviors and are exposed to teratogenic chemotherapy. There are no data regarding pregnancy screening patterns for adolescents before chemotherapy exposure. METHODS: A cross-sectional study of leukemia and emergency room (ER) admissions in the Pediatric Health Information System from 1999 to 2011 was conducted. Females who were 10 to 18 years old and 1) had newly diagnosed acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) or 2) had ER visits with computed tomography (CT) of the abdomen/pelvis were included. The exposure was a hospital visit with either chemotherapy or an abdominal/pelvic CT scan. The main outcome was a pregnancy test billed on the same day or before the teratogenic exposure within the same index admission. Log-binomial regressions were used to compute prevalence ratios and 95% confidence intervals comparing pregnancy screening in the leukemia and ER cohorts. RESULTS: A total of 35,650 admissions were identified. The proportion of visits with an appropriately timed pregnancy test was 35%, 64%, and 58% in the ALL (n = 889), AML (n = 127), and ER cohorts (n = 34,634), respectively. Patients with ALL were significantly less likely to have a pregnancy test than the ER cohort (adjusted prevalence ratio, 0.71; 95% confidence interval, 0.65-0.78), but there was no significant difference between the AML and ER cohorts (adjusted prevalence ratio, 1.12; 95% confidence interval, 0.99-1.27). There was substantial hospital-level variation in pregnancy screening patterns. CONCLUSIONS: Adolescents with acute leukemia and ER visits have low rates of pregnancy screening before teratogenic exposures. Standardized practice guidelines for pregnancy screening among adolescents may improve screening rates. Cancer 2016;122:3394-3400. © 2016 American Cancer Society.


Subject(s)
Environmental Exposure/adverse effects , Hospitals, Pediatric , Leukemia, Myeloid, Acute/complications , Precursor Cell Lymphoblastic Leukemia-Lymphoma/complications , Pregnancy Tests/statistics & numerical data , Pregnancy in Adolescence/drug effects , Teratogens/pharmacology , Abnormalities, Drug-Induced/etiology , Abnormalities, Drug-Induced/pathology , Adolescent , Child , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/pathology , Emergency Service, Hospital , Female , Follow-Up Studies , Hospitalization , Humans , Leukemia, Myeloid, Acute/pathology , Precursor Cell Lymphoblastic Leukemia-Lymphoma/pathology , Pregnancy , Pregnancy Complications/etiology , Prognosis , Risk Factors
8.
J Obstet Gynaecol ; 36(4): 437-9, 2016 May.
Article in English | MEDLINE | ID: mdl-27002651

ABSTRACT

This retrospective cohort study reviewed the diagnosis of all ectopic pregnancies within a district general hospital over a 5-year period after the establishment of a dedicated Early Pregnancy Assessment Unit (EPAU). Of 215 ectopic pregnancies identified, notes were available for 208 (97%). Two-hundred and two cases were determined to have been diagnosed and managed as ectopic pregnancies. Six cases were excluded as they were pregnancies of unknown location managed as such. Overall, 91% were diagnosed by ultrasound scan, 5% were diagnosed clinically and 3% were diagnosed on serial human chorionic gonadotrophin (hCG) levels. This study found that the introduction of a dedicated, multi-professional, EPAU with a stable workforce improved ultrasound visualisation of ectopic pregnancies at first ultrasound scan from 22% prior to its commencement, to 61% over this period. The improvement in positive scan diagnosis of ectopic pregnancy was associated with a reduction in negative laparoscopy rate from 13% to 6%.


Subject(s)
Pregnancy Tests/statistics & numerical data , Pregnancy, Ectopic/diagnostic imaging , Ultrasonography, Prenatal/statistics & numerical data , Adolescent , Adult , Chorionic Gonadotropin, beta Subunit, Human , False Positive Reactions , Female , Humans , Middle Aged , Pregnancy , Pregnancy Tests/methods , Reproducibility of Results , Retrospective Studies , Young Adult
9.
Pediatrics ; 136(6): e1495-503, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26527554

