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BACKGROUND: Severe COVID-19 infection in pregnancy has been associated with an increase in adverse perinatal outcomes, although studies differ regarding which outcomes are affected. Increased characterization of obstetrical and neonatal outcomes is needed, including details on indications for preterm delivery and additional neonatal adverse outcomes. OBJECTIVE: This study aimed to determine whether there is a higher rate of adverse perinatal outcomes with severe-to-critical COVID-19 infection compared with nonsevere COVID-19 diagnosed during pregnancy. STUDY DESIGN: This was a retrospective observational cohort study that compared rates of adverse perinatal outcomes between patients with severe-to-critical and those with nonsevere (asymptomatic, mild, or moderate) COVID-19 infection. Patients had singleton pregnancies and a positive laboratory polymerase chain reaction result for COVID-19. Primary outcomes included hypertensive disorders of pregnancy, cesarean delivery, fetal growth restriction, preterm birth, and neonatal intensive care unit admission. Additional neonatal outcomes analyzed included need for cardiopulmonary resuscitation, low birthweight (<2500 g), 1- or 5-minute Apgar score <7, need for supplemental oxygen, need for intubation, intraventricular hemorrhage, sepsis, respiratory distress syndrome, bronchopulmonary dysplasia, blood transfusion, necrotizing enterocolitis, hypoxic-ischemic encephalopathy, birth trauma, or neonatal death. Appropriate bivariate analyses were used to compare groups. Logistic regression was used to examine primary outcomes while adjusting for confounders. RESULTS: A total of 441 participants were identified and confirmed via detailed chart review to be pregnant with a singleton pregnancy while diagnosed with COVID-19. Of these, 44 (10%) met National Institutes of Health criteria for severe-to-critical COVID-19 infection. The median gestational age at the time of maternal COVID-19 diagnosis was 36.4 weeks (interquartile range, 29.6-38.6). Severe-to-critical COVID-19 infection had a higher risk of a composite adverse neonatal outcome (36.4% vs 21.4%; P=.03). There was a high incidence of hypertensive disorders of pregnancy overall (20.6%), but this outcome was not higher in the severe-to-critical vs nonsevere group. There were no maternal deaths. There was a low incidence of neonatal COVID-19 test positivity among those tested (1.8%). When adjusting for presence of heart disease and gestational age at COVID-19 diagnosis, severe-to-critical COVID-19 was strongly associated with fetal growth restriction (adjusted odds ratio, 2.73; confidence interval, 1.03-7.25) and neonatal intensive care unit admission (adjusted odds ratio, 3.50; confidence interval, 1.56-7.87). Preterm delivery was more common but was no longer significant after adjustment (adjusted odds ratio, 2.23; confidence interval, 0.99-5.05). CONCLUSION: Severe-to-critical COVID-19 infection during pregnancy is associated with higher rates of adverse neonatal outcomes and strongly associated with neonatal intensive care unit admission and fetal growth restriction compared with nonsevere disease. There is a high rate of hypertensive disorders of pregnancy overall in all those affected by COVID-19, regardless of severity. Pregnant persons should be counseled on these risks to encourage vaccination, and those with infection during pregnancy should be monitored for fetal growth disorders.
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BACKGROUND: Few cluster-randomized trials have been performed in rural Guatemala. Our objective was to describe the feasibility, recruitment and retention in our cluster-randomized trial. METHODS: In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala. RESULTS: Of 173 women approached, 33 were excluded. Of the 140 eligible women, 127 (91%) consented to participate. Of the 87 women who should have been assessed for the primary outcome, three were lost to follow-up, which represents a retention rate of 97%. CONCLUSIONS: Nurses who are both clinical providers and study staff can feasibly conduct research, which leads to high enrollment and retention rates.
