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1.
Contraception ; 107: 29-35, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34529952

RESUMO

OBJECTIVE: To evaluate whether same-day administration of mifepristone and misoprostol, compared with misoprostol alone, reduces the duration of second-trimester induction of labor for termination of pregnancy or increases the rate of fetal expulsion within 24 hours. STUDY DESIGN: We conducted a retrospective analysis of patients undergoing induction of labor for pregnancy termination in the second trimester between 2009 and 2018. We compared patients who received mifepristone on the same day as the first dose of misoprostol to those who received misoprostol alone. The primary outcome was expulsion within 24 hours after the first dose of misoprostol. RESULTS: Two hundred ninety-eight patients met criteria for inclusion, of whom 94 (31.5%) received same-day mifepristone. Expulsion within 24 hours occurred in 93.6% of the mifepristone-plus-misoprostol group and 79.9% of the misoprostol-only group (RR 1.17, 95%CI 1.07-1.28). Expulsion within 12 hours occurred in 56.4% of the mifepristone-plus-misoprostol group and 34.0% of the misoprostol-only group (RR 1.66, 95%CI 1.28-2.16). After adjusting for demographic and clinical characteristics, the rate of expulsion within 24 hours was similar between groups (RR 1.07, 95%CI 0.92-1.26), while the rate of expulsion within 12 hours remained different (RR 1.69, 95%CI 1.01-2.83). Median time to expulsion was shorter in the mifepristone-plus-misoprostol group than the misoprostol-only group (689 minutes vs 901 minutes, p < 0.001). CONCLUSION(S): Patients who received mifepristone on the same day as misoprostol had a shorter duration of induction termination and higher rate of success within 12 hours.


Assuntos
Abortivos não Esteroides , Abortivos Esteroides , Aborto Induzido , Misoprostol , Feminino , Humanos , Mifepristona/farmacologia , Gravidez , Segundo Trimestre da Gravidez , Estudos Retrospectivos
2.
J Am Pharm Assoc (2003) ; 61(6): 785-794.e1, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34281806

RESUMO

BACKGROUND: The U.S. Food and Drug Administration (FDA) restricts dispensing of mifepristone for medication abortion to certified health care providers at clinical facilities, thus prohibiting pharmacist dispensing. Allowing mifepristone dispensing by pharmacists could improve access to medication abortion. OBJECTIVE: To assess the feasibility of pharmacists dispensing mifepristone to patients who have undergone evaluation for eligibility and counseling for medication abortion by a clinician. METHODS: Before providing a study training on medication abortion, we administered baseline surveys to pharmacists who participated in a multisite mifepristone-dispensing intervention. The survey assessed medication abortion knowledge-using a 15-item score-and perceptions about the benefits and challenges of the model. We administered follow-up surveys in the study's final month that also assessed the pharmacists' satisfaction and experiences with mifepristone dispensing. To investigate the association of the study intervention with the pharmacists' knowledge, perceptions, and experiences dispensing mifepristone, we conducted multivariable linear regression analyses using generalized estimating equation models, accounting for clustering by individual. RESULTS: Among the 72 pharmacists invited from 6 pharmacies, 47 (65%) completed the baseline surveys, and 56 (78%) received training. At the study's end (mean 18 months later), 43 of the 56 pharmacists who received training (77%) completed the follow-up surveys. At follow-up, 36 (83%) respondents were very or somewhat satisfied with mifepristone dispensing, and 24 (56%) reported experiencing no challenges dispensing mifepristone. Four (6%) of the 72 pharmacists invited objected to participating in mifepristone dispensing. In regression analyses, average knowledge scores, perceived ease of implementation, and level of support for the pharmacist-dispensing model were higher at follow-up (P < 0.001). CONCLUSION: Most pharmacists were willing to be trained, dispensed mifepristone with few challenges when given the opportunity, were satisfied with the model, and had higher knowledge levels at follow-up. Our findings support removal of FDA's restriction on pharmacist dispensing of mifepristone.


