RESUMEN
Intrauterine devices (IUDs) are a commonly used form of long-acting reversible contraception, which either contain copper or levonorgestrel to prevent pregnancy. Although symptomatic patients with indwelling IUDs may first undergo ultrasound to assess for device malposition and complications, IUDs are commonly encountered on CT in patients undergoing evaluation for unrelated indications. Frequently, IUD malposition and complications may be asymptomatic or clinically unsuspected. For these reasons, it is important for the radiologist to carefully scrutinize the IUD on any study in which it is encountered. To do so, the radiologist must recognize that normally positioned IUDs are located centrally within the uterine cavity. IUDs are extremely effective in preventing pregnancy, though inadvertent pregnancy risk is higher with malpositioned IUDs. Presence of fibroids or Mullerian abnormalities may preclude proper IUD placement. Radiologists play an important role in identifying complications when they arise and special considerations when planning for an IUD placement. There is a wide range of IUD malposition, affecting IUDs differently depending on the type of IUD and its mechanism of action. IUD malposition is the most common complication, but embedment and/or partial perforation can and can lead to difficulty when removed. Retained IUD fragments can result in continued contraceptive effect. Perforated IUDs do not typically cause intraperitoneal imaging findings.
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Dispositivos Intrauterinos , Leiomioma , Embarazo , Femenino , Humanos , Dispositivos Intrauterinos/efectos adversos , Útero , Ultrasonografía , Tomografía Computarizada por Rayos XRESUMEN
Background: Endometrial stromal sarcoma (ESS) is extremely rare in pregnancy. It shares clinical and imaging features with more common pregnancy findings such as leiomyoma and molar gestations, which makes diagnosis challenging. Case: A 36-year-old patient presented at 8 weeks and 1 day gestation for vaginal bleeding. An intrauterine pregnancy with an appropriately sized embryo with heart motion and a 9.5 cm complex uterine mass was found on ultrasound. MRI showed an 11.4 cm cystic mass with nodular septations causing mass effect on the endometrial cavity. After extensive counseling, the patient underwent a gravid abdominal hysterectomy and bilateral salpingectomy. Final pathology showed low grade ESS. Conclusion: This case highlights the importance of evaluating suspicious uterine masses in pregnancy and the necessity for safe abortion access.
RESUMEN
We performed a retrospective cohort study of all Type 1 cesarean scar pregnancies (n=18) or cervical pregnancies (n=5) at an academic tertiary center after treatment with a cervical double balloon catheter from 2018 to 2022 to evaluate outcomes and maternal morbidity. Cervical double balloon catheter treatment was associated with no cases (95% confidence interval 0-16%) of maternal hemorrhage treated with transfusion, hysterectomy, or ICU admission. Treatment was successfully performed by nine different obstetrics and gynecology specialists.
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Cicatriz , Embarazo Ectópico , Embarazo , Femenino , Humanos , Cicatriz/etiología , Cicatriz/terapia , Estudios Retrospectivos , Cesárea/efectos adversos , Embarazo Ectópico/etiología , Embarazo Ectópico/terapia , CatéteresRESUMEN
OBJECTIVE: To measure the difference in procedure time between manual vacuum aspiration (MVA) and electric vacuum aspiration (EVA) during abortion procedures between 10 0/7 and 13 6/7 weeks gestation. STUDY DESIGN: We conducted a 1:1 randomized trial of individuals undergoing an abortion procedure between 10 0/7 and 13 6/7 weeks to MVA or EVA. Procedure time was the primary outcome. We performed an intention-to-treat analysis. A total of 132 patients (66 per arm) were needed to identify a 2-minute difference in time with 90% power and an alpha of 0.05. Given the non-parametric distribution of procedure times, we used Mann-Whitney U test to assess for differences in median procedure times. RESULTS: We randomized 146 participants; 74 to MVA and 72 to EVA. Median procedure times were similar between the 2 groups; EVA 2.4 minutes (range 0.9-6.9 min) and MVA 2.6 minutes (range 1.1-9.0 min, p = 0.12). When stratified by gestational age, EVA between 12 0/7 and 13 6/7 weeks had a shorter median procedure time compared to MVA (2.5 min, range 1.4-6.9 min vs. 3.5 min range 1.7-9.0), respectively (p = 0.005). One conversion occurred from MVA to EVA at 13 weeks. CONCLUSION: We found no difference in procedure time between MVA and EVA between 10 0/7 and 13 6/7 weeks gestation. MVA does take 1 minute longer than EVA when performed between 12 0/7-13 6/7 weeks; however, this difference is not likely be clinically significant. IMPLICATIONS: Procedure times are similar for manual and electric vacuum aspiration for uterine evacuation between 10 and 14 weeks and the rate of conversion is low.
