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OBJECTIVES: This study aimed to compare effectiveness and safety of cervical preparation with osmotic dilators plus same-day misoprostol or overnight mifepristone prior to dilation and evacuation (D&E). STUDY DESIGN: We conducted a retrospective cohort analysis of 664 patients initiating abortion between 18 and 22 weeks at an ambulatory health center. We abstracted medical record data from two consecutive 12-month periods in 2017 to 2019. All patients received overnight dilators plus: 600 mcg buccal misoprostol 90 minutes before D&E (period 1); 200 mg oral mifepristone at time of dilators (period 2). Our primary outcome was procedure time. We report frequency of patients experiencing any acute complication, defined as unplanned procedure (i.e., reaspiration, cervical laceration repair, uterine balloon tamponade) or hospital transfer and bleeding complications. RESULTS: We observed higher mean procedure time in the mifepristone group (9.7 ± 5.3 minutes vs 7.9 ± 4.4, p = 0.004). After adjusting for race, ethnicity, insurance, body mass index, parity, prior cesarean, prior uterine surgery, gestational age, provider, trainee participation, and long-acting reversible contraception initiation, the difference remained statistically significant (relative change 1.09, 95% CI 1.01, 1.17) but failed to reach our threshold for clinical significance. The use of additional misoprostol was more common in the mifepristone group, but the use of an additional set of dilators was not different between groups. Acute complications occurred at a frequency of 4.1% in misoprostol group and 4.3% in mifepristone group (p = 0.90). CONCLUSIONS: We found procedure time to be longer with adjunctive mifepristone compared to misoprostol; however, this difference is unlikely to be clinically meaningful. Furthermore, the frequency of acute complications was similar between groups. IMPLICATIONS: Overnight mifepristone at the time of cervical dilator placement is a safe and effective alternative to adjuvant same-day misoprostol for cervical preparation prior to D&E and may offer benefits for clinic flow and patient experience.
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Abortivos não Esteroides , Misoprostol , Gravidez , Feminino , Humanos , Misoprostol/efeitos adversos , Mifepristona , Dilatação , Abortivos não Esteroides/efeitos adversos , Estudos Retrospectivos , Segundo Trimestre da GravidezRESUMO
We performed a double-blind, placebo-controlled, randomized noninferiority trial to compare same-day osmotic dilators plus misoprostol with overnight osmotic dilators alone for cervical preparation before dilation and evacuation (D&E) between 16 0/7 and 19 6/7 weeks of gestation. The primary outcome was procedure time. The study was halted early owing to poor accrual. However, the median procedure time was 5.7 minutes in the same-day group compared with 4.2 minutes in the overnight group. The median absolute difference in procedure time was 1.5 minutes, which corresponded to a 35% increase in procedure time (relative difference 35%, one-sided 95% CI -Inf to 52%). Same-day cervical preparation with osmotic dilators plus buccal misoprostol before D&E may be a timely option. Clinical Trial Registration: ClinicalTrials.gov, NCT03002441.
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Abortivos não Esteroides , Aborto Induzido , Misoprostol , Aborto Induzido/métodos , Dilatação , Feminino , Humanos , Gravidez , Segundo Trimestre da GravidezRESUMO
Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users. Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment. Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively. Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy. Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).
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OBJECTIVES: Human Papillomavirus vaccination remains a public health concern. Our primary objective was to examine whether eligible people, in an underimmunized population, seeking abortion find the abortion visit an acceptable opportunity to receive the Human Papillomavirus (HPV) vaccine. Our secondary objectives include comparing vaccine acceptors to vaccine decliners on knowledge and attitudinal factors related to the HPV vaccine. STUDY DESIGN: We conducted a cross sectional study in which we offered free HPV vaccine series initiation and completion to eligible patients presenting for abortion services at an outpatient health center. We administered surveys to both vaccine acceptors and decliners, to assess utilization of health services, knowledge of the HPV vaccine, and reasons for not having initiated or completed the vaccine series previously. RESULTS: 101 study participants were offered HPV vaccination; 50 participants accepted and 51 participants declined. All participants completed the survey. Seven of fifty vaccine acceptors completed the vaccine series. Vaccine acceptance was associated with new knowledge that HPV causes cervical cancer. (acceptors = 72.0%, decliners = 52.9%, p = 0.05) The most common reason among both groups for not previously initiating the vaccine was "No one offered it to me" (acceptors = 58.0%, decliners = 53.5%, p = 0.46). A considerable number of participants had not previously heard of the HPV vaccine, 44% of those who accepted, and 35.3% of those who declined (p = 0.64) vaccination at the time of their abortion. CONCLUSION: The abortion visit offers an important opportunity to start or to finish the HPV vaccine series. Most patients are receptive to receiving additional services and were never previously offered the HPV vaccine. Practices and policies aimed at utilizing missed opportunities for HPV vaccine catch up can increase HPV vaccine prevalence among young adult women to reduce lifetime risk for cervical cancer. IMPLICATIONS: The abortion visit may be an opportunity for HPV vaccination catch up in an underimmunized population. Abortion providers may consider offering patients other preventive health care services.
