Ethical considerations in elective cesarean delivery.
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Cesarean Section↗
Biomedical subjects
Howard Minkoff
Publications and source records attributed to Howard Minkoff.
Ethical dimensions of elective primary cesarean delivery.
Cesarean deliveries are among the most common surgical procedures performed in the United States. Recent publications demonstrate the reduced risks of these operations and describe their potential benefits to both mothers and children. Recent surveys show that a substantial minority of obstetricians would accede to patients' requests for elective primary cesarean delivery, and some of these professionals would prefer that mode of delivery for themselves or their partners. However, scant attention has been paid to the ethical underpinnings of surgery by choice in these circumstances or ethically justified criteria for determining the role of patient choice in elective surgery generally. We define and elaborate upon the role of beneficence-, autonomy-, and justice-based considerations in these deliberations. We conclude that beneficence-based clinical judgment still favors vaginal delivery. Additionally, we have no confidence that either offering or performing elective cesarean delivery is consistent with substantive-justice-based considerations and conclude that there is no autonomy-based obligation to offer cesarean delivery in an ethically and legally appropriate informed consent process. Physicians should respond to patient-initiated requests for such procedures with a thorough informed consent process and request that the woman reconsider to ensure that her autonomy is being meaningfully exercised. In such cases, implementing a woman's request is ethically permissible.
Cesarean Section↗
Natural history of grade 1 cervical intraepithelial neoplasia in women with human immunodeficiency virus.
OBJECTIVE: We sought to estimate rates of progression and regression of grade 1 cervical intraepithelial neoplasia (CIN 1) among women with human immunodeficiency virus (HIV). METHODS: In a multicenter prospective cohort study, HIV-seropositive and HIV-seronegative women were evaluated colposcopically after receiving an abnormal cytology test result between November 1994 and September 2002. Women with CIN 1 were included, except those who had undergone hysterectomy, cervical therapy, or had CIN 2-3 or cervical cancer. Those women who were included were followed cytologically twice yearly, with colposcopy repeated for atypia or worse. RESULTS: We followed 223 women with CIN 1 (202 HIV seropositive and 21 HIV seronegative) for a mean of 3.3 person-years. Progression occurred in 8 HIV-seropositive women (incidence density, 1.2/100 person-years; 95% confidence interval [CI] 0.5-2.4/100 person-years) and in no HIV seronegative women. Regression occurred in 66 (33%) HIV-seropositive women (13/100 person-years, 95% CI 10-16/100 person-years) versus 14 (67%) seronegative women (32/100 person-years, relative risk 0.40, 95% CI 0.25-0.66; P < .001). In multivariate analysis, regression was associated with human papillomavirus (HPV) detection (hazard ratio [HR] for low risk 0.28, 95% CI 0.13-0.61, P = .001; and for high-risk 0.34, 95% CI 0.20-0.55, P < .001 versus no HPV detected) and Hispanic ethnicity (HR 0.48, 95% CI 0.230.98; P = .04); HIV serostatus was only marginally linked to regression (HR 0.52, 95% CI 0.27-1.03; P = .06), but seropositive women were less likely to regress when analysis was limited to 146 women with HPV detected at CIN 1 diagnosis (HR 0.18, 95% CI 0.05-0.62; P = .006). CONCLUSION: Grade 1 cervical intraepithelial neoplasia infrequently progresses in women with HIV. Thus, observation appears safe absent other indications for treatment. LEVEL OF EVIDENCE: II-1.
Adult↗
Melissa Rowland and the rights of pregnant women.