ABSTRACT

OBJECTIVE: To examine rates of recommended of testing and prophylaxis for chlamydia, gonorrhea, and pregnancy in adolescents diagnosed with sexual assault across pediatric emergency departments (EDs) and to determine whether specialized sexual assault pathways and teams are associated with performance of recommended testing and prophylaxis. METHODS: In this retrospective study of 12- to 18-year-old adolescents diagnosed with sexual assault at 38 EDs in the Pediatric Hospital Information System database from 2004 to 2013, information regarding routine practice for sexual assault evaluations and presence and year of initiation of specialized ED sexual assault pathways and teams was collected via survey. We examined across-hospital variation and identified patient- and hospital-level factors associated with testing and prophylaxis using logistic regression models, accounting for clustering by hospital. RESULTS: Among 12,687 included cases, 93% were female, 79% were <16 years old, 34% were non-Hispanic white, 38% were non-Hispanic black, 21% were Hispanic, and 52% had public insurance. Overall, 44% of adolescents received recommended testing (chlamydia, gonorrhea, pregnancy) and 35% received recommended prophylaxis (chlamydia, gonorrhea, emergency contraception). Across EDs, unadjusted rates of testing ranged from 6% to 89%, and prophylaxis ranged from 0% to 57%. Presence of a specialized sexual assault pathway was associated with increased rates of prophylaxis even after adjusting for case-mix and temporal trends (odds ratio 1.46, 95% confidence interval 1.15 to 1.86). CONCLUSIONS: Evaluation and treatment of adolescent sexual assault victims varied widely across pediatric EDs. Adolescents cared for in EDs with specialized sexual assault pathways were more likely to receive recommended prophylaxis.


Subject(s)
Child Abuse, Sexual , Emergency Service, Hospital/statistics & numerical data , Guideline Adherence/statistics & numerical data , Healthcare Disparities/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Rape , Adolescent , Child , Child Abuse, Sexual/diagnosis , Child Abuse, Sexual/statistics & numerical data , Chlamydia Infections/diagnosis , Chlamydia Infections/prevention & control , Chlamydia Infections/transmission , Contraception, Postcoital/statistics & numerical data , Critical Pathways/statistics & numerical data , Databases, Factual , Emergency Service, Hospital/organization & administration , Female , Gonorrhea/diagnosis , Gonorrhea/prevention & control , Gonorrhea/transmission , Humans , Male , Practice Guidelines as Topic , Pregnancy , Pregnancy Tests/statistics & numerical data , Rape/diagnosis , Rape/statistics & numerical data , Retrospective Studies , United States
12.
Acad Emerg Med ; 22(2): 192-6, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25639672

ABSTRACT

OBJECTIVES: The objectives were to estimate the frequency of pregnancy testing in emergency department (ED) visits by reproductive-aged women administered or prescribed teratogenic medications (Food and Drug Administration categories D or X) and to determine factors associated with nonreceipt of a pregnancy test. METHODS: This was a retrospective cross-sectional study using 2005 through 2009 National Hospital Ambulatory Medical Care Survey data of ED visits by females ages 14 to 40 years. The number of visits was estimated where teratogenic medications were administered or prescribed and pregnancy testing was not conducted. The association of demographic and clinical factors with nonreceipt of pregnancy testing was assessed using multivariable logistic regression. RESULTS: Of 39,859 sampled visits, representing an estimated 141.0 million ED visits by reproductive-aged females nationwide, 10.1 million (95% confidence interval [CI] = 8.9 to 11.3 million) estimated visits were associated with administration or prescription of teratogenic medications. Of these, 22.0% (95% CI = 19.8% to 24.2%) underwent pregnancy testing. The most frequent teratogenic medications administered without pregnancy testing were benzodiazepines (52.2%; 95% CI = 31.1% to 72.7%), antibiotics (10.7%; 95% CI = 5.0% to 16.3%), and antiepileptics (7.7%; 95% CI = 0.12% to 15.5%). The most common diagnoses associated with teratogenic drug prescription without pregnancy testing were psychiatric (16.1%; 95% CI = 13.6% to 18.6%), musculoskeletal (12.7%; 95% CI = 10.8% to 14.5%), and cardiac (9.5%; 95% CI = 7.6% to 11.3%). In multivariable analyses, visits by older (adjusted odds ratio [AOR] = 0.57, 95% CI = 0.42 to 0.79), non-Hispanic white females (AOR = 0.71; 95% CI = 0.54 to 0.93); visits in the Northeast region (AOR = 0.60; 95% CI = 0.42 to 0.86); and visits during which teratogenic medications were administered in the ED only (AOR = 0.74; 95% CI = 0.57 to 0.97) compared to prescribed at discharge only were less likely to have pregnancy testing. CONCLUSIONS: A minority of ED visits by reproductive-aged women included pregnancy testing when patients were prescribed category D or X medications. Interventions are needed to ensure that pregnancy testing occurs before women are prescribed potentially teratogenic medications, as a preventable cause of infant morbidity.