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INTRODUCTION: The aim of this analysis is to present initial contraceptive choices of women offered postpartum contraception in rural Guatemala. METHODS: We trained community nurses participating in the delivery of a home-based antepartum and postpartum care program in rural Guatemala in contraceptive implant placement and had them offer condoms, pills, an injection, or an implant at women's home-based 40-day postpartum visit in intervention clusters of a non-blinded, cluster-randomized trial. Women who had already started postpartum contraception or were over the age of 35 were excluded from participation. The primary outcome of the trial was contraceptive use at 3 months postpartum, so this initial analysis describes immediate preferences in the population. RESULTS: Of 208 women enrolled in the study, 108 were in intervention clusters and 100 lived in control clusters. In the intervention group, 32 women declined contraception, 36 women received the injectable, 30 women had an implant placed, 5 women started pills, 2 women chose condoms, and data on 3 women were missing. In the control clusters, 43 women were planning on the injectable, 11 planned on the implant, 10 did not want to start a method, 5 planned on sterilization, 2 aimed for natural family planning, 2 wanted a copper IUD, 1 woman wanted condoms, 18 did not know, and data on 8 women were missing. DISCUSSION: The contraceptive implant, which was not previously available in this community, had high uptake at 27.8% in the intervention group. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391 Protocol: https://doi.org/10.1186/s13063-019-3735-3.
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Anticoncepção , Anticoncepcionais , Feminino , Guatemala , Humanos , Cuidado Pós-Natal , Período Pós-Parto , GravidezRESUMO
DESIGN: We conducted a secondary analysis of a cluster-randomized trial to observe characteristics associated with women who chose to use long-acting reversible contraceptives (LARC) compared to those who chose a short-acting method 12 months after enrollment. METHODS: The trial studied four control and four intervention clusters where the intervention clusters were offered contraception at their 40-day routine postpartum visit; control clusters received standard care, which included comprehensive postpartum contraceptive counseling. Women were followed through twelve months postpartum. RESULTS: The study enrolled 208 women; 94 (87.0%) were in the intervention group and 91 (91.0%) were in the control group. At twelve months, with 130 (70.3%) women using contraception at that time. 94 women (50.8%) were using a short acting method compared to 33 (17.9%) who chose a long-acting method, irrespective of cluster. In mixed effect regression modeling adjusted for cluster, characteristics associated with a reduced likelihood of choosing long-acting contraception in multivariate modeling included age (aRR 0.98 [0.96,0.99], p = 0.008) and any education (compared to no education; aRR 0.76 [0.60,0.95], p = 0.02). Women who were sexually active by their enrollment visit (40 days postpartum) were 30% more likely to opt for a long-acting method (aRR 1.30 [1.03,1.63], p = 0.03). CONCLUSION: Older and more educated women were less likely to be using LARC a year after enrollment, while women with a history of early postpartum sexual activity were more likely to choose LARC.
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DESIGN: We executed a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with three and 12-month contraceptive utilization, satisfaction, and pregnancy rates. METHODS: Eight clusters were randomized to receive either the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit in addition to routine care, or routine care alone, which included comprehensive contraceptive counseling throughout antepartum care. RESULTS: 208 women were enrolled in the study, 108 in the intervention clusters and 100 in control clusters. 94 (87.0%) women in the intervention group and 91 (91%) of women in control clusters were evaluated 12 months post-enrollment. Likelihood of using contraception at that time was borderline increased in intervention clusters (RR 1.1 [1.0,1.3], p = 0.05) with an increased likelihood of long-acting contraceptive use (the implant; RR 1.6 [1.3,1.9], p < 0.001). Pregnancy rates were also borderline reduced in the intervention clusters (RR 1.0 [1.0,1.1], p = 0.07). There was no difference in satisfaction of women with contraceptive use between arms with about 95% of women very satisfied or a little satisfied in each arm. Continuation rates at twelve months of contraceptives in the intervention group were 0.0% for condom users, 80.0% for contraceptive pill users, 57% for injectable users, and 83% for implant users. Most women who discontinued their initial method chose a more long-term or permanent method. There was a trend toward a significant association with reduced short interval pregnancy. CONCLUSION: Our study had a borderline increase in overall use of contraception by 12 months, did have an increased likelihood of long-acting contraceptive use of the implant by 12 months, and resulted in a trend toward reduced short interval pregnancy in the intervention clusters as compared to control clusters.