On March 11, 2004, the State of Utah charged Melissa Rowland with the murder of her stillborn fetus, claiming that the death resulted from her rejection of the advice of her physicians to have a cesarean delivery. Although Ms. Rowland avoided the homicide charge by pleading guilty to lesser child endangerment charges, the approach taken by the State raises important and troubling issues regarding the autonomy rights of pregnant women, as well as their right to speak on behalf their unborn children. We use this case to review relevant ethical principals and legal precedents. We conclude that if Ms. Rowland is to be judged legally culpable for the death of her fetus, then the courts must first create a new and significant exception to the doctrine of informed consent and the common law and constitutional principles upon which it is based. Such a precedent could introduce a substantial disparity between the rights of pregnant women and those of all other persons. We would argue that a better means of assuring the health interests of the pregnant woman and the fetus in similar circumstances is through advocacy by obstetricians for pregnant women's fully realized rights, including the right to informed consent.
Adult↗
Changes in sexual behavior among HIV-infected women after initiation of HAART.
OBJECTIVES: We assessed the association between initiation of highly active antiretroviral treatment (HAART) regimens and sexual risk behaviors among HIVinfected women. METHODS: We analyzed data from 724 women who initiated HAART between January 1996 and January 2001 and who had pre-HAART viral loads at or above 400 copies per milliliter. RESULTS: Sexually active women were less likely (odds ratio [OR] = 0.79) to report 2 or more partners during a 6-month period after HAART initiation than before HAART initiation. However, the risk for unprotected sex was higher after HAART initiation than before HAART initiation among all sexually active women (both those who reported 2 or more partners [OR = 1.84] and those who reported 1 partner [OR = 1.22]). CONCLUSIONS: Sexual risk behaviors are associated with receipt of therapy but not with therapeutic response, indicating a risk for transmission among female HAART recipients.
Adult↗
Serum immunoglobulin A response to human papillomavirus type 16 virus-like particles in human immunodeficiency virus (HIV)-positive and high-risk HIV-negative women.
Serum samples from 2008 human immunodeficiency virus (HIV)-positive and 551 HIV-negative women were tested for immunoglobulin A (IgA) to human papillomavirus (HPV) type 16 capsids. IgA seropositivity was lower than previously reported IgG seropositivity (7% vs. 51%), but, like IgG antibodies, HPV 16 IgA was associated with sexual behavior, cervicovaginal HPV 16 DNA, and cytological abnormalities. IgA seropositivity was higher in HIV-positive women than in HIV-negative women (7.7% vs. 4.9%; P=.02), but the association was lost after adjustment for HPV 16 cervicovaginal infection. IgA, but not IgG, seropositivity was associated with progression to high-grade cytological abnormalities (relative hazard [RH], 2.2 [95% confidence interval, 1.2-4.2]), raising the possibility that an IgA response to HPV 16, as described for other DNA viruses, may be a marker of persistent viral replication. The risk of incident infection with non-16-related HPV types was increased in IgA seropositive women (RH, 1.8 [95% confidence interval, 1.3-2.6]), compared with seronegative women (RH, 2.2 [95% confidence interval, 0.9-5.4]), but there was no difference in the risk of incident HPV 16 or HPV 16-related infections. This may be evidence of partial type-specific or clade-specific immunity conferred by seropositivity to HPV 16 capsids.
Antibodies, Viral↗
HIV-1 in genital tract and plasma of women: compartmentalization of viral sequences, coreceptor usage, and glycosylation.
Worldwide, 90% of HIV-1 infections are transmitted heterosexually. Because the genital mucosa are the sites of initial contact with HIV-1 for most exposed individuals, study of the virus from the genital tract is critical for the development of vaccines and therapeutics. Previous analyses of HIV-1 in various tissues have documented compartmentalization of viral genomes. Whether compartmentalization was associated with viral phenotypic differences or immune status, however, was not well understood. We compared HIV-1 gp120 env sequences from the genital tract and plasma of 12 women. Eight women displayed compartmentalized HIV-1 RNA genomes, with viral sequences from each site that were clearly discrete, yet phylogenetically related. The remaining four exhibited env sequences that were intermingled between the two sites. Women with compartmentalized HIV-1 genomes had higher CD4+ cell counts than those displaying intermingled strains (P = 0.02). Intrapatient HIV-1 recombinants comprising sequences that were characteristic of both sites were identified. We next compared viral phenotypes in each compartment. HIV-1 coreceptor usage was often compartmentalized (P 0.01). The number of N-linked glycosylation sites, associated with neutralization resistance, also differed between compartments (P < 0.01). Furthermore, disparities between the density of gp120 glycosylations in each compartment correlated with higher CD4+ counts (P = 0.03). These data demonstrate that the genital tract and plasma can harbor populations of replicating HIV-1 with different phenotypes. The association of higher CD4+ cell counts with compartmentalization of viral genomes and density of gp120 glycosylations suggests that the immune response influences the development of viral genotypes in each compartment. These findings are relevant to the prevention and control of HIV-1 infection.
