958 resultados para Vaginal smears


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This dissertation examined the impact of acculturation and the influence of the family (specifically parenting practices) on Hispanic youth's sexual behavior and reproductive health and is presented in the form of three papers. In the first paper, we assessed the reliability and validity of the Bicultural Acculturation Scale/Language Proficiency (BAS/LP) subscale for use among Hispanic middle school-aged youth. The purpose of the second paper was to examine the associations between initiation of vaginal intercourse, parental monitoring, and parent-child communication while controlling for acculturation and other recognized covariates. Finally, the purpose of the third dissertation paper was to examine HPV vaccine knowledge, attitudes, and acceptability among Hispanic mothers and girls using strategic focus groups. The three papers will jointly extend the knowledge about Hispanic youth and their parents regarding both sexual initiation and uptake of the HPV vaccine. In addition, findings from the papers can inform the development of interventions for Hispanic youth and their parents to delay sexual initiation and increase HPV vaccine uptake.^

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Background. Previous research shows inconsistent results as to the association between part-time employment and sexual behavior among younger teens. Studies of older teens cannot be generalized to younger teens because of the wide differences in types of work performed, nature of work environments, and work intensity. Objective. Examine the relationship between part-time employment and sexual behavior in a cross-sectional sample of public middle school students in Houston, Texas. Methods . The study presents a secondary analysis of data from the It’s Your Game…Keep it Real baseline data collection (11/2004–1/2005). It’s Your Game… is an intervention program for middle school students designed to prevent Sexually Transmitted Infections. Statistical analysis. Univariate and multivariate logistic regression analyses were conducted to examine the association between part-time employment and vaginal intercourse: (a) ever had sex; and (b) current sexual activity. Results. Overall, 13.2% of students worked for pay; male students were 1.5 times as likely as females to be working. Of all the students, 11.0% had had sexual intercourse; students who worked were 3 times more likely to be sexually experienced than those who did not. Among students who were sexually experienced, 67.0% were currently sexually active. After adjusting for the other covariates, Hispanic students were almost 3.6 times more likely to report current sexual activity compared to students in other racial/ethnic groups. In univariate analysis, students who worked 1-5 hrs/week were more likely to be sexually experienced than those not currently employed, and the likelihood increased with number of hours worked. There is a similar pattern in the multivariate model, but the odds ratios are too close for the evidence to be more than suggestive. Of sexually experienced students, students working 1-5 hrs/week were 2.7 times more likely to report current sexual intercourse than those not working; those working >5 hrs/week were 4.7 times more likely. The multivariate model showed a similar increase in likelihood, and adjustment for covariates increased these associations: students who worked 1-5 hrs/week were 3.6 times more likely to report current sexual intercourse, and students who worked >5 hrs/week were 4.5 times more likely, than students not currently employed.^

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This descriptive, cross-sectional study addressed the relationship between variables of deployed military women and prevalence of gender-specific infections. The analysis of secondary data will look at the last deployment experience of 880 randomly selected U.S. military women who completed a mailed questionnaire (Deployed Female Health Practice Questionnaire (FHPQ)) in June 1998. The questionnaire contained 191 items with 80 data elements and one page for the subject's written comments. The broad categories of the questionnaire included: health practices, health promotion, disease prevention and treatment, reproduction, lifestyle management, military characteristics and demographics. The research questions are: (1) What is the prevalence of sexually transmitted diseases (STD), urinary tract infections (UTI) and vaginal infections (VI) related to demographic data, military characteristics, behavioral risk factors and health practices of military women during their last deployment? and (2) What are the differences between STD, UTI and VI related to the demographic data, military characteristics, behavioral risk factors and health practices of military women during their last deployment. The results showed that (1) STDs were found to be significantly associated with age and rank but not location of deployment or military branch; (2) UTI were found to be significantly associated with intrauterine device (IUD) use, prior UTI and type of items used for menses management, but not education or age; and (3) VI were significantly associated with age, rank and deployment location but not ethnicity or education. Although quantitative research exploring hygiene needs of deployed women continues, qualitative studies may uncover further “hidden” issues of importance. It cannot be said that the military has not made proactive changes for women, however, continued efforts to hone these changes are still encouraged. Mandatory debriefings of “seasoned” deployed women soldiers and their experiences would benefit leadership and newly deployed female soldiers with valuable “lessons learned.” Tailored hygiene education material, prevention education classes, easy access website with self-care algorithms, pre-deployment physicals, revision of military protocols for health care providers related to screening, diagnosing and treatment of gender-specific infections and process changes in military supply network of hygiene items for women are offered as recommendations. ^

