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1.
Contraception ; 2020 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-32387328

RESUMO

OBJECTIVES: To evaluate whether etonogestrel concentrations are reduced to a level that could potentially reduce contraceptive efficacy when the etonogestrel contraceptive implant is used concomitantly with dolutegravir-based antiretroviral therapy (ART). STUDY DESIGN: We conducted a non-randomized, open-label, cross-sectional pharmacokinetic study among women using single-rod etonogestrel contraceptive implants in Botswana. We compared plasma etonogestrel concentrations, sampled at a single time-point between 3 and 12 months from implant insertion, among implant users living with HIV and receiving dolutegravir-based ART with HIV-negative implant users. We also assessed concentrations among implant users living with HIV and receiving efavirenz-based ART. We compared geometric mean etonogestrel concentrations analyzing data from 142 participants: 97 HIV-negative, 30 using dolutegravir, and 15 using efavirenz. RESULTS: The groups were similar. Duration of implant use was between 3 and 12 months (median=5). Geometric mean etonogestrel plasma concentrations and 90% confidence intervals of the mean were 227.5(212.4-243.8), 289.6(251.8-333.0) and 76.4(63.9-91.4) pg/mL among the HIV-negative, dolutegravir- and efavirenz-based ART groups, respectively. All women in the HIV-negative and dolutegravir-based ART groups had etonogestrel concentrations above 90pg/mL; 9/15 women (60%) using efavirenz-based ART had concentrations below 90 pg/mL. On average, etonogestrel levels were lower among individuals who had implants inserted for longer durations. CONCLUSIONS: Implant users receiving dolutegravir-based ART had a higher mean etonogestrel concentration compared to HIV-negative women, and none had etonogestrel concentrations below the posited threshold for ovulation suppression. In contrast, women in the efavirenz-group had much lower etonogestrel concentrations. Overall, these data provide evidence that the etonogestrel implant may be effectively combined with dolutegravir-based ART regimens. IMPLICATIONS: The etonogestrel implant remains a highly effective contraceptive option for women living with HIV who use dolutegravir-based ART.

2.
Contraception ; 2020 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-32416145

RESUMO

OBJECTIVE: To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism. Study Design We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information. RESULTS: Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n=11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days. CONCLUSIONS: Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use. Implications A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.

3.
Contraception ; 101(2): 67-68, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32061321
4.
Am J Obstet Gynecol ; 222(4S): S883.e1-S883.e6, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31945336

RESUMO

BACKGROUND: Prescribing information for the levonorgestrel-releasing intrauterine system allows placement when the clinician is reasonably certain the patient is not pregnant. A 6 item checklist aids clinicians in determining pregnancy risk but may be too restrictive, resulting in delaying placement for many women. Same-day placement, however, may risk placement during an unrecognized luteal-phase pregnancy, that is, a preimplantation fertilized ovum not yet detectable by urine pregnancy test. OBJECTIVE: We assessed the applicability of pregnancy checklist criteria in 2 gynecology practices that routinely provide same-day placements following a negative urine pregnancy test. STUDY DESIGN: In this retrospective cohort study, we reviewed electronic medical records of all women who underwent levonorgestrel-releasing intrauterine system placement from July 2009 to August 2012. We evaluated each record to identify whether the woman met any of the checklist criteria to exclude pregnancy. We ascertained luteal-phase pregnancies and other outcomes within 12 months following placement. RESULTS: Of 885 placements, 293 (33%) were immediately after abortion. Of the remaining 592 placements, 353 (60%) met at least 1 pregnancy checklist criterion to rule out pregnancy but 239 (40%) met none. Two percent received levonorgestrel emergency contraception at the time of placement. One luteal-phase pregnancy occurred in the group not meeting pregnancy checklist criteria. Removals and expulsions were rare and similar whether or not patients met checklist criteria. CONCLUSION: In 2 practices that provide same-day intrauterine system placements, strict adherence to pregnancy checklist criteria would have resulted in 239 patients (40%) not receiving a same-day intrauterine system. Twelve month outcomes were similar whether or not patients met pregnancy checklist criteria. Providers need not withhold intrauterine system placement based on the pregnancy checklist criteria.