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Aborto Inducido , Aborto Espontáneo , Aborto Inducido/métodos , Femenino , Edad Gestacional , Humanos , Embarazo , Primer Trimestre del Embarazo , Legrado por AspiraciónRESUMEN
Cost can be a barrier to accessing safe and affordable contraception. Therefore, we sought to understand how the availability and utilization of a low-cost levonorgestrel intrauterine system (hormonal IUD) impacts uptake relative to other contraceptive methods. Another objective was to determine if the percentage of self-pay women who obtained a hormonal IUD changed over time. Electronic health record (EHR) data was collected from five public health organizations enrolled in the 340B drug-pricing program (30 individual health centers) from April 15, 2014, through December 31, 2017, with most sites receiving Title X funding. The study captured data before and after low-cost hormonal IUD introduction. Interview data from 28 key informants provided a deeper understanding of how trends in hormonal IUD use changed after low-cost hormonal IUD introduction. Encounters from 101,075 women were analyzed. Locally weighted scatterplot smoothing (LOWESS) trends revealed an increasing utilization for all long-acting reversible contraception (LARC) and a decreasing trend for short-acting methods. Among self-pay women, hormonal IUD uptake increased 3 percentage points (p < .001) after the introduction of low-cost hormonal IUD. Privately insured women saw a 7-percentage point increase in hormonal IUD uptake while women whose family income was greater than 200% of the federal poverty level (FPL) saw a 13.9 percentage point increase in hormonal IUD uptake. The introduction of a low-cost hormonal IUD was associated with more self-pay and low-income women accessing this method. Access to and utilization of low-cost hormonal IUDs are complicated by many factors including product availability and provider training.
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Levonorgestrel , Anticoncepción Reversible de Larga Duración , Anticoncepción , Anticonceptivos , Femenino , Humanos , Estudios RetrospectivosRESUMEN
Clinical trials of contraceptives have often differed in their study designs, making cross-trial comparisons difficult. This brief report outlines some of the technical design features that can vary from trial to trial. For example, the overall number of menstrual cycles in a study has substantial impact on the final efficacy determination; however, the rules related to qualifying cycles can differ based on the length of the study and the statistical analysis plan. In two commonly used methods of calculating efficacy, the Pearl Index and the time-to-event analysis, inclusion of fewer menstrual cycles results in higher calculated failure rates. Statistical analysis plans for contraceptive trials have sometimes excluded menstrual cycles because of an absence of documented vaginal intercourse and the concomitant use of another birth control method. Other design features that have varied between contraceptive trials relate to body mass index inclusion/exclusion criteria and the definition of "on-treatment" pregnancy. In addition, study designs of non-hormonal products can differ from those of hormonal products in their length and rules for qualifying cycles. The Draft Guidance for Hormonal Contraception, published in 2019 by the US Food and Drug Administration (FDA), will hopefully lead to more uniform trial design in the future, particularly for hormonal products. In the meantime, health care providers and patients should be aware of the nuances in trial design that make direct comparisons about relative efficacy challenging.
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Anticoncepción , Anticonceptivos , Índice de Masa Corporal , Ensayos Clínicos como Asunto , Femenino , Humanos , Ciclo Menstrual , Embarazo , Estados UnidosRESUMEN
OBJECTIVE: To explore the relationship between abortion restrictions and maternal mortality in the United States. STUDY DESIGN: This was a retrospective study examining maternal mortality in the United States from 1995 to 2017. We used the Global Health Data Exchange and the Centers for Disease Control and Prevention WONDER databases to extract maternal mortality data for all 50 states for each year from 1995 to 2017. We categorized states as restrictive, neutral, or protective of abortion access according to policy information published by the Guttmacher Institute. We assessed associations between abortion restrictions and maternal mortality ratios (maternal deaths per 100,000 live births). RESULTS: In 1995, the mean maternal mortality ratios were similar across all groups of states (Restrictive 12.6, 95% CI 11.4-13.6; Neutral 12.2, 95% CI 10.9-13.4; Protective 10.9, 95% CI 9.6-11.9). Maternal mortality ratios increased for each group of states over time and in 2017, the mean maternal mortality ratio was higher in restrictive states than in protective states (Restrictive 28.5, 95% CI 20.7-35.1; Neutral 22.9, 95% CI 16.1-28.6; Protective 15.7, 95% CI 10.7-19.9). Regressions accounting for policy, state and year showed a statistically significant increase in maternal mortality ratios in restrictive states relative to neutral states (1.06, 95% CI 1.01-1.11) and a non-significant decrease associated with protective states (0.89, 95% CI 0.78-1.01). CONCLUSIONS: States that restrict abortion have higher maternal mortality than states that either protect or are neutral towards abortion. Further investigation is needed to determine how abortion restrictions are associated with increased maternal mortality. IMPLICATIONS: The association between abortion restrictions and maternal mortality may reflect the overall legislative priorities of individual states as restrictive states are less likely to pass proactive legislation demonstrated to improve maternal outcomes.