Assuntos
Aborto Induzido , Farmácias , Feminino , Pessoal de Saúde , Humanos , Mifepristona , Farmacêuticos , Gravidez
3.
Obstet Gynecol ; 137(4): 613-622, 2021 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-33706339

RESUMO

OBJECTIVE: To estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists. METHODS: We conducted a prospective cohort study at eight clinical sites and pharmacies in California and Washington State from July 2018 to March 2020. Pharmacists at participating pharmacies underwent a 1-hour training on medication abortion. We approached patients who had already been evaluated, counseled, and consented for medication abortion per standard of care. Patients interested in study participation gave consent, and the clinician electronically sent a prescription to the pharmacy for mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 800 micrograms buccally. Participants were sent web-based surveys about their experience and outcomes on days 2 and 14 after enrollment and had routine follow-up with study sites. We extracted demographic and clinical data, including abortion outcome and adverse events, from medical records. We performed multivariable logistic regression to assess the association of pharmacy experience and other covariates with satisfaction. RESULTS: We enrolled 266 participants and obtained clinical outcome information for 262 (98.5%), of whom two reported not taking either medication. Of the 260 participants with abortion outcome information, 252 (96.9%) and 237 (91.2%) completed day 2 and 14 surveys, respectively. Complete medication abortion (primary outcome) occurred for 243 participants (93.5%, 95% CI 89.7-96.1%). Four participants (1.5%, 95% CI 0.4-3.9%) had an adverse event, none of which was serious or related to pharmacist dispensing. In the day 2 survey, 91.3% (95% CI 87.1-94.4%) of participants reported satisfaction with the pharmacy experience. In the day 14 survey, 84.4% (95% CI 79.1-88.8%) reported satisfaction with the medication abortion experience. Those reporting being very satisfied with the pharmacy experience had higher odds of reporting overall satisfaction with medication abortion (adjusted odds ratio 2.96, 95% CI 1.38-6.32). CONCLUSION: Pharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03320057.


Assuntos
Abortivos não Esteroides , Aborto Induzido , Misoprostol , Padrões de Prática dos Farmacêuticos/estatística & dados numéricos , Adolescente , Adulto , California , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Assistência Farmacêutica , Gravidez , Estudos Prospectivos , Inquéritos e Questionários , Telemedicina , Washington , Adulto Jovem
5.
SAGE Open Med ; 9: 2050312120986731, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33489232

RESUMO

OBJECTIVES: To describe leukocytosis trends during cervical preparation with osmotic dilators for second-trimester dilation and evacuation procedures, and to determine whether there is a difference in leukocytosis seen with laminaria versus Dilapan-S. METHODS: We conducted a retrospective cohort study of 986 women presenting for dilation and evacuation from April 2008 through March 2009 at an outpatient clinic network. We included all procedures at ⩾14 weeks' gestation where laminaria or Dilapan-S dilators were used for overnight dilation. All women had routine white blood cell testing during the study period. RESULTS: There was a median increase of 2.4 × 103/µL white blood cell count (95% confidence interval 2.2-2.7 × 103/µL) from beginning of cervical preparation to the day of procedure (95% confidence interval and p value). Women receiving laminaria (n = 805) versus Dilapan-S (n = 181) had a greater increase in white blood cell count from baseline (median increase 2.7 versus 1.2 × 103/µL, p < 0.001), including when adjusting for age, gestational age, parity, baseline white blood cell count, and number of dilators placed. CONCLUSION: There is increased leukocytosis during the course of cervical preparation with osmotic dilators, and this is increased with use of laminaria versus Dilapan-S. Rates of clinically recognized infection in second-trimester abortion are low regardless of dilator type used.

6.
Expert Opin Drug Deliv ; 17(6): 743-752, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32410464

RESUMO

INTRODUCTION: The segesterone acetate and ethinyl estradiol contraceptive vaginal ring (SA/EE CVR) was FDA-approved in August 2018 and is now available in the U.S. The CVR is placed vaginally for 21 days followed by a 7-day ring-free interval, when withdrawal bleeding typically occurs. One ring can be used for up to a year (13 cycles). AREAS COVERED: This review summarizes this novel method of contraception, including the delivery system and the hormonal components. We describe the potential market, how it is used, the pharmacokinetic properties of the device, and results of clinical trials including efficacy, bleeding profile, acceptability, and safety. EXPERT OPINION: The SA/EE CVR represents the first long-lasting user-controlled hormonal contraceptive device. The bleeding pattern is highly favorable and consistent over the entire year and is associated with very low discontinuation. Efficacy and safety are similar to other methods of combined hormonal contraceptives. Unscheduled ring removals increase the risk of failure. Further studies are needed to evaluate continuous use of the ring for greater than 21 days, and potential non-contraceptive benefits of the ring such as reduced menstrual bleeding.