Adult↗
Human papillomavirus type 16 and immune status in human immunodeficiency virus-seropositive women.
BACKGROUND: Human papillomavirus (HPV) type 16 is etiologically associated with approximately half of all cervical cancers. It is important, therefore, to determine the characteristics that distinguish HPV16 from other HPV types. A preliminary result based on cross-sectional baseline data in the Women's Interagency Human Immunodeficiency Virus (HIV) Study (WIHS) suggested that the prevalence of HPV16 might have a weaker association with immune status in HIV-seropositive women than that of other HPV types. To address this issue, we examined HPV test results from repeated study visits in the WIHS and from an independent study, the HIV Epidemiology Research Study (HERS). METHODS: HIV-seropositive women in the WIHS (n = 2058) and in the HERS (n = 871) were assessed semiannually. HPV DNA was detected in cervicovaginal lavage specimens by using polymerase chain reaction assays. Prevalence ratios were used to compare the prevalence of each HPV type in women with the lowest CD4+ T-cell counts (<200 T cells/mm3) with that of women with the highest CD4+ T-cell counts (> or =500 T cells/mm3). A summary prevalence ratio for each HPV type (i.e., across visits and studies) was estimated using generalized estimating equations. The association of CD4+ T-cell stratum with type-specific HPV incidence was measured using multivariable Cox regression models. All statistical tests were two-sided. RESULTS: The prevalence ratio for HPV16 was low compared with that of other HPV types at every study visit in both cohorts. The generalized estimating equation summary prevalence ratio for HPV16 (1.25, 95% confidence interval [CI] = 0.97 to 1.62) was the smallest measured, and it was statistically significantly lower than that of all other HPV types combined (P =.01). The association of CD4+ T-cell stratum with HPV16 incidence was also among the smallest measured (hazard ratio = 1.69, 95% CI = 1.01 to 2.81). CONCLUSIONS: The prevalent and incident detection of HPV16 is more weakly associated with immune status in HIV-seropositive women than that of other HPV types, suggesting that HPV16 may be better at avoiding the effects of immune surveillance, which could contribute to HPV16's strong association with cervical cancer.
AIDS-Related Opportunistic Infections↗
Elective primary cesarean delivery.
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Cesarean Section↗
Protease inhibitor use and the incidence of diabetes mellitus in a large cohort of HIV-infected women.