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Aborto Inducido , Muerte Materna , Aborto Legal , Femenino , Salud Global , Humanos , Mortalidad Materna , Embarazo , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: Assess the relationship between parity and prior route of delivery to levonorgestrel 52 mg intrauterine system (IUS) expulsion during the first 72 months of use. STUDY DESIGN: We evaluated women enrolled in the ACCESS IUS multicenter, Phase 3, open-label clinical trial of the Liletta levonorgestrel 52 mg IUS. Investigators evaluated IUS presence at 3 and 6 months after placement and then every 6 months and during unscheduled visits. We included women with successful placement and at least one follow-up assessment. We evaluated expulsion rates based on obstetric history; for prior delivery method subanalyses, we excluded 12 participants with missing delivery data. We determined predictors of expulsion using multivariable regression analyses. RESULTS: Of 1714 women with IUS placement, 1710 had at least one follow-up assessment. The total population included 986 (57.7%) nulliparous women. Sixty-five (3.8%) women experienced expulsion within 72 months, 50 (76.9%) within the first 12 months. Expulsion rates among nulliparous women (22/986 [2.2%]) or parous women with any pregnancy ending with a Cesarean delivery (6/195 [3.1%]) differed from parous women who only experienced vaginal deliveries (37/517 [7.2%]) (p < 0.001). In multivariable regression, obesity (adjusted odds ratio [aOR] 2.2, 95% confidence interval [CI] 1.3-3.7), parity (aOR 2.2, 95% CI 1.2-4.1), and non-white race (aOR 1.8, 95% CI 1.1-3.2) predicted expulsion. Among parous women, obesity (aOR 2.2, 95% CI 1.2-4.2) increased the odds and having ever had a cesarean delivery (aOR 0.4, 95% CI 0.1-0.9) decreased the odds of expulsion. CONCLUSION: IUS expulsion occurs in less than 4% of users over the first 6 years of use and occurs mostly during the first year. Expulsion is more likely among obese and parous women. IMPLICATIONS: Levonorgestrel 52 mg intrauterine system expulsion occured more commonly in parous than nulliparous women; the increase in parous women is primarily in women who had vaginal deliveries only. The association between obesity, delivery route, and IUS expulsion needs further elucidation.
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Anticonceptivos Femeninos , Dispositivos Intrauterinos Medicados , Cesárea , Femenino , Humanos , Levonorgestrel , Paridad , EmbarazoRESUMEN
OBJECTIVE: Evaluate reproductive function in nulligravid and gravid women after levonorgestrel 52 mg intrauterine system (IUS) discontinuation based on time to pregnancy. STUDY DESIGN: We evaluated women participating in the ACCESS IUS multicenter, Phase 3, open-label clinical trial of the Liletta(®) levonorgestrel 52 mg IUS who discontinued the IUS within 60 months of use and desired pregnancy. Study staff contacted participants every three months after IUS discontinuation for up to 12 months to determine whether pregnancy occurred. We excluded women who opted to stop attempting to conceive before 12 months. We evaluated 12-month conception rates in participants 16-35 years at IUS placement, comparing dichotomous outcomes using Fisher's exact test. We performed a multivariable analysis to assess the association of baseline characteristics, age at discontinuation, duration of IUS use, and positive sexually transmitted infection testing during IUS use with conception. RESULTS: Among 165 women who attempted to conceive, 142 (86.1%) did so within 12 months with a median time to conception of 92 days. The 12-month conception rates did not differ between nulligravid (66/76 [86.8%]) and gravid (76/89 [85.4%]) women (p = 0.83) and nulliparous (78/90 [86.7%]) and parous (64/75 [85.3%]) women (p = 0.83). In multivariable analysis, only obesity (aOR 0.3 [95% CI 0.1-0.8]) was associated with ability to conceive. CONCLUSIONS: After levonorgestrel 52 mg IUS discontinuation, women have rapid return of fertility in the year post-removal. Fertility rates after IUS removal do not vary based on gravidity, parity, age at discontinuation, or duration of IUS use. IMPLICATIONS: This contemporary IUS study included a large population of nulligravid and nulliparous women. IUS use over many years does not effect spontaneous fertility after IUS discontinuation, regardless of gravidity or parity. Providers and patients should have no concern about the impact of IUS use on future fertility.