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Aborto Induzido , Infecções por Papillomavirus , Vacinas contra Papillomavirus , Neoplasias do Colo do Útero , Estudos Transversais , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Cidade de Nova Iorque , Infecções por Papillomavirus/prevenção & controle , Aceitação pelo Paciente de Cuidados de Saúde , Gravidez , Neoplasias do Colo do Útero/prevenção & controle , Vacinação , Adulto JovemRESUMO
Purpose: We assessed differences in receipt of cervical cancer screening and completion of the human papillomavirus (HPV) vaccine series between sexual minority and non sexual minority women by using two sub-constructs of sexual orientation-gender of sexual partners and anatomy of sexual partners. Methods: We employed a serial cross-sectional design by using medical record data from August 2012 through August 2016 from an urban health center to compare receipt of cervical cancer screening and completion of the HPV vaccine series. In Wave 1 of the study, gender of sexual partners was the construct used. In Wave 2 of the study, anatomy of sexual partners was the construct used. Multivariable logistic regression analyses were conducted to determine the odds of being up-to-date on cervical cancer screening and completion of the HPV vaccine series among sexual minority women compared with non sexual minority women, with n = 729 in Wave 1 and n = 740 in Wave 2 of the study. Results: Sexual minority women in Wave 2 were significantly less likely to be up-to-date on cervical cancer screening than non sexual minority women (odds ratio = 0.457, p = 0.012, 95% confidence interval 0.248-0.843). We did not find a statistically significant association between receipt of cervical cancer screening and sexual minority status in Wave 1. No significant association between sexual minority status and completion of the HPV vaccine series was found in either Wave. Conclusion: This study provides important information for clinicians and researchers regarding a disparity in cervical cancer screening practices among sexual minority women, utilizing a novel approach for identifying these women.
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Detecção Precoce de Câncer , Vacinas contra Papillomavirus/administração & dosagem , Comportamento Sexual , Minorias Sexuais e de Gênero/estatística & dados numéricos , Vacinação , Adulto , Estudos Transversais , Feminino , Humanos , Infecções por Papillomavirus/prevenção & controle , Neoplasias do Colo do Útero/diagnósticoRESUMO
Purpose: Transgender individuals experience barriers to healthcare, including discrimination in care provision and lack of knowledge about transgender health. We assessed New York City (NYC) transgender and gender nonconforming individuals' sexual and reproductive health (SRH) needs, access to services, and interest in receiving services from Planned Parenthood of NYC (PPNYC). Methods: We conducted an anonymous Internet-based survey of transgender individuals residing in NYC from September to December 2014 by using snowball sampling. Results: Data were analyzed from 113 surveys. Although 74% (71/96) of respondents avoided or delayed healthcare in the past year, most respondents adhered to medically indicated SRH screenings. In the past year, 64% (45/70) and 67% (46/69) of respondents were tested for HIV and other sexually transmitted infections, respectively. In the past 3 years, 80% (39/49) of respondents received clinical breast/chest examinations and 83% (35/42) of eligible individuals received Pap tests. Respondents most often received care at LGBT specialty clinics (35% [37/105]) or at private doctors' offices (31% [32/105]). Eighteen percent (19/107) had ever been to a Planned Parenthood health center. On a four-point scale, respondents rated the following factors as most influential on whether they would seek care at PPNYC: assurance that staff received transsensitivity training (mean 3.8), the existence of gender identity nondiscrimination policies (mean 3.7), and the availability of transgender-specific services, such as hormone therapy (mean 3.7). Conclusions: Although the majority of transgender individuals in our sample received recommended SRH screenings, respondents reported barriers to accessing needed medical care. Healthcare organizations interested in better serving the transgender community should ensure a high level of training around transsensitivity and explore the provision of transgender-specific services.