Subject(s)
Emergency Service, Hospital/statistics & numerical data , Pregnancy Tests/statistics & numerical data , Prescription Drugs , Teratogens , Adolescent , Adult , Cross-Sectional Studies , Female , Health Care Surveys , Humans , Logistic Models , Odds Ratio , Pregnancy , Residence Characteristics , Retrospective Studies , United States , Young Adult
13.
Contraception ; 89(5): 400-6, 2014 May.
Article in English | MEDLINE | ID: mdl-24636226

ABSTRACT

BACKGROUND: Delayed pregnancy testing has been associated with presentation for abortion in the second trimester. Little is known about acceptability of potential interventions to hasten pregnancy recognition. STUDY DESIGN: A total of 592 women presenting for abortion at six clinics in the United States completed surveys on contraceptive use, risk behavior, timing of first pregnancy test and interest in interventions to speed pregnancy recognition and testing. RESULTS: Forty-eight percent of women presenting for second-trimester abortion delayed testing until at least 8 weeks. In multivariate analysis, women who often spotted between periods had higher odds of delaying pregnancy testing [odds ratio (OR) 2.7, 95% confidence interval (CI) 1.04-6.94]. Women who often missed periods had higher odds of second-trimester abortion (OR 2.1, 95% CI 1.34-3.13). The majority (64%) of women were not aware of a fertile time in the menstrual cycle; these women had higher odds of second-trimester abortion (OR 2.0, 95% CI 1.21-3.37). Ninety-four percent of women expressed interest in at least one potential intervention to help recognize pregnancy earlier. CONCLUSIONS: While there was near-universal interest in earlier pregnancy recognition, no single proposed intervention or scenario was endorsed by the majority. Improving sexual health awareness is an important consideration in future efforts to expedite pregnancy testing. IMPLICATIONS: We found near-universal interest in earlier pregnancy recognition, though no single proposed intervention or scenario garnered majority support. Based on our findings, the concept of improving sexual health awareness through education should be incorporated in the development of future strategies to hasten recognition of unintended pregnancy.


Subject(s)
Abortion, Induced/statistics & numerical data , Health Knowledge, Attitudes, Practice , Pregnancy Tests/statistics & numerical data , Pregnancy Trimester, Second , Pregnancy, Unwanted , Adult , Cross-Sectional Studies , Female , Humans , Pregnancy , Young Adult
15.
J Matern Fetal Neonatal Med ; 27(12): 1204-8, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24168054

ABSTRACT

OBJECTIVES: To estimate the proportion of women in early pregnancy prescribed potentially feto-toxic medications at an out-patient clinic in Malawi. METHODS: Over six-months the number of women of child-bearing age attending out-patient clinics and prescribed medicines at Mitundu Community Hospital was derived from the hospital's registry and pharmacy records. Women prescribed potentially feto-toxic medicines (using Food and Drug Administration classifications) by medical assessments were subsequently interviewed and pregnancy tested. Exposure to potentially feto-toxic medications was estimated and differences between pregnant and non-pregnant women were described. RESULTS: Of 8970 female outpatients, 1012 (11.3%; 95% CI: 10.6% to 12%) were prescribed potentially feto-toxic medicines. After excluding 740 as unlikely to be pregnant, 209 women had negative pregnancy tests and 63 were confirmed as pregnant, representing one in 16 of women prescribed contraindicated medicines or between 2.8% and 3.5% of all women attending in early pregnancy. Most medicines were FDA rated C or D. Only 152 (55.9%) of these women had been asked about pregnancy and prescribing practices did not discriminate between pregnant and non-pregnant patients. CONCLUSIONS: Assessment and prescribing practices for women attending out-patient clinics who might be in early pregnancy were inadequate, increasing the risk of exposure to potentially feto-toxic medicines.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Fetal Diseases/chemically induced , Fetal Diseases/epidemiology , Prenatal Exposure Delayed Effects/epidemiology , Abnormalities, Drug-Induced/epidemiology , Adult , Contraindications , Drug Prescriptions/statistics & numerical data , Female , Gestational Age , Humans , Malawi/epidemiology , Outpatients/statistics & numerical data , Pharmaceutical Preparations/classification , Pregnancy , Pregnancy Tests/statistics & numerical data , Pregnancy Trimester, First , Teratogens , Young Adult
16.
J Gynecol Obstet Biol Reprod (Paris) ; 42(8): 1032-49, 2013 Dec.
Article in French | MEDLINE | ID: mdl-24210234