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OBJECTIVE: This study aimed to assess the effect that race and socioeconomic factors have on the provision of care to cervical cancer patients based on National Comprehensive Cancer Network (NCCN) recommended treatment guidelines. MATERIALS AND METHODS: To do this, we completed a retrospective cohort study using the American College of Surgeon's Nation Cancer Database from 2004 to 2016. We identified all reported cases of cervical cancer in that period. Two cohorts were created using self-reported racial demographic data, Hispanic- and White, non-Hispanic-identified patients. Our primary outcome variables were adherence to NCCN-recommended treatment and 5-year overall survival. Adherence to NCCN-recommended treatment was determined by the provision of surgical and/or radiation and/or chemotherapy treatment based on the clinical stage at time of diagnosis and the presence or absence of lymphovascular space invasion. We used bivariate analyses to compare baseline characteristics between the 2 cohorts, multivariable logistic regression to identify independent predictors of 5-year survival, and Cox proportional hazards models to compute survival by group. RESULTS: The difference in NCCN-adherent care between the 2 cohorts was found to be not statistically significant (p = .880). A log rank (Mantel-Cox) χ2 test showed that there was a statistically significant difference between the 2 groups in overall survival with the Hispanic-identified patients living longer (p < .001). Our study is limited by the effect large databases confer on finding statistical significance. CONCLUSIONS: Hispanic-identified women with cervical cancer receive NCCN-compliant care and live longer than their White, non-Hispanic counterparts.
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Disparidades em Assistência à Saúde/estatística & dados numéricos , Hispânico ou Latino/estatística & dados numéricos , Cooperação e Adesão ao Tratamento/estatística & dados numéricos , Neoplasias do Colo do Útero/epidemiologia , População Branca/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Bases de Dados Factuais , Etnicidade , Feminino , Fidelidade a Diretrizes , Humanos , Pessoa de Meia-Idade , Qualidade da Assistência à Saúde , Estudos Retrospectivos , Fatores Socioeconômicos , Taxa de Sobrevida , Estados Unidos/epidemiologia , Neoplasias do Colo do Útero/terapia , Adulto JovemRESUMO
DESIGN: This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment. METHODS: In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention. RESULTS: Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4]. CONCLUSION: Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported. TRIAL REGISTRATION: clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.
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Comportamento Contraceptivo , Anticoncepção/estatística & dados numéricos , Anticoncepcionais/uso terapêutico , Serviços de Planejamento Familiar/organização & administração , Acessibilidade aos Serviços de Saúde , Período Pós-Parto , Adulto , Anticoncepção/métodos , Anticoncepcionais/provisão & distribuição , Aconselhamento , Feminino , Guatemala , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Gravidez , Adulto JovemRESUMO
BACKGROUND: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. METHODS: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. DISCUSSION: A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.
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Serviços de Saúde Comunitária , Anticoncepção , Atenção à Saúde , Serviços de Planejamento Familiar , Cuidado Pós-Natal , Serviços de Saúde Rural , Adolescente , Adulto , Feminino , Guatemala , Enfermagem Domiciliar , Visita Domiciliar , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Saúde Reprodutiva , Fatores de Tempo , Resultado do Tratamento , Saúde da Mulher , Adulto JovemRESUMO
CONTEXT: Catholic Church directives restrict family planning service provision at Catholic health care institutions. It is unclear whether obstetrics and gynecology clinics that are owned by or have business affiliations with Catholic hospitals offer family planning appointments. METHODS: Mystery callers phoned 144 clinics nationwide that were found on Catholic hospital websites between December 2014 and February 2016, and requested appointments for birth control generally, copper IUD services specifically, tubal ligation and abortion. Chi-square and Fisher's exact tests assessed potential correlates of appointment availability, and multivariable logistic regressions were computed if bivariate testing suggested multiple correlates. RESULTS: Although 95% of clinics would schedule birth control appointments, smaller proportions would schedule appointments for copper IUDs (68%) or tubal ligation (58%); only 2% would schedule an abortion. Smaller proportions of Catholic-owned than of Catholic-affiliated clinics would schedule appointments for birth control (84% vs. 100%), copper IUDs (4% vs. 97%) and tubal ligation (29% vs. 72%); for birth control and copper IUD services, no other clinic characteristics were related to appointment availability. Multivariable analysis confirmed that tubal ligation appointments were less likely to be offered at Catholic-owned than at Catholic-affiliated clinics (odds ratio. 0.1); location and association with one of the top 10 Catholic health care systems also were significant. CONCLUSIONS: Adherence to church directives is inconsistent at Catholic-associated clinics. Women visiting such clinics who want highly effective methods may need to rely on less effective methods or delay method uptake while seeking services elsewhere.