Assuntos
Anticoncepcionais Femininos/administração & dosagem , Etinilestradiol/administração & dosagem , Pregnenodionas/administração & dosagem , Anticoncepção , Dispositivos Anticoncepcionais Femininos , Combinação de Medicamentos , Feminino , Humanos , Tecnologia
7.
Am J Obstet Gynecol ; 223(2): 229.e1-229.e8, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32044312

RESUMO

BACKGROUND: An estimated 1.4 million persons in the United States identify as transgender or nonbinary, signifying that their gender identity does not correspond with their assigned sex at birth. Individuals assigned female at birth may seek gender-affirming hormone therapy with testosterone. No studies have directly examined ovulatory function in transmasculine individuals using injectable testosterone. OBJECTIVES: Our primary objective was to determine the effect of testosterone on ovulatory suppression in transmasculine individuals. Secondary objectives were to determine predictors of ovulation in transmasculine individuals on testosterone, and to assess the effect of testosterone on antimüllerian hormone. MATERIALS AND METHODS: This prospective observational study recruited participants from a community clinic that provides gender-affirming hormone therapy. Enrolled individuals were assigned female at birth and were currently using or seeking to initiate masculinizing therapy with injectable testosterone esters (transmasculine individuals). Over a 12-week study period, participants collected daily urine samples for pregnanediol-3-glucoronide testing and completed daily electronic bleeding diaries. We assessed monthly serum mid-dosing interval testosterone, estradiol and sex hormone binding globulin, and antimüllerian hormone values at baseline and study end. Ovulation was defined as pregnanediol-3-glucoronide greater than 5 µg/mL for 3 consecutive days. The primary outcome was the proportion of participants who ovulated during the study period. We examined predictors of ovulation such as age, length of time on testosterone, serum testosterone levels, body mass index, and bleeding pattern. RESULTS: From July to November 2018, we enrolled 32 individuals; 20 completed the study (14 continuing testosterone users, 6 new users). Median age was 23 years (range 18-37 years). Bleeding or spotting during the study period was noted by 41% of participants (13/32). Among continuing users, median testosterone therapy duration was 11 months (range 1-60 months). A single ovulation was observed out of a total of 61 combined months of testosterone use; however, several transient rises in pregnanediol-3-glucoronide followed by bleeding episodes were suggestive of 7 dysfunctional ovulatory cycles among 7 individuals. There was no difference in antimüllerian hormone from baseline to 12 weeks between participants initiating testosterone and continuing users of testosterone. We did not have the power to examine our intended predictors given the low numbers of ovulatory events, but found that longer time on testosterone and presence of vaginal bleeding over 12 weeks were associated with transient rises in pregnanediol-3-glucoronide. CONCLUSION: This study suggests that testosterone rapidly induces hypothalamic-pituitary-gonadal suppression, resulting in anovulation in a proportion of new users. Importantly, these data also suggest that some long-term testosterone users break through the hormonal suppression and experience an ovulatory event, thereby raising concerns pertaining to the need for contraception in transmasculine individuals engaged in sexual intercourse with sperm-producing partners. Given the small number of overall participants, this work is hypothesis generating. Larger studies are needed to confirm and to clarify these findings.