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Anticonceptivos Femeninos , Dispositivos Intrauterinos Medicados , Femenino , Fertilización , Humanos , Levonorgestrel , Paridad , EmbarazoRESUMEN
BACKGROUND: The levonorgestrel 52-mg intrauterine system has proven efficacy for heavy menstrual bleeding treatment in clinical trials, but few data exist to demonstrate how rapidly the effects occur and the effects in women with self-reported heavy bleeding, as seen commonly in clinical practice. OBJECTIVE: Evaluate changes in bleeding patterns in women with self-reported heavy menstrual bleeding before levonorgestrel 52-mg intrauterine system insertion. STUDY DESIGN: A total of 1714 women aged 16-45 years old received a levonorgestrel 52-mg intrauterine system in a multicenter trial evaluating contraceptive efficacy and safety for up to 10 years. At screening, participants described their baseline menstrual bleeding patterns for the previous 3 months. Participants completed daily diaries with subjective evaluation of bleeding information for the first 2 years. For this analysis, we included women with at least 1 complete 28-day cycle of intrauterine system use and excluded women using a hormonal or copper intrauterine contraception in the month prior to study enrollment. We evaluated changes in menstrual bleeding and discontinuation for bleeding complaints per 28-day cycle over 26 cycles (2 years) in women who self-reported their baseline pattern as heavy. We also compared rates of amenorrhea, defined as no bleeding or spotting, within the entire study population in women with subjective heavy menstrual bleeding at baseline compared with those who did not complain of heavy menstrual bleeding. RESULTS: Of the 1513 women in this analysis, 150 (9.9%) reported baseline heavy menstrual bleeding. The majority of women reported no longer experiencing heavy menstrual bleeding by the end of cycle 1 (112/150, 74.7%) with even greater rates by cycle 2 (124/148, 83.8%). At the end of cycles 6, 13, and 26, 129 of 140 (92.1%; 95% confidence interval, 87.7%-96.6%), 114 of 123 (92.7%; 95% confidence interval, 88.1%-97.3%), and 100 of 103 (97.1%; 95% confidence interval, 93.8%-100%) women reported no heavy menstrual bleeding, respectively. After cycles 13 and 26, 63 of 123 (51.2%; 95% confidence interval, 42.4%-60.1%) and 66 of 103 (64.1%; 95% confidence interval, 54.8%-73.3%), respectively, reported their bleeding as amenorrhea or spotting only. A lower proportion of women with baseline self-reported heavy menstrual bleeding reported amenorrhea as compared with women in the overall study cohort without heavy menstrual bleeding at the end of 6 cycles (319 [25.5%] vs 21 [15.0%], P=.005) and 13 cycles (382 [34.4%] vs 26 [21.1%], P=.003); differences were not significant after 19 cycles (367 [37.2%] vs 36 [31.0%], P=.022) and 26 cycles (383 [43.5%] vs 38 [36.9%], P=.21). Only 4 (2.7%) women with baseline heavy menstrual bleeding discontinued for bleeding complaints (2 for heavy menstrual bleeding and 2 for irregular bleeding), all within the first year. CONCLUSION: Most women who self-report heavy menstrual bleeding experience significant improvement quickly after levonorgestrel 52-mg intrauterine system insertion. Discontinuation for bleeding complaints among women with baseline heavy menstrual bleeding is very low.