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Catolicismo , Anticoncepção/estatística & dados numéricos , Serviços de Planejamento Familiar/estatística & dados numéricos , Hospitais Religiosos/organização & administração , Religião e Medicina , Aborto Induzido/estatística & dados numéricos , Feminino , Humanos , Dispositivos Intrauterinos de Cobre/estatística & dados numéricos , Gravidez , Estados UnidosRESUMO
OBJECTIVE: Sexual dysfunction can be a long-term issue for women with gynecologic cancer. This study assesses the extent of sexual and marital dysfunction women face following treatment of a gynecologic cancer. METHODS: A cross-sectional study of women with gynecologic cancer was conducted using a 181-item survey. Sexual dysfunction was measured by change in the Female Sexual Function Index score; marital dysfunction was measured by change in Intimate Bond Measure from prediagnosis to posttreatment. Paired t tests and Fisher exact test were used to compare women with dysfunction to those without dysfunction. RESULTS: Three hundred twenty women were enrolled (mean age, 56.0 [SD, 12.0] years). Among all women, sexual function declined from a score of 21.3 (SD, 10.4) prior to 15.3 (SD, 10.2) (P < 0.001), and sexual activity decreased from 6.1 (SD, 6.8) to 2.6 (SD, 4.9) times per month following treatment (P < 0.001). Among the 208 women who were sexually active at the time of study, sexual dysfunction after treatment was associated with younger age (50.9 [SD, 11.7] years to 57.3 [SD, 12.3] years), ovarian (40.7% vs 30.7%) or cervical (21.0% vs 10.2%) cancer diagnosis, chemotherapy treatment (72.8% vs 50.4%), and being in a relationship (97.3% vs 82.7%). Among women in relationships, 27% experienced marital dysfunction. CONCLUSIONS: Women who are younger, have an ovarian or cervical cancer diagnosis, receive chemotherapy, or are in a committed relationship are at particularly high risk of sexual dysfunction. These women should be provided information about the risks associated with their cancer treatment.
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Relações Interpessoais , Neoplasias Ovarianas/fisiopatologia , Neoplasias Ovarianas/psicologia , Disfunções Sexuais Fisiológicas/etiologia , Disfunções Sexuais Psicogênicas/etiologia , Neoplasias do Colo do Útero/fisiopatologia , Neoplasias do Colo do Útero/psicologia , Estudos Transversais , Feminino , Humanos , Casamento , Pessoa de Meia-Idade , Neoplasias Ovarianas/tratamento farmacológico , Disfunções Sexuais Fisiológicas/psicologia , Disfunções Sexuais Psicogênicas/psicologia , Neoplasias do Colo do Útero/tratamento farmacológicoRESUMO
OBJECTIVE: Preoperative histology is a major component in the perioperative selective lymph node (LN) dissection decision process. Discrepancy between preoperative endometrial sampling and final specimen histopathology is generally accepted. The goals of this project are to determine if discrepancy of histopathology is associated with alteration of adjuvant treatment or outcome. MATERIALS AND METHODS: We performed a retrospective cross-sectional analysis of all patients undergoing surgery for endometrial cancer at a single institution from 2010 to 2014. All patients had preoperative endometrial sampling. Histopathology discrepancy was evaluated for potential in variation of perioperative LN dissection. Criteria for not performing LN dissection was defined as preoperative endometrioid histology, grade 1 or 2 lesion, myometrial invasion of 50% or less, and primary tumor diameter 2 cm or less. RESULTS: A total of 352 patients were identified; 44 were excluded because of no preoperative pathology