OBJECTIVE: To assess the association between protease inhibitor (PI) use and the incidence of diabetes mellitus (DM) among participants in the Women's Interagency HIV Study. DESIGN: Prospective multicenter cohort study. The diagnosis of DM was based on self-report at semiannual interviews conducted from 1994 to 1998. SETTING: Six inner-city clinical sites in the United States (Brooklyn, NY; Bronx, NY; Washington, DC; Chicago, IL; San Francisco, CA; and Los Angeles, CA). PARTICIPANTS: A total of 1785 nonpregnant women who had no history of prior DM. The women made up four groups: 1) PI users (n = 609, person-years [PY] at risk = 707); 2) reverse transcriptase inhibitor (RTI)-only users (n = 932, PY = 1486); 3) HIV-infected women reporting no antiretroviral therapy (ART) ever (n = 816, PY = 1480); and 4) HIV-uninfected women (n = 350, PY = 905). MAIN OUTCOMES: Incidence of DM and median body mass index (BMI) from 1995 to 1998 were compared among the four groups. RESULTS: Sixty-nine incident cases of DM occurred among 1785 women (1.5 cases per 100 PY; 95% CI: 1.2-1.9). The incidence of DM among PI users was 2.8 cases per 100 PY (2.8%) versus 1.2% among both RTI users and women on no ART (95% CI: 1.6-4.1 [PI]; 0.7-1.8 [RTI and no ART]; P = 0.01 for comparison of the PI group with the RTI group) and 1.4% among HIV-uninfected women (95% CI: 0.7-2.2, P = 0.06 for comparison with PI group). Weight gain was not associated with either PI or RTI use. Multivariate models identified PI use (hazard ratio [HR] = 2.90 [95% CI: 1.50-5.60]; P = 0.002), age (HR = 1.75 per 10 years [95% CI: 1.31-2.34]; P = 0.0002) and BMI as independent risk factors for DM. CONCLUSIONS: PI use was associated with a threefold increase in the risk of reporting incident DM. Routine screening for diabetes, particularly among older and heavier patients using PI therapy, is advisable.
Adult↗
Risk factors for Kaposi's sarcoma-associated herpesvirus infection among HIV-1-infected pregnant women in the USA.
OBJECTIVES: We sought to identify risk factors for infection with the Kaposi's Sarcoma-associated herpesvirus (KSHV) among pregnant women and to examine a reported association of KSHV with injecting drug use (IDU) and hepatitis C virus (HCV) infection. DESIGN: Cross-sectional evaluation of questionnaire data and KSHV and HCV seroprevalence in the Women and Infants Transmission Study. METHODS: In sera collected from HIV-1-infected pregnant women (n = 887) and, at age 12 months, their offspring (n = 900) at six sites in the USA and Puerto Rico, KSHV and HCV antibodies were detected with sensitive and specific enzyme immunoassays. Risk of KSHV was estimated by the unadjusted and adjusted odds ratio (OR(adj)) and 95% confidence interval (CI). The geographic referent sites were Chicago and Boston. RESULTS: Forty-seven (5.3%) of the women and three (0.3%) of the infants were KSHV seropositive. In univariate and multivariate analyses, KSHV in the women was associated with enrollment in Puerto Rico, Houston or Brooklyn (OR(adj), 4.3; 95% CI, 1.8-10.4) or Manhattan (OR(adj), 9.8; 95% CI, 3.7-25.6); non-completion of high school (OR(adj), 1.8; 95% CI, 0.9-3.4); the number of sexually transmitted diseases (OR(adj), 1.4; 95% CI, 1.0-1.9 per disease); and especially with IDU and HCV infection (OR(adj), 3.5; 95% CI, 1.5-7.9). CONCLUSIONS: Transmission of KSHV by blood inoculation may be highly inefficient, but our data support the hypothesis that it does occur. Large formal studies to evaluate whether KSHV transmission occurs via transfusion are needed to inform decisions regarding screening volunteer blood donors to protect the blood supply.
AIDS-Related Opportunistic Infections↗
C-reactive protein is an independent predictor of mortality in women with HIV-1 infection.
The relationship of C-reactive protein (CRP) to mortality was assessed in 209 HIV-1-infected women after adjusting for age, body mass index (BMI), serum albumin, CD4 cell lymphocyte count, and HIV-1 RNA. During the follow-up period of up to 5 years (median = 45 months) there were 49 deaths. CRP at study enrollment was measured using a low sensitivity assay. CRP levels were only weakly correlated (Pearson correlation coefficient r < .2) with other predictors of mortality. CRP was a powerful predictor of mortality (p < .01) after adjusting for age, BMI, serum albumin, CD4 cell lymphocytes, and HIV-1 RNA. The relative hazard associated with an elevated CRP level, independent of the covariates noted above, varied from 3.4- to 13.6-fold depending on how CRP values were grouped. CRP may be a useful and inexpensive predictor of HIV disease mortality in women.