5.
Obstet Gynecol ; 135(2): 319-327, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31923062

RESUMO

OBJECTIVE: To evaluate the relative risk of cervical neoplasms among copper intrauterine device (Cu IUD) and levonorgestrel-releasing intrauterine system (LNG-IUS) users. METHODS: We performed a retrospective cohort analysis of 10,674 patients who received IUDs at Columbia University Medical Center. Our data were transformed to a common data model and are part of the Observational Health Data Sciences and Informatics network. The cohort patients and outcomes were identified by a combination of procedure codes, condition codes, and medication exposures in billing and claims data. We adjusted for confounding with propensity score stratification and propensity score 1:1 matching. RESULTS: Before propensity score adjustment, the Cu IUD cohort included 8,274 patients and the LNG-IUS cohort included 2,400 patients. The median age for both cohorts was 29 years at IUD placement. More than 95% of the LNG-IUS cohort used a device with 52 mg LNG. Before propensity score adjustment, we identified 114 cervical neoplasm outcomes. Seventy-seven (0.9%) cervical neoplasms were in the Cu IUD cohort and 37 (1.5%) were in the LNG-IUS cohort. The propensity score matching analysis identified 7,114 Cu IUD and 2,174 LNG-IUS users, with covariate balance achieved over 16,827 covariates. The diagnosis of high-grade cervical neoplasia was 0.7% in the Cu IUD cohort and 1.8% in the LNG-IUS cohort (2.4 [95% CI 1.5-4.0] cases/1,000 person-years and 5.2 [95% CI 3.7-7.1] cases/1,000 person-years, respectively). The relative risk of high-grade cervical neoplasms among Cu IUD users was 0.38 (95% CI 0.16-0.78, P<.02) compared with LNG-IUS users. By inspection, the Kaplan-Meier curves for each cohort diverged over time. CONCLUSION: Copper IUD users have a lower risk of high-grade cervical neoplasms compared with LNG-IUS users. The relative risk of cervical neoplasms of LNG-IUS users compared with the general population is unknown.

6.
Contraception ; 101(3): 159-161, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31786203

RESUMO

OBJECTIVE: To assess 6-year contraceptive efficacy and safety of a levonorgestrel 52 mg intrauterine system (IUS). STUDY DESIGN: We assessed pregnancy rates through 72 months in women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n = 1751) in an ongoing 10-year phase-3 trial. RESULTS: Over six years, nine pregnancies occurred (none in year 6) for a life-table pregnancy rate of 0.87 (95% CI 0.44-1.70). Adverse event rates remain low through 6 or more years of use. Two expulsions occurred in year 6. CONCLUSION: This levonorgestrel 52 mg IUS is a highly effective and safe contraceptive over 6 years of use. IMPLICATIONS: The levonorgestrel 52 mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.

7.
Contraception ; 101(1): 1-2, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31847954
8.
J Adolesc Health ; 65(5): 660-666, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31495641

RESUMO

PURPOSE: Personalized and interactive text messaging interventions may increase participant engagement; yet, how to design messages that retain adolescent attention and positively affect sexual health behaviors remains unclear. The purpose of this study was to identify the characteristics of sexual health text messages perceived as engaging by sexually active adolescent females. METHODS: We conducted semistructured, open-ended interviews with sexually active females aged 14-19 in one urban emergency department. Participants received automated sexual health information sent via an interactive, two-way texting format. The 343 messages viewed by participants were based on key stakeholder input, relevant theoretical models, and existing evidence-based guidelines. Interviews elicited feedback. Enrollment continued until saturation of themes. Interviews were recorded, transcribed, and coded based on thematic analysis using NVivo 10. RESULTS: Participants (n = 31) were predominantly Hispanic (28; 90%), insured (29; 94%), and recently sexually active (24; 77%). Themes were as follows: (1) Tone: messages should be direct, factual, entertaining, and respect adolescent autonomy; messages should not be intrusive, presumptive, or preachy. (2) Emotion evoked: participants preferred messages that provoked thought, validated feelings, and empowered. Messages from a reliable source felt comforting, making participants feel cared for and special. (3) Interactivity: participants favored messages that offered choices, such as a mini-conversation. (4) Personalization: messages should look similar to adolescent digital preferences but be individually tailored with relatable characters. CONCLUSIONS: This study informs the tone, structure, and style of sexual health text messages directed toward adolescent females in the emergency department. Future work should consider these characteristics when designing digital interventions to engage adolescent females.