Assuntos
Androgênios/uso terapêutico , Hormônio Antimülleriano/sangue , Disforia de Gênero/tratamento farmacológico , Inibição da Ovulação , Ovulação/urina , Pregnanodiol/análogos & derivados , Procedimentos de Readequação Sexual , Testosterona/uso terapêutico , Pessoas Transgênero , Adolescente , Adulto , Feminino , Humanos , Masculino , Menstruação , Pregnanodiol/urina , Resultado do Tratamento , Adulto Jovem
8.
Menopause ; 27(4): 393-397, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31934951

RESUMO

OBJECTIVE: Depression in women is more common during perimenopause (the time period around and during menopause) than pre and postmenopause. Obstetrician-gynecologists (ob-gyns) play a vital role in the detection and management of depression symptoms in women because for many women ob-gyns are the first and most frequent point of medical contact. This study assessed ob-gyns' screening practices and management of depression in perimenopause. METHODS: A survey regarding depression during perimenopause was sent to 500 practicing ob-gyns who were fellows of the American College of Obstetricians and Gynecologists and members of the Collaborative Ambulatory Research Network. RESULTS: The survey response rate was 41.8% (209 of 500 surveys returned). Over a third of respondents (34.1%) reported that they did not regularly screen perimenopausal patients for depression. Higher-quality education about depression, respondent sex, and personal experience with depression were associated with higher rates of screening. While 85.7% of respondents believed that they could recognize depression in perimenopausal women, only about half (55.8%) were confident in their ability to treat these patients. CONCLUSION: Increased education of ob-gyn physicians related to depression during perimenopause may increase the screening and treatment of women during this phase of life.


Assuntos
Depressão/diagnóstico , Conhecimentos, Atitudes e Prática em Saúde , Programas de Rastreamento/estatística & dados numéricos , Perimenopausa , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Idoso , Depressão/terapia , Feminino , Ginecologia/educação , Ginecologia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Obstetrícia/educação , Obstetrícia/métodos , Inquéritos e Questionários
9.
Sex Med ; 7(2): 198-206, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30833227

RESUMO

INTRODUCTION: More than one-third of women in the U.S. have engaged in heterosexual anal intercourse (HAI), but little is known regarding women's perceptions of HAI and motivations for engaging in this sexual behavior. AIM: This study aimed to explore U.S. women's motivations for engaging in HAI and to investigate how they navigate HAI in the context of sexual relationships. METHODS: Semi-structured interviews were conducted with 20 women, ages 18-50 years old, who had engaged in anal intercourse with a male partner within the past 3 months. The interview guide was developed utilizing a conceptual framework based on the Theory of Planned Behavior. MAIN OUTCOME MEASURE: Thematic content analysis was performed, and salient themes were identified. RESULTS: Salient themes were identified in all key components of the construct, including attitudes toward the behavior, subjective norms, and perceived behavioral control. Women's intent to engage in HAI was influenced by their attitudes toward HAI and level of control and trust with their partners. Primary motivators were partner and personal pleasure and sexual curiosity and experimentation. CONCLUSION: The Theory of Planned Behavior construct was well suited to explore factors influencing women's intent to engage in HAI. Most women perceive negative societal norms toward HAI. Although this does not appear to affect intention to engage in HAI, it does affect disclosure of this sexual activity with friends and healthcare providers. It is important for healthcare providers to provide open, non-judgmental counseling regarding HAI to decrease stigma, enhance communication, and improve sexual health. Benson LS, Gilmore KC, Micks EA, et al. Perceptions of Anal Intercourse Among Heterosexual Women: A Pilot Qualitative Study. Sex Med 2019;7:198-206.

10.
Obstet Gynecol ; 128(5): 1065-1070, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27741198

RESUMO

OBJECTIVE: To evaluate the relationship between obesity and surgical abortion complications in the outpatient setting. METHODS: We conducted a retrospective cohort study of 4,968 women undergoing surgical abortion at a large outpatient clinic network from September 2012 to July 2014. We used log-binomial regression to evaluate body mass index (BMI) as an independent risk factor for first- and second-trimester abortion complications. Body mass index was analyzed as both a continuous and categorical predictor. We assessed complications including need for uterine reaspiration (including same-day reaspiration), uterine perforation, cervical laceration, infection, emergency department visit or hospitalization, and excessive blood loss defined as estimated blood loss greater than or equal to 100 mL. RESULTS: The majority (77%) of procedures was performed in the first trimester. Forty-seven percent of women were normal weight or underweight, 28% were overweight, and 25% were obese, including 4% with BMI greater than or equal to 40. The overall complication rate was 1.7%; the most common complications were need for uterine reaspiration (1.0%) and excessive blood loss (0.6%). Obesity was not associated with increased risk of surgical complications, including when adjusting for age, gestational age, and history of prior cesarean delivery. CONCLUSION: In a high-volume outpatient abortion clinic with experienced health care providers, abortion is very safe. Obesity does not appear to be an independent predictor for abortion complications and should not be used in isolation to refer women to hospital-based facilities for abortion care in the first or second trimester.