ABSTRACT

OBJECTIVE: To provide clinical practice guidelines (CPGs) from the French college of obstetrics and gynecology (CNGOF), based on the best evidence available, concerning the adverse events related to hysteroscopy. MATERIALS AND METHODS: Review of literature using following Keywords: hysteroscopy; vaginoscopy; infection; perforation; intrauterine adhesions RESULTS: Vaginoscopy should be the standard technique for outpatient hysteroscopy (grade A) using a miniature (≤ 3.5mm sheath) (grade A) rigid hysteroscope (grade C), using normal saline solution distension medium (grade C), without any anesthesia (conscious sedation should not be routinely used), without cervical preparation (grade B), without vaginal disinfection and without antibiotic prophylaxy (grade B). Misoprostol (grade A), vaginal estrogens (grade C), or GnRH agonist routine administration is not recommended before operative hysteroscopy. Before performing hysteroscopy, it is important to purge the air out of the system (grade A). The uterine cavity distention pressure should be maintained below the mean arterial pressure and below 120 mmHg. The maximum fluid deficit of 2000 mL is suggested when using normal saline solution and 1000 mL is suggested when using hypotonic solution. When uterine perforation is recognized during operative hysteroscopy using monopolar or bipolar loop, the procedure should be stopped and a laparoscopy should be performed in order to eliminate a bowel injury. Diagnostic or operative hysteroscopy is allowed when an endometrial cancer is suspected (grade B). CONCLUSION: Implementation of this guideline should decrease the prevalence of complications related to office and operative hysteroscopy.


Subject(s)
Hysteroscopy/adverse effects , Hysteroscopy/standards , Postoperative Complications/prevention & control , Practice Guidelines as Topic , Diagnostic Techniques, Obstetrical and Gynecological/standards , Diagnostic Techniques, Obstetrical and Gynecological/statistics & numerical data , Female , Humans , Hysteroscopy/statistics & numerical data , Postoperative Complications/epidemiology , Pregnancy , Pregnancy Tests/statistics & numerical data , Professional Practice/standards , Uterine Diseases/diagnosis , Uterine Diseases/epidemiology
17.
Arq. bras. cardiol ; 101(5): 418-422, nov. 2013. tab
Article in Portuguese | LILACS | ID: lil-696889

ABSTRACT

FUNDAMENTO: A Comissão Internacional de Radiologia indica rastreamento com teste de gravidez a todas pacientes do gênero feminino em período fértil que serão submetidas a exame radiológico. Sabe-se que a radiação é teratogênica e que seu efeito é cumulativo. O potencial teratogênico inicia-se com doses próximas às das utilizadas durante esses procedimentos. Não se sabe a prevalência de teste de gravidez positivo em pacientes submetidos a estudo eletrofisiológico e/ou à ablação por cateter em nosso meio. OBJETIVO: Avaliar a prevalência de teste de gravidez positivo em pacientes do gênero feminino encaminhadas para estudo eletrofisiológico e/ou ablação por radiofrequência. MÉTODOS: Estudo transversal com análise de 2.966 pacientes submetidos a estudo eletrofisiológico e/ou ablação por cateter, de junho 1997 a fevereiro 2013, no Instituto de Cardiologia do Rio Grande do Sul. Foram realizados 1.490 exames em mulheres sendo que, destas, 769 encontravam-se em idade fértil. Todas as pacientes foram rastreadas com teste de gravidez no dia anterior ao procedimento. RESULTADOS: Detectou-se positividade do teste em três pacientes, impossibilitando a realização do exame. Observou-se prevalência de 3,9 casos por 1.000 mulheres em idade fértil. CONCLUSÃO: Devido ao baixo custo e à segurança, indica-se a realização de teste de rastreamento para gravidez a todas pacientes em idade fértil, uma vez que o grau de radiação ionizante necessária nesse procedimento é muito próximo ao limiar de teratogenicidade, principalmente no primeiro trimestre, quando os sinais de gestação não são exuberantes.