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Background. The elderly population aged 60 and above is increasing rapidly throughout the world. The aging process affects physical health of individuals, which in turn affects sexuality and sexual activity. However, many elderly adults continue to engage in one or more forms of sexual activities well into their 70s, 80s, and even in 90s. Despite the widespread stereotypes, misconceptions, and negative attitudes surrounding sexuality in elderly adults, it has been found to be an important aspect of the health of the elderly. However, association between the frequency of sexual activity and mental well being among older adults has not been documented in the literature. ^ Methods. To test the hypotheses that mental well being indicators such as depression, anxiety, and stress were inversely associated with greater frequency of sexual intimacy, a secondary data analysis was conducted using the National Social Life Health and Aging Project (NSHAP) using multivariate logistic regression. The NSHAP was a population-based study that was conducted on a national scale including 1455 men and 1550 women aged 57-85.^ Results. Approximately 1430 (54.1%) of the total population reported being sexually intimate in the past 12 months whereas 1481 (45.9%) participants reported that they did not perform any sexual activity in the past 12 months. In addition, approximately 895(31.1%) participants reported engaging in sexual activity ≥ 2-3 times per month with 665 (78.9%) of these participants reported performing vaginal intercourse only, 14(2.0%) oral sex only, and 89(10.5%) reported performing both vaginal intercourse and oral sex. Controlling for socio-demographic characteristics, frequently (≥2-3 times per month) sexually active participants showed lower odds ratio of depression (OR= 0.60; 95%CI = 0.46, 0.78), anxiety (OR= 0.67; 95% CI= 0.53, 0.86), and stress (OR=0.73; 95% CI = 0.6, 0.88) compared to those who had less frequent sexual activity or who had no sexual activity in the past 12 months.^ Conclusion. Lower levels of depression, anxiety, and stress appear to be associated with greater frequency of sexual activity. Public health interventions should focus on educating elderly adults about their sexual health and how to seek medical help for their sexual problems. Public health professionals should also be educated on how to best assess sexual needs of the elderly adults.^

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Background. Literature worldwide has documented associations between gender-based relationship inequity, sexual communication self-efficacy, and actual use of condoms and contraceptives among young women. However studies that have rigorously tested these associations in southern Vietnam are extremely rare. This study aimed to examine these associations and other current sexual practices among undergraduate female students in the Mekong Delta. Method. A qualitative study was conducted to examine the operationalization of the Theory of Gender and Power and to obtain salient and culture-relevant dimensions of perceived gender relations in the Mekong Delta of Vietnam. Sixty-four undergraduate female students from two universities participated in eight group discussions focusing on their viewpoints regarding national and local gender equity issues. A subsequent cross-sectional survey consisting of 1181 third-year female students from Can Tho University and An Giang University was conducted. Latent variable modeling and logistic regression were employed to examine the hypothesized associations. Results. Dimensions of perceived gender relations were attributable to theoretical structures of labor, power, and cathexis. Perceptions about gender inequities were comparable to findings from several reports, in which women were still viewed as inferior and subordinate to men. Among students who had ever had a boyfriend(s) (72.4%), 44.8% indicated that their boyfriend had ever asked for sex, 13% had ever had penile-vaginal sex, and 10.3% had ever had oral sex. For those who had ever had penile-vaginal sex, 33% did not use any contraceptive method at first sex. The greater a student’s perception that women were subordinate to men, the lower her self-efficacy for sexual communication and the lower her actual frequencies of asking for contraceptive or condom use. Sexual communication self-efficacy was marginally associated with actual contraceptive use (p=.039) and condom use (p=.092) at first sex. Conclusion. Sexual health promotion strategies should address the influence of perceived unequal gender relations on young women’s sexual communication self-efficacy and the subsequent impact on actual contraceptive and condom use.^