Assuntos
Aborto Terapêutico/efeitos adversos , Obesidade/complicações , Complicações Pós-Operatórias , Adulto , Assistência Ambulatorial , Estudos de Coortes , Feminino , Humanos , Gravidez , Primeiro Trimestre da Gravidez , Segundo Trimestre da Gravidez , Estudos Retrospectivos , Fatores de Risco , Segurança
11.
Womens Health (Lond) ; 11(6): 769-77, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26626698

RESUMO

Permanent methods of contraception are used by an estimated 220 million couples worldwide, and are often selected due to convenience, ease of use and lack of side effects. A variety of tubal occlusion techniques are available for female permanent contraception, and procedures can be performed using a transcervical or transabdominal approach. This article reviews currently available techniques for female permanent contraception and discusses considerations when helping patients choose a contraceptive method and tubal occlusion technique.


Assuntos
Anticoncepção/métodos , Esterilização Tubária , Feminino , Humanos , Gravidez , Reversão da Esterilização
12.
Obstet Gynecol Clin North Am ; 42(4): 669-81, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26598308

RESUMO

Combined hormonal contraceptives (CHCs) have traditionally been prescribed in 28-day cycles, with 21 days of active hormones followed by a 7-day hormone-free interval. Extended and continuous CHC regimens, defined as regimens with greater than 28 days of active hormones, offer many benefits, including a decrease in estrogen-withdrawal symptoms and likely greater efficacy because of more reliable ovulation suppression. Bleeding profiles are favorable, and unscheduled bleeding decreases over time with these regimens. Extended and continuous regimens of combined oral contraceptives and the contraceptive vaginal ring are safe and have high user acceptability and satisfaction. However, despite numerous benefits, extended and continuous CHC regimens are underused.


Assuntos
Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Hormonais/administração & dosagem , Serviços de Planejamento Familiar , Dispositivos Intrauterinos Medicados/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos , Ciclo Menstrual/efeitos dos fármacos , Adesivo Transdérmico/estatística & dados numéricos , Adulto , Esquema de Medicação , Feminino , Humanos , Ciclo Menstrual/fisiologia , Menstruação/efeitos dos fármacos , Menstruação/fisiologia , Satisfação do Paciente/estatística & dados numéricos , Estados Unidos
13.
J Pediatr Adolesc Gynecol ; 27(6): 353-5, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25256877

RESUMO

STUDY OBJECTIVE: The purpose of this case series was to evaluate the efficacy and complication rate with use of long-acting reversible contraceptive (LARC) methods in adolescents with cardiovascular conditions. DESIGN AND PARTICIPANTS: We performed a retrospective chart review of adolescents age 22 or younger with congenital cardiac anomalies or major cardiovascular conditions who had a LARC device placed at Seattle Children's Hospital or University of Washington Medical Center between January 1, 2007 and March 1, 2012. MAIN OUTCOME MEASURES: Patient characteristics, medical conditions, indications, and complications including perforation, pregnancy, expulsion, and pelvic infection were collected and analyzed. RESULTS: Thirty adolescents with congenital cardiac anomalies or other cardiovascular conditions had a LARC device inserted during the study period. Mean age at placement was 17.7 years (range 12-22). Twelve patients (40%) had reported a previous pregnancy and 12 (40%) had never been sexually active at time of placement. Common primary and secondary indications were desired contraception (22 patients, 73%), desired menstrual suppression (15 subjects, 50%) and treatment of heavy menstrual bleeding (8 subjects, 27%). Twenty-nine patients had a structural cardiac anomaly. There were 27 levonorgestrel-releasing intrauterine devices (IUD), 1 copper IUD, and 3 etonogestrel implants placed. There were 2 confirmed IUD expulsions and 1 removal due to persistent irregular bleeding and cramping. There were no cases of pelvic inflammatory disease or pregnancies with LARC methods in place. Twenty-seven (90%) patients were continuing LARC at last follow-up. CONCLUSIONS: In this small case series of adolescents with cardiovascular conditions, LARC devices were effective at pregnancy prevention without serious complications.