BACKGROUND: The International Commission of Radiology recommends a pregnancy screening test to all female patients of childbearing age who will undergo a radiological study. Radiation is known to be teratogenic and its effect is cumulative. The teratogenic potential starts at doses close to those used during these procedures. The prevalence of positive pregnancy tests in patients undergoing electrophysiological studies and/or catheter ablation in our midst is unknown. OBJECTIVE: To evaluate the prevalence of positive pregnancy tests in female patients referred for electrophysiological study and/or radiofrequency ablation. METHODS: Cross-sectional study analyzing 2966 patients undergoing electrophysiological study and/or catheter ablation, from June 1997 to February 2013, in the Institute of Cardiology of Rio Grande do Sul. A total of 1490 procedures were performed in women, of whom 769 were of childbearing age. All patients were screened with a pregnancy test on the day before the procedure. RESULTS: Three patients tested positive, and were therefore unable to undergo the procedure. The prevalence observed was 3.9 cases per 1000 women of childbearing age. CONCLUSION: Because of their safety and low cost, pregnancy screening tests are indicated for all women of childbearing age undergoing radiological studies, since the degree of ionizing radiation needed for these procedures is very close to the threshold for teratogenicity, especially in the first trimester, when the signs of pregnancy are not evident.


Subject(s)
Adult , Female , Humans , Pregnancy , Young Adult , Abnormalities, Radiation-Induced/prevention & control , Catheter Ablation/adverse effects , Fetal Development/radiation effects , Pregnancy Tests/statistics & numerical data , Age Factors , Cross-Sectional Studies , Pregnancy Trimester, First , Prevalence , Risk Assessment
18.
Fertil Steril ; 100(6): 1635-41.e1, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24074759

ABSTRACT

OBJECTIVE: To assess a home pregnancy test's accuracy to concurrently detect pregnancy and determine pregnancy duration. DESIGN: Multicenter, prospective study. SETTING: Study sites in the United States. PATIENT(S): Women actively attempting to conceive who have menstrual bleeds (18-45 years). INTERVENTION(S): Volunteers collected early morning urine samples (three or fewer menstrual cycles). Pregnant volunteers underwent ultrasound dating scans. Ovulation day (LH surge +1 day) during pregnancy-resulting cycles was determined by quantitative measurement of LH. Random urine samples were tested with the hCG-measuring pregnancy test from 4 days before the expected period until 4 weeks later. MAIN OUTCOME MEASURE(S): A home pregnancy test's accuracy in determining pregnancy duration compared with ultrasound and ovulation day. RESULT(S): Agreement between pregnancy test results and time since ovulation was 93% (confidence interval [CI], 91.5-94.4). Agreement with ultrasound was dependent on the formula: there was 99% agreement when calculated with adjustment for Hadlock formula bias (Pexsters; CI, 98.2-99.4) or using a nonbias formula (Wu; CI, 98.6-99.6), when ultrasound error was accommodated. Agreement was lower when bias/measurement errors were not accounted for (Wu, 86%, CI, 83.9-88; Hadlock, 80.8, CI, 78.2-83.3). CONCLUSION(S): This home pregnancy test provides an accurate estimation of pregnancy duration in weeks categories, 1-2, 2-3, 3+ weeks since ovulation, thereby showing utility in dating pregnancy.