9.
Contraception ; 100(6): 438-444, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31398307

RESUMO

OBJECTIVES: To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S). STUDY DESIGN: We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS conducted in 17 US and 7 international sites. Participants (age 18-40 years; BMI ≤29 kg/m2) followed a 21/7-day in/out schedule of CVS use for up to 13 cycles and recorded vaginal bleeding daily in paper diaries. Scheduled and unscheduled B/S were summarized by cycle. We used multiple logistic regression to identify factors associated with unscheduled bleeding/spotting, based on the first 4 cycles only. RESULTS: Analysis included data from 2070 participants (16,408 cycles). Ninety-eight percent documented scheduled B/S [mean (SD): 4.9 (1.1) days/cycle)]. Absence of scheduled B/S was 5-8% of women/cycle. Unscheduled B/S ranged from 13.2% to 21.7% of women per cycle. Few women (1.8%) discontinued prematurely due to unacceptable bleeding. Black women were more likely to report unscheduled B/S than White women [Adjusted odds ratio (AOR) = 1.49, 95% confidence interval (CI) = 1.14-1.94]. Women with fewer years of schooling [

10.
Lancet Glob Health ; 7(8): e1054-e1064, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31231065

RESUMO

BACKGROUND: A ring-shaped, contraceptive vaginal system designed to last 1 year (13 cycles) delivers an average of 0·15 mg segesterone acetate and 0·013 mg ethinylestradiol per day. We evaluated the efficacy of this contraceptive vaginal system and return to menses or pregnancy after use. METHODS: In two identically designed, multicentre, open-label, single-arm, phase 3 trials (one at 15 US academic and community sites and one at 12 US and international academic and community sites), participants followed a 21-days-in, 7-days-out segesterone acetate and ethinylestradiol contraceptive vaginal system schedule for up to 13 cycles. Participants were healthy, sexually active, non-pregnant, non-sterilised women aged 18-40 years. Women were cautioned that any removals during the 21 days of cyclic use should not exceed 2 h, and used daily paper diaries to record vaginal system use. Consistent with regulatory requirements for contraceptives, we calculated the Pearl Index for women aged 35 years and younger, excluding adjunctive contraception cycles, as the primary efficacy outcome measure. We also did intention-to-treat Kaplan-Meier life table analyses and followed up women who did not use hormonal contraceptives or desired pregnancy after study completion for 6 months for return to menses or pregnancy. The trials are registered with ClinicalTrials.gov, numbers NCT00455156 and NCT00263341. FINDINGS: Between Dec 19, 2006, and Oct 9, 2009, at the 15 US sites, and between Nov 1, 2006, and July 2, 2009, at the 12 US and international sites we enrolled 2278 women. Our overall efficacy analysis included 2265 participants (1130 in the US study and 1135 in the international study) and 1303 (57·5%) participants completed up to 13 cycles. The Pearl Index for the primary efficacy group was 2·98 (95% CI 2·13-4·06) per 100 woman-years, and was well within the range indicative of efficacy for a contraceptive under a woman's control. The Kaplan-Meier analysis revealed the contraceptive vaginal system was 97·5% effective, which provided further evidence of efficacy. Pregnancy occurrence was similar across cycles. All 290 follow-up participants reported return to menses or became pregnant (24 [63%] of 38 women who desired pregnancy) within 6 months. INTERPRETATION: The segesterone acetate and ethinylestradiol contraceptive vaginal system is an effective contraceptive for 13 consecutive cycles of use. This new product adds to the contraceptive method mix and the 1-year duration of use means that women do not need to return to the clinic or pharmacy for refills every few months. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health, the US Agency for International Development, and the WHO Reproductive Health Research Department.