or no residual disease on final pathology. Discrepancy of histopathology was noted in 64/308 (20.8%; 95% confidence interval [CI], 16.2%-25.3%) patients. Preoperative endometrioid histology was noted in 272 patients, and 17/272 (6.3%; 95% CI, 3.4%-9.1%) had preoperative sampling reviewed as a grade 1 or 2 endometrioid lesion and final specimen was upgraded to grade 3. Downstaging occurred in 3/272 (1.1%; 95% CI, 0%-2.3%) patients with preoperative grade 3 lesion and final specimen demonstrated grade 1 or 2 disease. All 3 patients' primary tumor diameter was greater than 2 cm and therefore received LN dissection. Histopathological discrepancy that would alter perioperative LN dissection decision based on the aforementioned criteria occurred in 2/272 (0.7%; 95% CI, 0%-1.8%). CONCLUSIONS: Despite a 20% discrepancy of preoperative and postoperative histopathology, discrepancy that would alter a perioperative decision for LN dissection occurs in only 0.7% of cases in this retrospective single-institutional experience. Myometrial invasion and tumor size may be more influential than histology in LN selection criteria.
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Carcinoma Endometrioide/patologia , Carcinoma Endometrioide/cirurgia , Neoplasias do Endométrio/patologia , Neoplasias do Endométrio/cirurgia , Linfonodos/cirurgia , Estudos Transversais , Feminino , Humanos , Excisão de Linfonodo/métodos , Linfonodos/patologia , Invasividade Neoplásica , Cuidados Pré-Operatórios/métodos , Estudos RetrospectivosRESUMO
OBJECTIVE: Current national guidelines recommend preoperative thoracic imaging for all patients undergoing surgery for endometrial cancer. The objective of this project was to report the incidence of pulmonary metastasis in endometrial cancer patients and describe tumor and patient characteristics to better identify a low-risk population for thoracic involvement. We evaluated the ideal modality of preoperative imaging for both low-risk and high-risk populations based on the risk of pulmonary involvement. METHODS: A retrospective cross-sectional study of patients undergoing surgical evaluation for endometrial cancer at a single institution from 2010 to 2014 was performed. Low-risk patients were defined as having a preoperative pathology sample showing grade 1 or 2 endometrioid endometrial cancer and a physical examination not concerning for extrauterine disease spread. RESULTS: A total of 352 patients were evaluated, of which 327 (92.9%) had preoperative thoracic imaging. Twenty-six patients had benign pathology or no preoperative sampling, leaving 301 patients for analysis. There were 228 (75.7%) of 301 patients classified as low-risk by our criteria. There were 20 (8.8%) of 228 low-risk patients with initial imaging concerning for pulmonary metastasis, but follow-up showed no evidence of disease. No low-risk patients (0/228; 95% confidence interval [CI], 0%-0.02%) had pulmonary metastasis. There were 4 (1.3%) of 301 (95% CI, 0%-0.04%) patients diagnosed with pulmonary metastasis based on preoperative imaging, and 4 (1.3%) of 301 (95% CI, 0.01%-0.04%) patients with recurrent pulmonary disease. Median time to pulmonary recurrence was 20 months. CONCLUSIONS: The incidence of pulmonary metastasis found on preoperative imaging is exceptionally low in our defined low-risk population. All of the patients with pulmonary involvement either initially or upon recurrence had high-risk features. Given our findings, we would recommend that providers consider chest x-ray as the appropriate screening modality for the low-risk population and chest computed tomography for the high-risk population.