Subject(s)
Ovulation Detection/instrumentation , Ovulation Detection/statistics & numerical data , Pregnancy Tests/instrumentation , Pregnancy Tests/statistics & numerical data , Pregnancy , Reagent Kits, Diagnostic/statistics & numerical data , Time-to-Pregnancy , Adolescent , Adult , Diagnostic Self Evaluation , Equipment Design , Equipment Failure Analysis , Female , Humans , Middle Aged , Reference Values , Reproducibility of Results , Sensitivity and Specificity , United States/epidemiology , Young Adult
19.
Acad Emerg Med ; 20(8): 816-21, 2013 Aug.
Article in English | MEDLINE | ID: mdl-24033625

ABSTRACT

OBJECTIVES: The objective was to estimate the frequency of pregnancy testing among adolescent emergency department (ED) patients and to determine factors associated with testing. METHODS: This was a retrospective cross-sectional study using the National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2005 through 2009 of ED visits by females ages 14 to 21 years. The frequency of pregnancy testing among all visits was estimated for potential reproductive health complaints and for those associated with exposure to potentially teratogenic radiation. Multivariable logistic regression modeling was performed to calculate adjusted probabilities and odds ratios (ORs) with 95% confidence intervals (CIs) to evaluate factors associated with pregnancy testing by patient characteristics. RESULTS: The authors identified 11,531 visits, representing an estimated 41.0 million female adolescent ED visits. Of these, 20.9% (95% CI = 19.3% to 22.5%) included pregnancy testing. Among visits for potential reproductive health complaints and those associated with exposure to potentially teratogenic radiation, 44.5% (95% CI = 41.3% to 47.8%) and 36.7% (95% CI = 32.5% to 40.9%), respectively, included pregnancy testing. Among the entire study population, we found statistically significant differences in pregnancy testing by age, race or ethnicity, hospital admission, and geographic region (p < 0.001 for all). CONCLUSIONS: A minority of female adolescent ED visits included pregnancy testing, even if patients presented with potential reproductive health complaints or received exposure to ionizing radiation. Small but statistically significant differences in pregnancy testing rates were noted based on age, race or ethnicity, ED disposition, and geographic region. Future studies should focus on designing quality improvement interventions to increase pregnancy testing in adolescent ED patients, especially among those in whom pregnancy complications or the risk of potentially teratogenic radiation exposure is higher.


Subject(s)
Emergency Service, Hospital/statistics & numerical data , Pregnancy Tests/statistics & numerical data , Adolescent , Cross-Sectional Studies , Emergency Treatment , Female , Humans , Logistic Models , Pregnancy , Retrospective Studies , United States , Young Adult
20.
Arq Bras Cardiol ; 101(5): 418-22, 2013 Nov.
Article in English, Portuguese | MEDLINE | ID: mdl-24061686

ABSTRACT

BACKGROUND: The International Commission of Radiology recommends a pregnancy screening test to all female patients of childbearing age who will undergo a radiological study. Radiation is known to be teratogenic and its effect is cumulative. The teratogenic potential starts at doses close to those used during these procedures. The prevalence of positive pregnancy tests in patients undergoing electrophysiological studies and/or catheter ablation in our midst is unknown. OBJECTIVE: To evaluate the prevalence of positive pregnancy tests in female patients referred for electrophysiological study and/or radiofrequency ablation. METHODS: Cross-sectional study analyzing 2966 patients undergoing electrophysiological study and/or catheter ablation, from June 1997 to February 2013, in the Institute of Cardiology of Rio Grande do Sul. A total of 1490 procedures were performed in women, of whom 769 were of childbearing age. All patients were screened with a pregnancy test on the day before the procedure. RESULTS: Three patients tested positive, and were therefore unable to undergo the procedure. The prevalence observed was 3.9 cases per 1000 women of childbearing age. CONCLUSION: Because of their safety and low cost, pregnancy screening tests are indicated for all women of childbearing age undergoing radiological studies, since the degree of ionizing radiation needed for these procedures is very close to the threshold for teratogenicity, especially in the first trimester, when the signs of pregnancy are not evident.


Subject(s)
Abnormalities, Radiation-Induced/prevention & control , Catheter Ablation/adverse effects , Fetal Development/radiation effects , Pregnancy Tests/statistics & numerical data , Adult , Age Factors , Cross-Sectional Studies , Female , Humans , Pregnancy , Pregnancy Trimester, First , Prevalence , Risk Assessment , Young Adult
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