Adult↗
CC chemokine receptor 5 genotype and susceptibility to transmission of human immunodeficiency virus type 1 in women.
The human gene for CC chemokine receptor 5, a coreceptor for human immunodeficiency virus type 1 (HIV-1), affects susceptibility to infection. Most studies of predominantly male cohorts found that individuals carrying a homozygous deleted form of the gene, Delta 32, were protected against transmission, but protection did not extend to Delta 32 heterozygotes. The role played by this mutation in HIV-1 transmission to women was studied in 2605 participants in the Women's Interagency HIV Study. The Delta 32 gene frequency was 0.026 for HIV-1-seropositive women and 0.040 for HIV-1-seronegative women, and statistical analyses showed that Delta 32 heterozygotes were significantly less likely to be infected (odds ratio, 0.63 [95% confidence interval, 0.44-0.90]). The CCR5 Delta 32 heterozygous genotype may confer partial protection against HIV-1 infection in women. Because Delta 32 is rare in Africans and Asians, it seems plausible that differential genetic susceptibility, in addition to social and behavioral factors, may contribute to the rapid heterosexual spread of HIV-1 in Africa and Asia.
Cohort Studies↗
Serum immunoglobulin G response to human papillomavirus type 16 virus-like particles in human immunodeficiency virus (HIV)-positive and risk-matched HIV-negative women.
Baseline serum samples from 2815 human immunodeficiency virus (HIV)-positive and 963 HIV-negative women enrolled in 2 cohort studies were tested for immunoglobulin G antibodies to human papillomavirus type 16 (HPV-16) capsids. HPV-16 seropositivity was associated with lifetime number of sex partners (P<.001) among both HIV-positive and HIV-negative women. Approximately 50%-60% of HPV-16 DNA-positive women were HPV-16 positive. HPV-16 seropositivity was associated with HIV infection; however, after adjustment for baseline cervical HPV infection and disease, the association disappeared. Thus, the high seroprevalence of HPV-16 among HIV-positive women may be explained by a high prevalence of HPV of all types. Approximately 50% of HIV-positive women had serological evidence of prior HPV-16 infection, but only approximately 5% had an HPV-16 cervical infection at baseline. Despite the higher prevalence of HPV infection in this group, most HIV-positive women are able to control HPV-16 replication at the cervix, and reactivation, if it occurs, is not very common.
AIDS-Related Opportunistic Infections↗
Human immunodeficiency virus infection in pregnancy.
The transformation of the human immunodeficiency virus (HIV) epidemic over the last 20 years has been remarkable. With access to appropriate therapies, clinicians can now offer infected women a much improved prognosis as well as a very high likelihood of birthing children who will be HIV uninfected. However, these advances are purchased through the use of complicated, expensive medical regimens (highly active antiretroviral therapy) that are associated with a litany of toxicities and risks. In caring for HIV-infected pregnant women and prescribing these medications, obstetricians must always bear in mind their dual responsibilities, providing optimal care to the mother and reducing the likelihood of mother-to-child transmission of HIV. To accomplish those goals, the physician must first monitor the patient's immunological and virological status including resistance testing. The results of those tests will guide the clinician in choosing when to initiate therapy and in deciding whether to use regimens directed solely at transmission interruption or those that will simultaneously treat the mother's infection. When using highly active antiretroviral therapy, physicians must be cognizant of the pregnancy-specific risks associated with some of the component agents. The core goal of all medical therapy is to bring the patient's viral load to an undetectable level. When that goal is reached, the chance of transmission to the child is minimized, the need for a cesarean delivery is reduced, and the patient's prognosis is optimized. However, if a woman is not pregnant, then the initiation of therapy can be delayed because long-term adherence with medications can be difficult, side effects are not uncommon, and prognosis is not adversely affected so long as the CD4 count and the viral load remain in a reasonable range. None of the advantages cited above can be achieved unless all women have their HIV status determined as early in pregnancy as possible.