11.
Contraception ; 100(4): 269-274, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31226320

RESUMO

OBJECTIVE(S): To describe differences in contraceptive knowledge, attitudes and use among HIV-infected and HIV-uninfected women served by an academic medical center in New York City and to describe gaps in knowledge and practice of gynecologic and HIV clinicians providing care at the same clinic sites where patients completed surveys. STUDY DESIGN: We conducted a survey comparing contraceptive knowledge, attitudes, reproductive histories and long-acting reversible contraception (LARC) use in HIV-infected and -uninfected women. We also conducted a survey to elicit clinician demographic characteristics and education, contraceptive practice patterns and their knowledge of current contraceptive guidelines. We surveyed clinicians and patients at five ambulatory sites. RESULTS: We screened 90% of patients approached. All 257 women who were eligible completed a survey. These included 107 (42%) HIV-infected women and 150 (58%) HIV-uninfected women. HIV-infected women were older, were more likely to be black/African-American, were less likely to be Latina, were more likely to receive public assistance and had lower educational attainment. HIV-infected women reported lower lifetime LARC use (12% vs. 28%) and higher recent condom use (58% vs. 25%) than HIV-uninfected women. Both groups reported similar attitudes toward intrauterine devices (IUDs) and implants. HIV clinicians were less likely to have had training in or discuss LARC methods with their patients. CONCLUSIONS: HIV-infected women were less likely to be current (last 30 days) or ever LARC users, despite having similar attitudes toward IUDs and implants, compared to HIV-uninfected women. HIV providers had lower levels of knowledge of HIV-specific contraceptive guidelines compared with gynecology practitioners. IMPLICATIONS: HIV-infected women and their providers share a knowledge gap regarding LARC. Increased interdisciplinary collaboration may help mitigate the resulting disparities in access to highly effective contraception in HIV-infected women. Knowledge of HIV-specific contraceptive guidelines and ability to place contraceptive implants were low among all surveyed providers, suggesting need for additional training.

13.
Contraception ; 99(6): 329-334, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30871934

RESUMO

OBJECTIVE: To evaluate changes in the bone turnover markers CTx and P1NP during 6 months' use of novel continuous contraceptive vaginal rings delivering Nestorone (NES) 200 mcg/day and three doses of estradiol (E2) (10, 20, and 40 mcg/day). STUDY DESIGN: This randomized trial enrolled 189 women who used two consecutive vaginal rings over 180 days. Frequent blood sampling permitted analysis of NES, E2, CTx and P1NP concentrations. The bone-turnover marker analyses included only women with complete sampling and excluded women with characteristics that might interfere with accurate measurement of bone markers such as afternoon sampling, poor ring compliance or recent pregnancy. We evaluated the change from baseline to 6 months in CTx and P1NP, stratified by ring dose and by average circulating E2 concentrations. RESULTS: One hundred fifty-one women completed the study, and 82 women had complete data available for the bone marker analyses; the three dosage groups were balanced with regard to baseline characteristics. E2 concentrations remained low throughout treatment, regardless of which dose ring the participant used. Individual CTx changes from baseline averaged 27±56% (p<.01). Similarly, individual P1NP changes averaged 11±33% (p=.04). These increases were within the premenopausal reference ranges, and unrelated to treatment dose or to circulating E2 concentrations. CONCLUSIONS: The low E2 dose of these rings was associated with low E2 concentrations and modest increases in serum bone turnover makers. Because we have only 6-month bone turnover markers and no direct evidence of bone loss or bone density change, these results must be interpreted with caution. IMPLICATIONS: Nestorone, a 19-norprogesterone derivative, leads to complete ovarian suppression, which should yield excellent contraceptive effectiveness. To prevent potential adverse effects on bone, the NES contraceptive ring should be combined with higher doses of E2 than were assessed in this study.