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Neoplasias do Endométrio , Neoplasias Pulmonares/secundário , Radiografia Torácica , Idoso , Estudos Transversais , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Estudos RetrospectivosRESUMO
OBJECTIVE: The aim of this study was to compare perimenopausal symptomatology using a levonorgestrel-containing intrauterine system (LNG-IUS) + low-dose transdermal estradiol (TDE) with LNG-IUS alone. METHODS: The trial was a double-blind, randomized, controlled pilot trial. Regularly cycling women aged 38 to 52 years, with at least one self-reported symptom (hot flashes, bloating, headache, adverse mood, or poor sleep), were randomized to either LNG-IUS + low-dose TDE gel (intervention) or LNG-IUS alone (control). TDE was administered once daily as a 0.06% gel containing 0.75âmg of TDE for 50 days. LNG-IUS was placed at least 90 days before TDE or placebo gel treatment to assure stable circulating LNG. Participants completed the Center for Epidemiologic Studies Depression scale (CESD), Hot Flash Related Daily Interference scale (HFRDIS), Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS) at the time of LNG-IUS placement, at 90 days (the time of randomization to TDE/placebo), and 140 days (end of study). TDE and placebo groups were compared using repeated-measures analysis of variance. RESULTS: Thirty-eight women aged 42.9â±â2.7 years, with a mean BMI of 24.7â±â3.3âkg/m², were enrolled; 20 were randomized to TDE. Women receiving TDE had significantly improved FSS scores between days 90 and 140 (mean difference TDE: -0.8â±â1.2 vs placebo: 0.1â±â0.7; Pâ=â0.026) and borderline significant improvement in HFRDIS scores (mean difference TDE: -5.5â±â15.3 vs placebo: 4.2â±â13.1; Pâ=â0.076). Women who reported hot flashes at baseline and who received TDE had a significant decrease in HFRDIS scores between days 90 and 140 (nâ=â9, Pâ=â0.035). CESD and PSQI scores were not associated with TDE use. CONCLUSIONS: A brief, low-dose estrogen intervention, combined with a LNG-IUS, led to significant improvement of some common perimenopausal symptoms. Such a "minimalist" approach to management of the perimenopause holds promise for reducing common, bothersome perimenopausal symptoms while maintaining effective contraception.
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Estradiol/administração & dosagem , Levanogestrel/administração & dosagem , Perimenopausa/fisiologia , Útero/efeitos dos fármacos , Administração Cutânea , Adulto , Depressão/tratamento farmacológico , Método Duplo-Cego , Fadiga/tratamento farmacológico , Feminino , Fogachos/tratamento farmacológico , Humanos , Dispositivos Intrauterinos Medicados , Pessoa de Meia-Idade , Projetos Piloto , Placebos , Sono/efeitos dos fármacosRESUMO
BACKGROUND: School-based health centers (SBHCs) may be an ideal setting to address obesity in adolescents because they provide increased access to a traditionally difficult-to-reach population. The study evaluated the feasibility of adding a health educator (HE) to SBHC teams to provide support and increase the delivery of preventive services for overweight or obese adolescents. METHODS: Adolescents with BMI ≥85% recruited from two SBHCs were randomized to a control group (CG) or an intervention group (IG). Both groups received preventive services, including physical examinations and laboratory screening in the SBHC. The educator met with the IG during the academic year, utilizing motivational interviewing techniques to set lifestyle goals. Text messaging was used to reinforce goals between visits. RESULTS: Eighty-two students (15.7±1.5 years of age; BMI, 31.9±6.2 kg/m(2)) were enrolled in the IG and 83 in the control group (16.0±1.5 years of age; BMI, 31.6±6.5 kg/m(2)). Retention was 94% in the IG and 87% in the CG. A total of 54.5% of the IG and 72.2% of the CG decreased or maintained BMI z-score (less than 0.05 increase; p=0.025). Sports participation was higher in the CG (47% vs. 28% in the IG; p=0.02). Mean BMI z-score change was -0.05±0.2 for students participating in sports vs. 0.01±0.2 for those not (p=0.09). CONCLUSIONS: This SBHC intervention showed successful recruitment and retention of participants and delivery of preventive services in both groups. Meeting with an HE did not improve BMI outcomes in the IG. Confounding factors, including sports participation and SBHC utilization, likely contributed to BMI outcomes.