Antiretroviral Therapy, Highly Active↗
Substance use and psychotherapeutic medications: a likely contributor to menstrual disorders in women who are seropositive for human immunodeficiency virus.
OBJECTIVE: The purpose of this study was to evaluate the impact of substance use and psychotherapeutic medications on menstrual characteristics in women who are human immunodeficiency virus seropositive and seronegative. STUDY DESIGN: Menstrual calendars were prospectively collected for 1075 women who were human immunodeficiency virus seropositive and seronegative and who were enrolled in the Women's Interagency Human Immunodeficiency Virus Study or the Human Immunodeficiency Virus Epidemiology Research Study; several of the women were substance users or recipients of psychotherapeutic medications. RESULTS: Women who received methadone maintenance and who used injection drugs had substantially increased odds of a cycle of >or=90 days (odds ratio, 2.28; 95% CI, 1.23-4.22; and odds ratio, 3.87; 95% CI, 2.16-6.95, respectively). The use of psychotherapeutic medications increased the odds of having very short cycles, <18 days, and cycles of >or=90 days (odds ratio, 1.69; 95% CI, 1.16-2.45; and odds ratio, 1.86; 95% CI, 1.03-3.36, respectively). CONCLUSION: Clinicians should evaluate substance use, participation in methadone maintenance programs, and the use of psychotherapeutic medications and consider the neuroendocrinologic effects of these medications as a potential cause of menstrual disruptions.
Adult↗
The role of covering gowns in reducing rates of bacterial contamination of scrub suits.
OBJECTIVE: This study was undertaken to determine whether covering gowns reduce the rates of contamination of surgical scrubs. STUDY DESIGN: Seventy-five clinicians had pieces of fabric from clean scrubs attached to two areas of their scrub suits. Participants wore a covering garment when wearing scrub suits off of designated areas (n = 25), did not wear a covering garment (n = 25), or wore scrub suits outside the hospital (n = 25). Subsequently, the fabric was assessed with culture in enhanced broth media and blood agar. RESULTS: Although there was a trend toward lower rates of contamination in the group that did not wear a covering garment, the difference was not significant. At no point, and at neither site of fabric attachment, did those who wore a covering garment demonstrate any advantage in regard to levels or frequency of contamination. CONCLUSION: Wearing covering garments over scrub suits does not reduce rates of contamination.
Bacteria↗
The relationship of pregnancy to human immunodeficiency virus disease progression.
OBJECTIVE: This study was undertaken to determine the effect of pregnancy on progression of human immunodeficiency virus (HIV) disease. STUDY DESIGN: We compared the immunologic, clinical, and virologic courses of 953 women who had no additional pregnancy after their index pregnancy, with the courses of 329 women who had a second pregnancy subsequent to their index pregnancy. Baseline variables included use of antiretroviral therapy, and CD4 and HIV RNA values. A linear spline growth curve model was used to describe trajectories of variables. The Cox proportional hazards model was used to assess selected covariates on the time to development of clinical class C events or death. RESULTS: Women with repeat pregnancies were less likely to be on antiretroviral therapy at baseline and had a higher CD4% count immediately after their first delivery. The average trajectory of CD4 values in the one-pregnancy group was almost identical to the average trajectory in the repeat pregnancy group. RNA levels in the single-pregnancy group started higher but ended lower than in the second-pregnancy group, although slope differences were modest. There were no significant differences in time to class C events, although women in the repeat-pregnancy group tended to survive longer. CONCLUSION: Repeat pregnancies do not have significant effects on the course of HIV disease.
Acquired Immunodeficiency Syndrome↗