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The general research question for this dissertation was: do the data on adolescent sexual experiences and sexual initiation support the explicit or implicit adolescent sexuality theories informing the sexual health interventions currently designed for youth? To respond to this inquiry, three different studies were conducted. The first study included a conceptual and historical analysis of the notion of adolescence introduced by Stanley Hall, the development of an alternative model based on a positive view of adolescent sexuality, and the rationale for introducing to adolescent sexual health prevention programs the new definitions of sexual health and the social determinants of health approach. The second one was a quantitative study aimed at surveying not only adolescents' risky sexual behaviors but also sexual experiences associated with desire/pleasure which have been systematically neglected when investigating the sexual and reproductive health of the youth. This study was conducted with a representative sample of the adolescents attending public high schools in the State of Caldas in the Republic of Colombia. The third study was a qualitative analysis of 22 interviews conducted with male and female U.S. Latino adolescents on the reasons for having had or having not had vaginal sex. The more relevant results were: most current adolescent sexual health prevention programs are still framed in a negative approach to adolescent sexuality developed a century ago by Stanley Hall and Sigmund Freud which do not accept the adolescent sexual experience and propose its sublimation. In contrast, the Colombian study indicates that, although there are gender differences, adolescence is for males and females a normal period of sexual initiation not limited to coital activity, in which sexual desire/pleasure is strongly associated with sexual behavior. By the same token, the study about the reasons for having had or not had initiated heterosexual intercourse indicated that curiosity, sexual desire/pleasure, and love are basic motivations for deciding to have vaginal sexual intercourse for the first time and that during adolescence, young women and men reach the cognitive development necessary for taking conscious decisions about their sexual acts. The findings underline the importance of asking pertinent questions about desire/pleasure when studying adolescent sexuality and adopting an evidence-based approach to sexual health interventions.^

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Background. The United States continues to have the highest rates in teenage pregnancy among industrialized nations and approximately 46% of high school students engaged in sex by the time they graduated. Various family adolescent processes (family connectedness, perceived parental beliefs about sex, parent-child communication about sex) have been linked to adolescent sexual behavior. However, the association between family adolescent and adolescent sexual intentions has not often been studied in middle school minority youth.^ Methods. Research hypotheses were tested using a secondary data analysis from a HIV, STI, and pregnancy prevention program for urban middle school students.^ Results. At baseline, 77% of students reported low intentions to engage in vaginal or oral sex within a year and 87% reported they would use a condom if having sex within the next 3 months. After adjusting for gender, age, and race/ethnicity, family connectedness and perceived parental beliefs about sex were significantly associated with vaginal and oral sex intentions. Only perceived parental beliefs was associated with condom use intentions. ^ Conclusions. Family adolescent processes appear to be associated with adolescents’ intentions regarding sex and condom use. Early interventions are needed that take into account the importance of healthy, supportive parent-adolescent relationships and encourage parents to share their beliefs about sex to adolescents before the onset of sexual activity. ^

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This dissertation utilized quantitative and qualitative methods to examine the role of responsibility in the prevention of sexually transmitted infections (STIs) and pregnancy through condom use and other sexual behaviors among young adolescents. Data were analyzed across race and gender and three papers were developed. The quantitative portion used logistic regression to assess associations between personal responsibility, as well as other know correlates, and reported condom use and condom use intentions as a means of STI and pregnancy prevention among 445 inner-city, high school adolescents. Responsibility to prevent pregnancy by providing the condom was associated with condom use at last sex and consistent condom use. Responsibility to prevent acquiring a STI by using a condom was significantly associated with consistent condom use. No significant associations were found between responsibility and condom use intentions. ^ The qualitative section of the dissertation project involved conducting 28 in-depth interviews among 9th and 10th grade, African American and Hispanic students who attended a large urban school district in South Central Texas. Perceptions of responsibility for preventing STIs and unintended pregnancy, as well as for condom use, were explored. Male and female adolescents expressed joint responsibility to prevent a STI or pregnancy. Perceptions of responsibility for providing and using the condoms were mixed. Despite the indication of both partners, mostly all participants implied that females, more so than the males, had the final responsibility to prevent contracting a STI, a pregnancy, to provide a condom, and to make sure a condom was used. Participants expressed the role of parents' involvement for preventing these outcomes as well as the need for more sexual health education and access to preventative methods. ^ The last section of this dissertation involved qualitative inquiry to ascertain perceptions of reasons why adolescents engage in anal and oral (non-coital) sex. Pleasure-seeking and giving as well social influence and pressure were described as the main reasons why teenagers have non-coital sex. Other reasons included conveniences of participating in these behaviors such as ease of performing oral sex and anal sex as a convenient alternative to vaginal sex. Sexual inexperience was an indicator for why anal sex occurs. Many of the reasons involved misperceptions and adolescents who practice these sexual behaviors place themselves at-risk for contracting a STI. ^ This dissertation increased the current knowledge base about adolescent sexual responsibility and non-coital behaviors. Future studies should explore perceptions of responsibility and actual sexual activity practices among adolescents to reduce the burden of STIs and pregnancy as well as help public health professionals develop programs for adolescent populations, schools, and communities where these issues persist.^