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Amenorrea/epidemiología , Agentes Anticonceptivos Hormonales/administración & dosificación , Dispositivos Intrauterinos Medicados , Levonorgestrel/administración & dosificación , Menorragia/fisiopatología , Menstruación , Adolescente , Adulto , Femenino , Humanos , Persona de Mediana Edad , Adulto JovenRESUMEN
The clinical performance of the Cobas CT/NG assay on the Cobas 6800/8800 systems (Cobas) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae was established in a multisite, prospective collection study using male and female urogenital specimens; supportive data from archived specimens were also included. The results obtained with the Cobas assay were compared with the patient infected status derived from a combination of U.S. Food and Drug Administration-approved nucleic acid amplification tests to determine the sensitivity and specificity of detection from each sample type. The sensitivity of Cobas for the detection of C. trachomatis in female specimens was 95.6% (95% confidence interval [CI], 92.4% to 97.4%) for urine; 98.6% (95% CI, 95.2% to 99.6%) and 99.2% (95% CI, 95.4% to 99.9%) for clinician- and self-collected vaginal swab specimens, respectively; 93.3% (95% CI, 89.6% to 95.7%) for endocervical swabs; and 92.5% (95% CI, 88.7% to 95.1%) for cervical swab samples in PreservCyt. The specificity for the detection of C. trachomatis was ≥98.8% for all female sample types. Sensitivity and specificity estimates of Cobas for the detection of C. trachomatis in male urine samples were 100% (96.8% to 100.0%) and 99.7% (95% CI, 99.2% to 99.9%), respectively. The sensitivity of Cobas for the detection of N. gonorrhoeae in female specimens was 94.8% (95% CI, 89.6% to 97.4%) for urine; 100.0% (95% CI, 87.9% to 100.0%) and 100.0% (95% CI, 87.9% to 100.0%) for clinician- and self-collected vaginal swab specimens, respectively; 97.0% (95% CI, 91.5% to 99.0%) for endocervical swabs; and 96.6% (95% CI, 90.6% to 98.8%) for cervical samples in PreservCyt; the specificity for all female sample types was >99.0%. The sensitivity and specificity of Cobas for detecting N. gonorrhoeae in male urine were 100.0% (95% CI, 95.8% to 100.0%) and 99.5% (95% CI, 98.8% to 99.8%), respectively. Fully automated assays help fill the clinical need for a sensitive, high-throughput screening tool to aid public health efforts to control C. trachomatis and N. gonorrhoeae infections.
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Infecciones por Chlamydia/orina , Chlamydia trachomatis/aislamiento & purificación , Gonorrea/orina , Técnicas de Diagnóstico Molecular/normas , Neisseria gonorrhoeae/aislamiento & purificación , Técnicas de Amplificación de Ácido Nucleico/instrumentación , Adolescente , Adulto , Anciano , Infecciones Asintomáticas , Cuello del Útero/microbiología , Infecciones por Chlamydia/diagnóstico , Técnicas de Laboratorio Clínico , Femenino , Gonorrea/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Técnicas de Diagnóstico Molecular/métodos , Técnicas de Amplificación de Ácido Nucleico/métodos , Estudios Prospectivos , Juego de Reactivos para Diagnóstico , Sensibilidad y Especificidad , Manejo de Especímenes , Sistema Urogenital/microbiología , Frotis Vaginal , Adulto JovenRESUMEN
OBJECTIVES: We aim to describe our experiences and identify patients who may benefit from referral to a peripheral nerve surgeon for removal of contraceptive subdermal implants in which neurovascular injury may occur, and describe a treatment pathway for optimal care. STUDY DESIGN: We reviewed the charts of 22 patients who were referred to the Division of Family Planning for difficult removal of etonogestrel contraceptive implants between January 1, 2014, and April, 1 2016. Of these, five were referred to a peripheral nerve surgeon due to pain or location of the implant. We evaluated and described these cases and, from our findings, developed recommendations for care in a multidisciplinary team approach. RESULTS: Two patients reported pain, including one with four previous failed removal attempts. In the two patients with pain, the implants were adherent to a sensory nerve. In another, the implant was within the biceps muscle and difficult to locate. In all cases, ultrasound imaging, general anesthesia and a wide exposure allowed for safe removal and good outcomes. Our multidisciplinary care approach has elucidated important referral and technical considerations that improve patient care and safety. CONCLUSION: When necessary, multidisciplinary care with a Family Planning expert and possibly a peripheral nerve surgeon may be beneficial in safely removing etonogestrel contraceptive implants that would be difficult or risky to remove in an ambulatory setting.
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Brazo/cirugía , Anticonceptivos Femeninos/administración & dosificación , Desogestrel/administración & dosificación , Remoción de Dispositivos/métodos , Adulto , Anticonceptivos Femeninos/uso terapéutico , Desogestrel/uso terapéutico , Implantes de Medicamentos , Femenino , Humanos , Persona de Mediana Edad , Ultrasonografía , Adulto JovenRESUMEN
To be healthy, support their families, and be productive members of their communities, women must have access to comprehensive reproductive health services including treatment of miscarriage and ectopic pregnancy and access to abortion, sterilization, and other contraceptive methods. However, in the United States, hospitals and legislative bodies are erecting barriers and limiting access to these basic health care services. These barriers are caused by factors such as hospital mergers (specifically those that are religiously affiliated); federal, state, and local legislation; hospital policies; and business-related decisions are threatening reproductive health care. Such barriers, of which women are often not even aware, put women at real risk of harm. This commentary provides clinical examples of these harms and recommends ways that obstetrician-gynecologists can get involved to publicize the consequences of these barriers and, hopefully, prevent them from occurring or break them down to promote women's health.