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Comportamento do Adolescente/psicologia , Serviços de Saúde do Adolescente , Entrevista Motivacional , Obesidade/psicologia , Comportamento de Redução do Risco , Serviços de Saúde Escolar , Adolescente , Fenômenos Fisiológicos da Nutrição do Adolescente , Índice de Massa Corporal , Dieta , Exercício Físico , Estudos de Viabilidade , Feminino , Humanos , Masculino , Obesidade/prevenção & controle , Estudantes , Envio de Mensagens de Texto , Resultado do TratamentoRESUMO
OBJECTIVE: This study aims to examine the prognostic importance of preoperative cervical cytologic diagnosis with atypical glandular cells (AGC) or malignant cells (MC) as a predictor of poor outcomes in endometrial cancer. MATERIALS AND METHODS: A total of 563 patients were surgically staged for endometrial adenocarcinoma from 2002 to 2012 at our institution. Of these patients, 106 were included to perform a case-control study (39 patients with AGC or MC and 67 controls). Included patients were not significantly different from excluded patients and were matched for age, race, and body mass index. Outcome variables included presence of extrauterine disease (International Federation of Gynecology and Obstetrics stage ≥II) and high intermediate risk (HIR) disease. Further analysis sought to improve the prediction combining AGC or MC with other factors, such as grade and CA-125 levels. Standard statistical analyses were used. RESULTS: Among the patients with AGC or MC, 53.8% had HIR disease compared with 30.3% with normal cervical cytologic diagnosis (odds ratio [OR], 2.68; 95% confidence interval [CI], 1.18-6.09; P = 0.02). Extrauterine disease was found in 43.6% of patients with AGC or MC compared with that of 15.2% in patients with normal cervical cytologic diagnosis (OR, 4.33; 95% CI, 1.72-10.90; P < 0.01). Multivariate analysis confirmed that AGC or MC was an independent predictor of HIR disease (OR, 8.41; 95% CI, 1.34-52.78; P = 0.02) and extrauterine disease (OR, 4.78; 95% CI, 1.26-18.1; P = 0.02). The combination of elevated CA-125 levels with AGC or MC cervical cytologic diagnosis increased the statistical prediction of extrauterine disease (OR, 13.3; 95% CI, 3.1-56.8; P < 0.01) and HIR disease (OR, 5.83; 95% CI, 1.44-23.71; P = 0.02). CONCLUSIONS: Patients with AGC or MC on preoperative cervical cytology are at risk for extrauterine and HIR disease. These preoperative findings should warn surgeons of the potential of extrauterine or occult metastatic disease.
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Adenocarcinoma/patologia , Neoplasias do Endométrio/patologia , Endométrio/patologia , Idoso , Estudos de Casos e Controles , Feminino , Humanos , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de SaúdeRESUMO
OBJECTIVE: To evaluate whether metformin, when added to a program of personal goal setting, improves weight loss and clinical status in obese adolescents. STUDY DESIGN: In a randomized double-blind placebo controlled trial, 85 adolescents with insulin resistance were randomized to receive metformin (70%) or placebo (30%), along with monthly goal setting for diet and exercise modification. Anthropometric measures, fasting blood analysis, and glucose tolerance tests were performed at baseline and 6 months. RESULTS: Mean age was 15.7 years. Mean body mass index (BMI) was 39.7 kg/m(2). 71% were female, 58% were Hispanic, and 34% were African-American. 76% of participants completed the study. Goal setting alone did not result in significant weight loss. In addition, there were no group differences between metformin and placebo in weight loss or measures of glucose metabolism. However, among females taking metformin, there was a significant decrease in BMI not seen in the placebo group. Furthermore, metformin adherence, when accompanied by lifestyle change, was a predictor of BMI decrease of 5% or more. 60% of 10 subjects who adhered to metformin and decreased portion size decreased BMI by >5%. CONCLUSIONS: In this group of predominately minority adolescents, monthly goal setting alone did not lead to weight loss. Although the addition of metformin had no effect on weight loss overall, the agent did significantly increase weight loss among females and weight loss was predicted by degree of metformin adherence. However, weight loss was only found in those participants also reporting lifestyle change, particularly a decrease in portion sizes. These results suggest that metformin may be a useful agent to promote short-term weight loss among girls making modest lifestyle changes.