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OBJECTIVE: To estimate whether follow-up with serum human chorionic gonadotropin (hCG) results in fewer unplanned visits and interventions than follow-up with ultrasonography. METHODS: Women were randomized to either in-clinic serum hCG or ultrasound follow-up after medical abortion. The primary outcome, unplanned interventions and visits, was measured as a composite binary outcome including: additional clinic or emergency room visits, repeat dosing of misoprostol, and surgical evacuation of the uterus. Surveys were administered at initial follow-up and again 1 month after abortion to inquire about unscheduled visits, interventions, and patient satisfaction. Medical records were reviewed for evidence of additional interventions and visits. RESULTS: A total of 376 patients was randomized. Most participants were white (56%), single (83%), nulliparous (63%), and had completed high school (96%). Average participant age was 26±6 years and average gestational age was 46±6 days. Within 2 weeks of abortion, there was no significant difference in the rate of unplanned interventions and visits between arms, 8.2% (13/159) in the serum hCG arm compared with 6.6% (10/151) in the ultrasound arm (relative risk 1.23, 95% confidence interval [CI] 0.56-2.73, P=.60). By 4 weeks postabortion, 4.4% (6/135) in the ultrasound arm and 1.4% (2/142) in the hCG arm had undergone surgical evacuation (relative risk 0.32, 95% CI 0.07-1.54, P=.16). The majority in both the serum hCG (88%) and ultrasound (95%) arms was satisfied with their assigned follow-up method. CONCLUSION: Medical abortion follow-up with serum hCG does not reduce the rate of unplanned interventions and visits compared with ultrasonography. Overall, the number of unplanned interventions is low and both methods of follow-up are acceptable to women.
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Aborto Induzido , Assistência ao Convalescente/estatística & dados numéricos , Gonadotropina Coriônica/sangue , Ultrassonografia , Adulto , Feminino , Humanos , Gravidez , Adulto JovemRESUMO
The purpose of this study is to describe the knowledge and attitudes regarding abortion of a sample of health professionals in Mexico. In particular, we aim to explore their association with the practice of abortion and the care of post-abortion complications, taking into consideration the present legal framework in Mexico. The data come from an anonymous and computerized survey applied to participants attending a national meeting of gynecology and obstetrics in Mexico in 2009 (n=418). The attitudes of health professionals in relation to abortion play a key role in promoting access to both medical and surgical abortion services. We did not find a statistical association between living in a largely restrictive federal entity and the practice of abortions, which may be explained by the lack of knowledge that these survey participants had about abortion laws in their federal entity. This lack of knowledge about abortion legislation can hinder a woman's access to these services even when the legal framework such access.
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Aborto Induzido , Atitude do Pessoal de Saúde , Competência Clínica , Acessibilidade aos Serviços de Saúde , Padrões de Prática Médica/estatística & dados numéricos , Aborto Induzido/legislação & jurisprudência , Aborto Induzido/estatística & dados numéricos , Adulto , Estudos Transversais , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Modelos Logísticos , Masculino , México , Análise Multivariada , Complicações Pós-Operatórias/terapia , Gravidez , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Little is known about abortion practice in Mexico postlegalization of abortion in Mexico City in 2007. STUDY DESIGN: In 2009, we anonymously surveyed 418 Mexican health care providers at the Colegio Mexicano de Especialistas en Ginecologia y Obstetricia meeting using audio computer-assisted self-interview technology. RESULTS: The majority of respondents were obstetrician gynecologists (376, 90%), Catholic (341, 82%), 35-60 years old (332, 79%) and male (222, 53%) and worked with trainees (307, 74%). Prior to 2007, 11% (46) and 17% (71) provided medical and surgical abortions; now, 15% (62) and 21% (86) provide these services, respectively. Practitioners from Mexico City were more likely to provide services than those from other areas. Most medical abortion providers (50, 81%) used ineffective protocols. Surgical abortion providers mainly used either manual vacuum aspiration (39, 45%) or sharp curettage (27, 32%). Most abortion providers were trained in residency and wanted more training in medical (54, 87%) and surgical (59, 69%) abortion. Among nonproviders, 49% (175) and 27% (89) expressed interest in learning to perform medical and surgical abortion, respectively. CONCLUSION: Given the interest in learning to provide safe abortion services and the prevalent use of ineffective medical abortion regimens and sharp curettage, abortion training in Mexico should be strengthened.
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Aborto Induzido/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , Aborto Induzido/legislação & jurisprudência , Aborto Induzido/psicologia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , México , Pessoa de Meia-Idade , Adulto JovemRESUMO
BACKGROUND: The primary purpose of this study was to evaluate whether women undergoing medical abortion can accurately assess abortion outcome based on symptoms alone. Our secondary aim was to identify predictors of medical abortion failure. STUDY DESIGN: We conducted a case-control study of women undergoing medical abortion from January 1, 2004, to December 31, 2005, who were 63 days' gestation or less and received 200 mg mifepristone followed by 800 mcg of vaginal misoprostol 6-72 h later. Cases were defined as women who required uterine evacuation for a retained gestational sac or ongoing pregnancy. Separate analyses were conducted for the subset of cases with ongoing pregnancies. Controls were defined as women who successfully expelled the pregnancy without uterine evacuation. RESULTS: During the study period, 53 women had a retained gestational sac (N = 26) or ongoing pregnancy (N = 27), and a total of 53 controls were selected, matched by site and date of procedure. Case subjects were more likely than controls to report minimal vaginal bleeding and ongoing pregnancy symptoms and to express doubt that they expelled the pregnancy. When predictive modeling was performed, ongoing pregnancy symptoms, minimal bleeding and gestational age as determined by ultrasound measurement of gestational sac or crown-rump length accurately identified only 68% of medical abortion failures. We also found that the odds of medical abortion failure decreased progressively from approximately 4 to 7 weeks' gestational age, was lowest at approximately 7 weeks and increased from 7 to 9 weeks' gestation. CONCLUSION: Patient symptomatology and self-assessment of complete abortion alone are moderately useful in identifying medical abortion failure. An objective measure of complete abortion, such as a pregnancy test, is still required.