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Ginecología , Obstetricia , Rol del Médico , Servicios de Salud Reproductiva , Femenino , Humanos , Embarazo , Estados UnidosRESUMEN
BACKGROUND: Misperceptions persist that intrauterine device placement is related to pelvic infections and Chlamydia and gonorrhea testing results are needed prior to placement. OBJECTIVE: We sought to evaluate the relationship of Chlamydia and gonorrhea screening to pelvic infection for up to 2 years following placement of the levonorgestrel 52-mg intrauterine system. STUDY DESIGN: A total of 1751 nulliparous and multiparous females 16 to 45 years old enrolled in a multicenter trial designed to evaluate the efficacy and safety of a new levonorgestrel intrauterine system for up to 7 years. Participants had Chlamydia screening at study entry and yearly if they were age ≤25 years. Women also had baseline gonorrhea screening if testing had not been performed since starting their current sexual relationship. Those who changed sexual partners during the trial had repeated Chlamydia and gonorrhea testing. Intrauterine system insertion could occur on the same day as screening. Participants did not receive prophylactic antibiotics for intrauterine system placement. Investigators performed pelvic examinations after 12 and 24 months and when clinically indicated during visits at 3, 6, and 18 months after placement and unscheduled visits. Pelvic infection included any clinical diagnosis of pelvic inflammatory disease or endometritis. RESULTS: Most participants (n = 1364, 79.6%) did not have sexually transmitted infection test results available prior to intrauterine system placement. In all, 29 (1.7%) participants had positive baseline testing for a sexually transmitted infection (Chlamydia, n = 25; gonorrhea, n = 3; both, n = 1); 6 of these participants had known results (all with Chlamydia infection) prior to intrauterine system placement and received treatment before enrollment. The 23 participants whose results were not known at the time of intrauterine system placement received treatment without intrauterine system removal and none developed pelvic infection. The incidence of positive Chlamydia testing was similar among those with and without known test results at the time of intrauterine system placement (1.9% vs 1.5%, respectively, P = .6). Nine (0.5%) participants had a diagnosis of pelvic infection over 2 years after placement, all of whom had negative Chlamydia screening on the day of or within 1 month after intrauterine system placement. Infections were diagnosed in 3 participants within 7 days, 1 at 39 days, and 5 at ≥6 months. Seven participants received outpatient antibiotic treatment and 2 (diagnoses between 6-12 months after placement) received inpatient treatment. Two (0.1%) participants had intrauterine system removal related to infection (at 6 days and at 7 months after placement), both of whom only required outpatient treatment. CONCLUSION: Conducting Chlamydia and gonorrhea testing on the same day as intrauterine system placement is associated with a low risk of pelvic infection (0.2%). Over the first 2 years of intrauterine system use, infections are infrequent and not temporally related to intrauterine system placement. Pelvic infection can be successfully treated in most women with outpatient antibiotics and typically does not require intrauterine system removal. Women without clinical evidence of active infection can have intrauterine system placement and sexually transmitted infection screening, if indicated, on the same day.
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Infecciones por Chlamydia/diagnóstico , Anticonceptivos Femeninos/administración & dosificación , Endometritis/epidemiología , Gonorrea/diagnóstico , Dispositivos Intrauterinos Medicados , Levonorgestrel/administración & dosificación , Infección Pélvica/epidemiología , Adolescente , Adulto , Infecciones por Chlamydia/tratamiento farmacológico , Infecciones por Chlamydia/epidemiología , Femenino , Gonorrea/tratamiento farmacológico , Gonorrea/epidemiología , Humanos , Persona de Mediana Edad , Enfermedad Inflamatoria Pélvica/epidemiología , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Enfermedades de Transmisión Sexual/diagnóstico , Enfermedades de Transmisión Sexual/tratamiento farmacológico , Enfermedades de Transmisión Sexual/epidemiología , Factores de Tiempo , Adulto JovenRESUMEN
OBJECTIVE: To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. STUDY DESIGN: Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. RESULTS: A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. CONCLUSION: The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. IMPLICATIONS STATEMENT: A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.