14.
Contraception ; 99(4): 256-263, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30684471

RESUMO

OBJECTIVE: The objective was to evaluate the pharmacokinetics (PKs) of levonorgestrel (LNG)-containing combined oral contraceptives (COCs) in obese women. STUDY DESIGN: We pooled and reanalyzed data from 89 women with different body mass index (BMI) categories from four clinical studies. The LNG and ethinyl estradiol (EE) PKs were analyzed utilizing a zero-order absorption (K0), two-compartment PK model to evaluate key PK parameters in relation to a range of weights, BMI and body surface area (BSA). RESULTS: Increasing of body habitus metrics is correlated with decreasing Cmax (p<.0001) and AUCτ (p<.05) for both LNG and EE, but no correlation was found for Cmin (p≥.17). Increasing weight and BMI were associated with a modest increase (p≤.056) of clearance (CL) and appreciable increases of central volume (V1, p<.05), distribution clearance (CLd, p≤.001) and peripheral volume (V2, p<.0001) for LNG. For EE, increases in CL (p≤.009) were found with greater weight, BMI and BSA. Values of V1, CLd and V2 also increased (p<.0001) in obese subjects. The half-life and steady-state volume were greater among obese women (p<.0001) for both LNG and EE. LNG and EE PK parameters correlated well (p≤.006 for all), indicating that individual subject physiology affected both drugs similarly. CONCLUSIONS: The primary effects of obesity on LNG and EE were a modest increase in CL and a marked increase in distribution parameters. We observed no obesity-related differences in trough LNG and EE concentrations. IMPLICATIONS: This population PK analysis demonstrated reduced systemic exposure to LNG/EE oral contraceptives in obese subjects (Cmax and AUCτ); these particular differences are unlikely to lower contraceptive effectiveness among obese women who are correctly using LNG-containing contraceptives.

15.
Patient Educ Couns ; 102(3): 536-541, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30385101

RESUMO

OBJECTIVES: Pregnancy options counseling, or nondirective counseling of patients with unintended pregnancy, is a "necessary competency" for medical students according the Association of Professors of Gynecology and Obstetrics. Narrative Medicine (NM) utilizes stories of illness to inform clinical practice and promotes self-reflection in medical education. The authors analyzed the effect of a NM workshop on medical students' ability to provide pregnancy options counseling. METHODS: The authors randomized students in the major clinical year at Columbia University Medical Center (CUMC) to either a 2-hour NM workshop or to a control intervention. The NM group participated in reading and reflective writing exercises addressing varying perspectives on pregnancy. Students then completed a video-taped and numerically-scored OSCE (Objective Structured Clinical Examination) regarding pregnancy options counseling. The authors compared mean OSCE scores between the groups. RESULTS: The study analyzed 103 participants. Overall mean OSCE scores were higher in the NM group (11.9 ± 1.5, n = 51) than the control group (11.3 ± 1.6, n = 52) (p = 0.049). CONCLUSIONS: Students undergoing a NM workshop had higher scores on a pregnancy options counseling OSCE. PRACTICE IMPLICATIONS: This brief intervention may aid future physicians in providing nondirective pregnancy options. This novel approach to teaching is an easily shared learning tool.


Assuntos
Aconselhamento/educação , Ginecologia/educação , Medicina Narrativa , Obstetrícia/educação , Estudantes de Medicina/psicologia , Incerteza , Adulto , Currículo , Educação Médica , Avaliação Educacional , Feminino , Humanos , Gravidez , Estudantes de Medicina/estatística & dados numéricos , Redação
16.
Contraception ; 99(3): 143-147, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30529393

RESUMO

OBJECTIVES: To assess pain-management using auricular acupuncture as an adjunct to ibuprofen and paracervical block during first trimester uterine aspiration, and to assess auricular acupuncture's effect on anxiety. STUDY DESIGN: This randomized, double-blinded, three-arm trial enrolled women undergoing uterine aspiration for spontaneous or induced abortion. Study participants were randomized 1:1:1 to receive auricular acupuncture, placebo, or usual care alone. Participants in all groups received ibuprofen and paracervical block (usual care). The main outcome was maximum pain reported at the end of the procedure measured using a Visual Analog Scale; we compared those receiving auricular acupuncture to those receiving usual care alone. We also compared auricular acupuncture to placebo and placebo to usual care alone. Finally, we compared the maximum anxiety scores between participants randomized to auricular acupuncture, placebo, and usual care alone. RESULTS: We randomized 153 women over 9 months, and analyzed 52 participants in the auricular acupuncture group, 49 in the placebo group, and 49 in the usual care group. The groups had similar baseline characteristics. After uterine aspiration, participants reported median maximum pain scores as follows: auricular acupuncture 39.5 (interquartile range (IQR) 11, 64.5), placebo 70.0 (IQR 40.5, 84), and usual care alone 71.0 (IQR 32, 91.5) (p<0.01). In pairwise comparisons, the median maximum pain score after auricular acupuncture was lower than placebo and usual-care groups (p<0.01 for both). Post-procedure median anxiety scores were 11.5, 31.0 and 44.0, respectively (p=.01). CONCLUSIONS: Women undergoing first trimester uterine aspiration assigned to auricular acupuncture reported substantially less pain and anxiety than women assigned to placebo or usual care. IMPLICATIONS: Auricular acupuncture may be a useful adjunct to ibuprofen and paracervical block during first trimester uterine aspiration. This approach to managing pain and anxiety could avoid the operational complexities and expenses of sedation and opioid use.