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"Slow Learners" is a term used to describe children with an IQ range of 70-89 on a standardized individual intelligence test (i.e. with a standard deviation of either 15 or 16). They have above retarded, but below average intelligence and potential to learn. If the factors associated with the etiology of slow learning in children can be identified, it may be possible to hypothesize causal relationships which can be tested by intervention studies specifically designed to prevent slow learning. If effective, these may ultimately reduce the incidence of school dropouts and their cost to society. To date, there is little information about variables which may be etiologically significant. In an attempt to identify such etiologic factors this study examines the sociodemographic characteristics, prenatal history (hypertension, smoking, infections, medication, vaginal bleeding, etc.), natal history (length of delivery, Apgar score, birth trauma, resuscitation, etc.), neonatal history (infections, seizures, head trauma, etc.), developmental history (health problems, developmental milestones and growth during infancy and early childhood), and family history (educational level of the parents, occupation, history of similar condition in the family, etc.) of a series of children defined as slow learners. The study is limited to children from middle to high socioeconomic families in order to exclude the possible confounding variable of low socioeconomic status, and because a descriptive study of this group has not been previously reported. ^

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The study objectives were to determine risk factors for preterm labor (PTL) in Colorado Springs, CO, with emphasis on altitude and psychosocial factors, and to develop a model that identifies women at high risk for PTL. Three hundred and thirty patients with PTL were matched to 460 control patients without PTL using insurance category as an indirect measure of social class. Data were gathered by patient interview and review of medical records. Seven risk groups were compared: (1) Altitude change and travel; (2) Psychosocial ((a) child, sexual, spouse, alcohol and drug abuse; (b) neuroses and psychoses; (c) serious accidents and injuries; (d) broken home (maternal parental separation); (e) assault (physical and sexual); and (f) stress (emotional, domestic, occupational, financial and general)); (3) demographic; (4) maternal physical condition; (5) Prenatal care; (6) Behavioral risks; and (7) Medical factors. Analysis was by logistic regression. Results demonstrated altitude change before or after conception and travel during pregnancy to be non-significant, even after adjustment for potential confounding variables. Five significant psychosocial risk factors were determined: Maternal sex abuse (p = 0.006), physical assault (p = 0.025), nervous breakdown (p = 0.011), past occupational injury (p = 0.016), and occupational stress (p = 0.028). Considering all seven risk groups in the logistic regression, we chose a logistic model with 11 risk factors. Two risk factors were psychosocial (maternal spouse abuse and past occupational injury), 1 was pertinent to maternal physical condition ($\le$130 lbs. pre-pregnancy weight), 1 to prenatal care ($\le$10 prenatal care visits), 2 pertinent to behavioral risks ($>$15 cigarettes per day and $\le$30 lbs. weight gain) and 5 medical factors (abnormal genital culture, previous PTB, primiparity, vaginal bleeding and vaginal discharge). We conclude that altitude change is not a risk factor for PTL and that selected psychosocial factors are significant risk factors for PTL. ^