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Anticoncepción/métodos , Anticonceptivos Femeninos/administración & dosificación , Dispositivos Intrauterinos Medicados/efectos adversos , Levonorgestrel/administración & dosificación , Adolescente , Adulto , Femenino , Humanos , Expulsión de Dispositivo Intrauterino , Persona de Mediana Edad , Paridad , Infección Pélvica/epidemiología , Infección Pélvica/etiología , Embarazo , Índice de Embarazo , Factores de Tiempo , Hemorragia Uterina/epidemiología , Hemorragia Uterina/etiología , Adulto JovenRESUMEN
OBJECTIVE: To investigate whether age 14 to 19 years and nulliparity are associated with expulsion of levonorgestrel and copper intrauterine devices (IUDs). METHODS: This was a planned secondary analysis of the Contraceptive CHOICE Project. We used Kaplan-Meier survival analysis to estimate expulsion rates for the first levonorgestrel or copper IUD received during study participation. Cox proportional hazards regression models were used to investigate baseline characteristics associated with expulsion. RESULTS: A total of 5,403 females were included; 4,219 (78%) used the levonorgestrel IUD and 1,184 (22%) used the copper IUD. There were 432 initial expulsions reported. The 36-month cumulative expulsion rate was 10.2 per 100 IUD users and did not vary by IUD type (levonorgestrel IUD 10.1 compared with copper IUD 10.7, P=.99). In the bivariate analysis, multiple characteristics including age, nulliparity, immediate postabortion insertion, and heavy menses were associated with expulsion. The cumulative rate of expulsion was lower in nulliparous women compared with parous women (8.4 compared with 11.4; P<.001) and higher in females aged 14 to 19 compared with older women (18.8 compared with 9.3; P<.001). After adjusting for confounders and stratifying by IUD type, the hazard ratio of expulsion for females aged 14 to 19 years was 2.26 (95% confidence interval [CI] 1.68-3.06) for the levonorgestrel IUD and 3.06 (95% CI 1.75-5.33) for the copper IUD. Compared to parous levonorgestrel IUD users, expulsion was lower for nulliparous levonorgestrel IUD users (adjusted hazard ratio 0.59, 95% CI 0.44-0.78). CONCLUSION: IUD expulsions were not increased in nulliparous females. More expulsions were observed in females aged 14 to 19 compared with older women regardless of parity or IUD type. LEVEL OF EVIDENCE: : II.
Asunto(s)
Expulsión de Dispositivo Intrauterino/efectos adversos , Dispositivos Intrauterinos Medicados/efectos adversos , Levonorgestrel/farmacología , Paridad , Índice de Embarazo/tendencias , Adolescente , Adulto , Factores de Edad , Análisis de Varianza , Distribución de Chi-Cuadrado , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Dispositivos Intrauterinos de Cobre/efectos adversos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Análisis Multivariante , Embarazo , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Medición de Riesgo , Factores de Tiempo , Adulto JovenRESUMEN
OBJECTIVE: The objective of the study was to evaluate the prevalence of medical contraindications in a large group of women seeking combined hormonal contraception (CHC). STUDY DESIGN: The Contraceptive CHOICE Project is a prospective cohort study designed to promote the use of long-acting reversible contraceptive methods to reduce unintended pregnancies in the St Louis region. During baseline enrollment, participants were asked about their desired methods of contraception and medical history. Potential medical contraindications were defined as self-reported history of hypertension, myocardial infarction, cerebral vascular accidents, migraines with aura, any migraine and age 35 years or older, smoking in women older than 35 years, venous thromboembolism, or liver disease. We reviewed all research charts of women with self-reported medical contraindications to verify all conditions. Binomial 95% confidence intervals (CIs) were calculated around percentages. RESULTS: Between August 2007 and December 2009, 5087 women who enrolled in the CHOICE Project provided information about their medical history and 1010 women (19.9%) desired CHC at baseline. Seventy women (6.93%; 95% CI, 5.44-8.68%) were defined as having a potential medical contraindication to CHC at baseline. After chart review, only 24 of 1010 participants desiring CHC (2.38%; 95% CI, 1.53-3.52%) were found to have true medical contraindications to CHC including 17 with hypertension, 2 with migraines with aura, 2 with a history of venous thromboembolism, and 3 smokers aged 35 years or older. CONCLUSION: The prevalence of medical contraindications to CHC was very low in this large sample of reproductive-aged women. This low prevalence supports provision of CHC without a prescription.