Assuntos
Doenças Cardiovasculares , Anticoncepcionais Femininos/administração & dosagem , Dispositivos Intrauterinos Medicados , Levanogestrel/administração & dosagem , Adolescente , Doenças Cardiovasculares/complicações , Anticoncepção/métodos , Desogestrel/administração & dosagem , Implantes de Medicamento , Feminino , Humanos , Expulsão de Dispositivo Intrauterino , Dispositivos Intrauterinos de Cobre , Dispositivos Intrauterinos Medicados/efeitos adversos , Menorragia/terapia , Estudos Retrospectivos , Adulto Jovem
14.
Contraception ; 90(1): 60-5, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24794720

RESUMO

OBJECTIVE: Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroglycerin gel applied vaginally 30 min prior to IUD placement would reduce insertion-related pain. STUDY DESIGN: We designed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 0.5-mg nitroglycerin gel (1 mL) or identical placebo gel applied vaginally in nulliparous women 30 min prior to IUD placement. The study was limited to women who opted for the levonorgestrel-releasing intrauterine system. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with passage of the IUD through the cervix. Secondary outcomes included subject-reported pain at other time points, provider-reported ease of insertion, side effects, adverse events and need for additional dilation. RESULTS: A total of 24 women were randomized. Baseline characteristics were similar between groups. The mean pain score with IUD deployment was 55.0 mm [standard deviation (SD) = 29.7 mm] in the placebo group and 57.4 mm (SD 22.1 mm) in the nitroglycerin group (p=.82). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group. CONCLUSION: Vaginal administration of 0.5-mg nitroglycerin gel 30 min prior to IUD placement does not appear to decrease patient-reported procedural pain among nulliparous women or ease of insertion for providers.


Assuntos
Dispositivos Intrauterinos Medicados , Nitroglicerina/administração & dosagem , Dor/tratamento farmacológico , Vasodilatadores/administração & dosagem , Administração Intravaginal , Adulto , Método Duplo-Cego , Feminino , Humanos , Levanogestrel/administração & dosagem , Pessoa de Meia-Idade , Medição da Dor/métodos , Projetos Piloto , Adulto Jovem
15.
Contraception ; 89(3): 229-33, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24405796

RESUMO

OBJECTIVE: Although previous studies have demonstrated that a variety of local anesthetics are effective to decrease pain associated with tenaculum placement, no studies directly compare an injection with a topical anesthetic. The objective of this study was therefore to compare mean pain scores with tenaculum placement after an intracervical lidocaine injection or topical lidocaine gel. STUDY DESIGN: A randomized, single-blinded trial of women presenting for office gynecologic procedures that required a tenaculum. Women aged 18 years or older were randomized to receive either a 1% lidocaine intracervical injection or topical application of 2% lidocaine gel to the cervix immediately prior to tenaculum placement. The primary outcome was pain at the time of tenaculum placement, measured on a 100 mm Visual Analog Scale. Secondary outcomes included pain with the intervention and satisfaction with tenaculum placement. RESULTS: Seventy-four women were enrolled and randomized; 35 subjects in each group met criteria for analysis. The two groups had similar socio-demographic characteristics. Women who received the injection had lower mean pain levels at tenaculum placement [12.3 mm (S.D. 17.4 mm) versus 36.6 mm (S.D. 23.0 mm), p<.001] but higher mean pain levels with study drug application [20.4 mm (S.D. 19.4 mm) versus 5.9 mm (S.D. 8.6 mm), p<.001]. Satisfaction with tenaculum placement was similar for the two groups. CONCLUSION: Mean pain with tenaculum placement is lower after receiving a lidocaine injection than after receiving a topical lidocaine gel. Satisfaction with tenaculum placement is similar with both interventions.