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Aborto Induzido , Autoavaliação Diagnóstica , Abortivos Esteroides , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Mifepristona , Misoprostol , Gravidez , Estudos Retrospectivos , Falha de Tratamento , Adulto JovemRESUMO
BACKGROUND: Pharmacies are important sites for access to health information and medications in Mexico. Most workers are not trained in health issues and may provide inaccurate information to consumers. Misoprostol is used by women throughout Mexico for early abortion and often is purchased from pharmacies. This study aims to understand the practices of pharmacy workers when asked for advice about and medications for abortion, in particular misoprostol. STUDY DESIGN: A random sample of pharmacies in both urban and rural areas of one state of Mexico included both chain and independent pharmacies (n=169). Two mystery clients (MCs) visited the pharmacies, requesting medication for "bringing down the period" and then asking for misoprostol. MCs recorded information about the interactions following each visit in standardized formats. Bivariate comparisons were made between spontaneous and prompted discussions of misoprostol. Associations were considered statistically significant at alpha<.05. RESULTS: Ninety percent of pharmacy workers attending to the MCs discussed misoprostol as an abortifacient, either spontaneously or after being prompted by the MCs. Misoprostol was for sale in most (61%) of these pharmacies. The majority of pharmacy workers (75%) did not request a prescription. Over 75% of all pharmacy workers provided the MCs referral to trained medical providers with whom they could seek a follow-up visit. Sixteen percent of pharmacy workers suggested a regimen consistent with evidence and recommendations for using misoprostol for early abortion. Regimens that were underdosages were common, and few workers recommended a potentially harmful overdosage. Instructions about side effects and risks were rare. The price of misoprostol ranged from 900 to 1800 pesos (US$83-167) for a bottle of 28 tablets (200 mcg each) or US$4.07 per tablet, on average. CONCLUSIONS: Pharmacy workers in both urban and rural areas of Mexico are increasingly becoming aware of misoprostol as an effective abortifacient and are willing to provide the information to consumers. However, their information is limited and often inaccurate. Strategies need to be developed so that they receive timely and correct information, consistent with evidence-based recommendations. The legal context of abortion in Mexico (with restrictions in every state, except Mexico City), the restricted registration of misoprostol as a therapeutic agent only for gastric ulcers and the fact that the majority of pharmacy workers are not considered to be health workers are among the most important barriers to advances in training pharmacy workers in the correct application of misoprostol.
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Abortivos não Esteroides/uso terapêutico , Aborto Induzido/métodos , Misoprostol/uso terapêutico , Farmácias , Aborto Induzido/educação , Adulto , Feminino , Humanos , Masculino , México , Automedicação/métodosRESUMO
El objetivo de este estudio es describir los conocimientos y actitudes de una muestra de profesionales médicos en México con relación al aborto y su asociación con la práctica y la atención a complicaciones derivadas de abortos, tomando en cuenta el marco legal vigente. Los datos provienen de una encuesta anónima y computarizada a participantes que acudieron a una reunión de gineco-obstetricia en México en 2009 (n=418). Las actitudes de los profesionales de la salud juegan un papel determinante para favorecer el acceso a servicios de abortos tanto médicos como quirúrgicos. No se encontró asociación estadística entre vivir en una entidad federativa mayormente restrictiva y la práctica de abortos, lo cual se explica por el escaso conocimiento que los participantes de la encuesta tenían sobre las leyes de aborto vigentes en su entidad. Esta falta de conocimiento sobre la legislación del aborto puede obstaculizar que una mujer tenga este servicio aun cuando el marco legal lo permita.
The purpose of this study is to describe the knowledge and attitudes regarding abortion of a sample of health professionals in Mexico. In particular, we aim to explore their association with the practice of abortion and the care of post-abortion complications, taking into consideration the present legal framework in Mexico. The data come from an anonymous and computerized survey applied to participants attending a national meeting of gynecology and obstetrics in Mexico in 2009 (n=418). The attitudes of health professionals in relation to abortion play a key role in promoting access to both medical and surgical abortion services. We did not find a statistical association between living in a largely restrictive federal entity and the practice of abortions, which may be explained by the lack of knowledge that these survey participants had about abortion laws in their federal entity. This lack of knowledge about abortion legislation can hinder a woman's access to these services even when the legal framework such access.