Asunto(s)
Anticonceptivos Orales Combinados , Anticonceptivos Hormonales Orales , Adulto , Factores de Edad , Estudios de Cohortes , Contraindicaciones , Femenino , Humanos , Estudios Prospectivos , Factores de Riesgo , FumarRESUMEN
OBJECTIVE: To estimate whether women who receive an immediate postabortion etonogestrel subdermal implant have higher discontinuation rates than women who undergo an interval insertion (insertion not associated with a recent pregnancy). METHODS: This was a secondary analysis of the Contraceptive CHOICE Project. We compared 12-month continuation rates for the subdermal implant between women undergoing immediate postabortion placement and women who underwent an interval placement. Continuation rates were compared using Kaplan-Meier estimator of survival function and Cox proportional hazard models. RESULTS: Over the study period, 141 women received the implant immediately postabortion and 935 women underwent an interval placement. The 12-month continuation rates were similar: 81.5% among women undergoing immediate postabortion placement and 82.8% among women undergoing interval placement (P=.54). In the survival analysis, women who received an immediate postabortion implant were no more likely to discontinue their method than women who had an interval placement (adjusted hazard ratio 1.04, 95% confidence interval 0.68-1.60). The most common reason given for discontinuation was frequent or irregular bleeding, which was reported by 65.4% of women discontinuing in the immediate postabortion group and 56.7% in the interval group. CONCLUSION: Women who undergo immediate postabortion placement of the subdermal implant have high rates of continuation that are equivalent to women undergoing interval insertion. Immediate postabortion long-acting reversible contraceptives should be available to women undergoing induced abortion to decrease the risk of repeat unplanned pregnancy. LEVEL OF EVIDENCE: II.
Asunto(s)
Anticonceptivos Femeninos/uso terapéutico , Desogestrel/administración & dosificación , Implantes de Medicamentos/administración & dosificación , Privación de Tratamiento , Adolescente , Adulto , Cuidados Posteriores , Estudios de Cohortes , Anticonceptivos Femeninos/administración & dosificación , Anticonceptivos Femeninos/efectos adversos , Desogestrel/efectos adversos , Femenino , Humanos , Persona de Mediana Edad , Embarazo , Estudios Prospectivos , Factores de Tiempo , Hemorragia Uterina/inducido químicamente , Adulto JovenRESUMEN
OBJECTIVE: To analyze a nationally representative sample of women for correlates of dual-contraceptive-method use. MATERIALS AND METHODS: We conducted an analysis of the National Survey of Family Growth, 2006-2008, a cross-sectional survey of reproductive-aged women in the United States. RESULTS: Dual method use was reported by 7.3% of the 5,178 women in the sample. Correlates of higher rates of dual-contraceptive-method use included age younger than 36 years and nonmarried marital status. Lower rates of dual method use were observed for women with less than a high-school education and women without consistent health insurance in the past year. Compared to women using oral contraceptives, use of the contraceptive injection or long-acting reversible contraception was associated with lower dual-method use. CONCLUSIONS: The overall rate of dual-method use in the USA is low. Future interventions to promote dual method use should target high-risk groups with modifiable risk factors.
Asunto(s)
Conducta Anticonceptiva , Anticoncepción/métodos , Enfermedades de Transmisión Sexual/prevención & control , Adolescente , Adulto , Factores de Edad , Condones/estadística & datos numéricos , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Estados Unidos , Adulto JovenRESUMEN
OBJECTIVE: The purpose of this study was to determine women's knowledge of contraceptive effectiveness. STUDY DESIGN: We performed a cross-sectional analysis of a contraceptive knowledge questionnaire that had been completed by 4144 women who were enrolled in the Contraceptive CHOICE Project before they received comprehensive contraceptive counseling and chose their method. For each contraceptive method, women were asked "what percentage would get pregnant in a year: <1%, 1-5%, 6-10%, >10%, don't know." RESULTS: Overall, 86% of subjects knew that the annual risk of pregnancy is >10% if no contraception is used. More than 45% of women overestimate the effectiveness of depo-medroxyprogesterone acetate, pills, the patch, the ring, and condoms. After adjustment for age, education, and contraceptive history, the data showed that women who chose the intrauterine device (adjusted relative risk, 6.9; 95% confidence interval, 5.6-8.5) or implant (adjusted relative risk, 5.9; 95% confidence interval, 4.7-7.3) were significantly more likely to identify the effectiveness of their method accurately compared with women who chose either the pill, patch, or ring. CONCLUSION: This cohort demonstrated significant knowledge gaps regarding contraceptive effectiveness and over-estimated the effectiveness of pills, the patch, the ring, depo-medroxyprogesterone acetate, and condoms.