Assuntos
Analgesia/métodos , Procedimentos Cirúrgicos em Ginecologia/instrumentação , Ginecologia/instrumentação , Ginecologia/métodos , Manejo da Dor , Adulto , Anestésicos Locais/administração & dosagem , Colo do Útero/efeitos dos fármacos , Feminino , Humanos , Histeroscópios , Dispositivos Intrauterinos , Lidocaína/administração & dosagem , Medição da Dor , Método Simples-Cego
16.
Contraception ; 87(4): 421-5, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23218853

RESUMO

BACKGROUND: Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroprusside gel applied intracervically prior to IUD placement would reduce insertion-related pain. STUDY DESIGN: We performed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 10-mg nitroprusside gel (1 mL) or identical placebo gel applied intracervically in nulliparous women immediately prior to IUD placement. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with IUD insertion. Secondary outcomes included provider-reported ease of insertion, subject-reported pain at other time points, side effects, adverse events and need for additional dilation. RESULTS: A total of 24 women were randomized. Baseline characteristics were similar between groups. The mean pain score with IUD deployment was 73 mm (SD 17 mm) in the placebo group and 59 mm (SD 26 mm) in the nitroprusside group (p=.15). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group. There were two vasovagal reactions in the nitroprusside group and none in the placebo group. CONCLUSIONS: Intracervical administration of 10-mg nitroprusside gel immediately prior to IUD insertion does not appear to provide a clinically relevant improvement in patient-reported pain with IUD insertion among nulliparous women.


Assuntos
Dispositivos Intrauterinos/efeitos adversos , Doadores de Óxido Nítrico/uso terapêutico , Nitroprussiato/uso terapêutico , Dor/prevenção & controle , Adulto , Método Duplo-Cego , Feminino , Humanos , Paridade , Projetos Piloto , Gravidez , Cuidados Pré-Operatórios/métodos , Adulto Jovem
17.
Adv Ther ; 30(1): 1-13, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23239397

RESUMO

The new estradiol valerate and dienogest oral contraceptive pill recently received U.S. Food and Drug Administration (FDA) approval to treat heavy menstrual bleeding in women without diagnosed uterine conditions.This oral contraceptive formulation combines estradiol valerate, which is metabolically identical to natural estradiol, with the potent new progestin, dienogest. The four-phasic pill is effective for pregnancy prevention and leads to significantly decreased menstrual bleeding among women with heavy periods, and shorter and lighter periods among women with normal periods. Studies indicate that this formulation may be associated with decreased hepatic activation compared to contraceptive pills that contain ethinyl estradiol. However, whether these findings translate to a decreased risk of thrombotic events has not been determined, and the pill carries the same contraindications as all other combined hormonal contraceptives.At least 10-15% of women suffer from heavy menstrual bleeding, defined as ≥80 mL of blood loss per cycle. In large clinical trials of women with heavy menstrual bleeding, the estradiol valerate and dienogest pill decreased blood loss volume by a median of 81%.Women with heavy menstrual bleeding treated with this contraceptive pill can expect a significant reduction in bleeding after just one cycle of use. This therapy leads to a decrease in bleeding that may be greater than that achieved by different oral contraceptive pills or other medical therapies, including tranexamic acid and nonsteroidal anti-inflammatory drugs.


Assuntos
Anticoncepcionais Orais/uso terapêutico , Estradiol/análogos & derivados , Menorragia/tratamento farmacológico , Nandrolona/análogos & derivados , Combinação de Medicamentos , Estradiol/uso terapêutico , Feminino , Humanos , Nandrolona/uso terapêutico
18.
Obstet Gynecol ; 120(5): 1060-9, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23090523

RESUMO

OBJECTIVE: Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion. METHODS: We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications. RESULTS: There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted. CONCLUSION: Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459. LEVEL OF EVIDENCE: I.


Assuntos
Aborto Induzido , Acetaminofen/uso terapêutico , Analgésicos não Narcóticos/uso terapêutico , Analgésicos Opioides/uso terapêutico , Hidrocodona/uso terapêutico , Manejo da Dor/métodos , Dor Pós-Operatória/tratamento farmacológico , Acetaminofen/efeitos adversos , Adolescente , Adulto , Analgésicos não Narcóticos/efeitos adversos , Analgésicos Opioides/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Hidrocodona/efeitos adversos , Percepção da Dor , Gravidez , Primeiro Trimestre da Gravidez , Adulto Jovem
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