17.
Contraception ; 98(3): 171-173, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30193687

RESUMO

The recent Danish cohort study reported a 20% increased risk of breast cancer among current and recent hormonal contraception users. These results are largely consistent with previous studies. This study did not report on stage of disease at diagnosis, and it is not clear to what extent the apparent increased risk may be due to a small advance in the timing of diagnosis. This study did not report on the risk associated with the use of a 20-mcg ethinyl estradiol pill. They did find an increasing risk in current users of longer duration and an increased risk with use of the levonorgestrel intrauterine system-both of these potentially important findings have not been consistently found in previous studies and require further investigation. The breast cancer effects described now in multiple studies wane with time, and in the long term, hormonal contraception use has been found not to be associated with any increased total cancer risk.


Assuntos
Neoplasias da Mama , Estudos de Coortes , Anticoncepção , Etinilestradiol , Humanos , Levanogestrel
20.
Contraception ; 98(3): 199-204, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29752922

RESUMO

OBJECTIVES: To compare transabdominal sonography (TAS) to transvaginal sonography (TVS) in medical abortion eligibility assessment, specifically to measure how often clinicians chose to order additional testing for eligibility assessment following TAS and TVS, and to look for differences by patient and clinician characteristics. Also, to compare patient acceptability between the two modalities. STUDY DESIGN: This pragmatic multisite randomized noninferiority trial compared TAS to TVS at 10 New York City and New Jersey health centers that provide medical abortion. Women seeking medical abortion were randomized 1:1 to receive TAS or TVS. Following the study ultrasound examination, clinicians determined whether participants were eligible for medical abortion based on these results or warranted further testing. All participants completed an acceptability questionnaire. We compared additional testing and acceptability between TAS and TVS. RESULTS: Of those randomized to TAS, 63/317 (19.9%) received additional testing compared to 15/312 (4.8%) randomized to TVS. After TAS, most additional testing consisted of a same-day TVS. Other tests included ß-hCG testing, scheduled repeat sonography or return visit. After TAS, 13.4% seen by physicians and 27.6% seen by advanced practice nurses (APNs) received additional testing (p<.01). Additional testing was more common in early gestational ages for both groups. We enrolled too few women with a body mass index (BMI) >35 kg/m2 to make comparisons. Participants found TAS more acceptable than TVS, and two thirds preferred TAS for future care. CONCLUSIONS: TAS provided sufficient information for clinicians to assess medical abortion eligibility without additional tests for most patients. However, the frequency of additional testing was exceedingly close to our predefined noninferiority boundary. Why APNs ordered substantially more additional testing than physicians is unclear. TAS was more acceptable to patients than TVS. IMPLICATIONS: TVS use requires high-level disinfection, which is resource-intensive and thus can be a barrier to care. Instead, TAS can be first-line for most women, reducing resources needed to provide medical abortion. Further research could help to establish gestational age and BMI thresholds beyond which TVS would be a more informative first test. We also need to evaluate whether additional training in using TAS would decrease additional testing.


Assuntos
Aborto Induzido , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Ultrassonografia Pré-Natal/métodos , Adulto , Feminino , Humanos , Masculino , Gravidez , Adulto Jovem
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