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The occurrence of group G streptococci in cats and evaluation of the recovered organisms as potential human pathogens was investigated. Throat swabs were obtained from 89 cats (47 males and 42 females) and vaginal swabs from 39 female cats. Eighty-three of the examined cats were housed in individual cages at a University Animal Care Facility. Six cats, 2 mature males, 2 mature females and 2 young females were family pets in a rural area. Beta-hemolytic streptococci were recovered from 33 (37%) of the 89 cat throats cultured, and 27 (30.3%) were identified as group G. More males (34%) than females (24%) had throat cultures positive for group G. From the 39 vaginal cultures examined, 24 (61.5%) contained beta-hemolytic streptococci and 23 (58.9%) were identified as group G streptococci. Streptococci were not recovered from the vaginal cultures of the 5 females under 6 months of age.^ Thirty one group G streptococci isolated from cats were compared with 37 isolates of group G obtained from humans (health status or site of origin unknown). More group G cat isolates (81%) produced deoxyribonuclease (DNase) than did the human isolates (36%). The proportion of cat throat and vaginal isolates producing DNase was the same. Production of nicotinamide adenine dinucleotide glycohydrolase (NADase) by group G isolates of human origin was 70%, cat throat isolates 53% and cat vaginal isolates 37%. The Serum Opacity Factor was present in 73% of the cat throat isolates of group G, 43.7% of the cat vaginal isolates and 58.6% of the human isolates. Possession of an anti-phagocytic factor (M protein like substance) demonstrated by the ability to multiply in fresh human blood was greater in the group G from cat throats (46.7%) than from cat vagina (37.5%) or from the human isolates (13.5%). Many of the biochemical characteristics of the group G streptococci of cat origin were more similar to the biochemical characteristics of group A streptococci, than to the characteristics of group G of human origin. The group G streptococci, found in a large number of cats, could be potential human pathogens, as their physiological and biological characteristics are very similar to those of group A, a known human pathogen. ^

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Early and accurate detection of TB disease in HIV-infected individuals is a critical step for a successful TB program. In Vietnam, the diagnosis of TB disease, which is based predominantly on the clinical examination, chest radiography (CXR) and acid fast bacilli (AFB) sputum smear, has shown to be of low sensitivity in immunocompromised patients. The sputum culture is not routinely performed for patients with AFB negative smears, even in HIV-infected individuals.^ In that background, we conducted this cross-sectional study to estimate the prevalence of sputum culture-confirmed pulmonary tuberculosis (PTB), smear-negative PTB, and multidrug-resistant TB (MDR-TB) in the HIV-infected population in Ho Chi Minh City (HCMC), the largest city in Vietnam where both TB and HIV are highly prevalent. We also evaluated the diagnostic performance of various algorithms based on routine available tools in Vietnam such as symptoms screening, CXR, and AFB smear. Nearly 400 subjects were consecutively recruited from HIV-infected patients seeking care at the An Hoa Clinic in District 6 of Ho Chi Minh City from August 2009 through June 2010. Participants’ demographic data, clinical status, CXR, and laboratory results were collected. A multiple logistic regression model was developed to assess the association of covariates and PTB. ^ The prevalence of smear-positive TB, smear-negative TB, resistant TB, and MDR-TB were 7%, 2%, 5%, 2.5%, and 0.3%, respectively. Adjusted odds ratios for low CD4+ cell count, positive sputum smear, and CXR to positive sputum culture were 3.17, 32.04, and 4.28, respectively. Clinical findings alone had poor sensitivity, but the combination of CD4+ cell count, sputum smear, and CXR proved to perform a more accurate diagnosis.^ This study results support the routine use of sputum culture to improve the detection of TB disease in HIV-infected individuals in Vietnam. When routine sputum culture is not available, an algorithm combining CD4+ cell count, sputum smear, and CXR is recommended for diagnosing PTB. Future studies on more affordable, rapid, and accurate tests for TB infection would also be necessary to timely provide specific treatments for patients in need, reduce mortality, and minimize TB transmission to the general population.^

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Because Hispanic women are even less likely than women of other ethnic groups to receive early prenatal care, the purpose of this study was to identify factors that may influence these women to initiate care. After giving consent, 300 Hispanic women (100 who initiated first trimester care, 100 who initiated second trimester care, and 100 who initiated third trimester care or received no care) were interviewed in the post partum unit of a local public hospital. The interview included recollection of events leading to the first prenatal appointment, including first physical indicators of pregnancy, confirmation of pregnancy, feelings about the pregnancy, appointment making behavior, and system barriers encountered. The Health Belief Model was used as the theoretical framework for determining psychosocial variables. Using this model, perceived susceptibility to problems during pregnancy, perceived seriousness of possible problems, perceived benefits of prenatal care, perceived barriers to care, and cues to action were assessed. Time of entry into prenatal care was assessed by interview.^ In this sample of low-income Hispanic women, a higher perception of barriers to care was associated with later initiation of care and non-use of care, higher perceived benefits of care for the baby were associated with earlier care, especially in women without a card to access hospital district services, and having a card to access hospital district services was associated with earlier care. Several barriers to care were mentioned by women on open-ended questioning including long waiting times, embarrassment, and lack of transportation.^ Recommendations for practice included decreasing the number of visits for low-risk women while increasing the time spent with the provider, decreasing the number of vaginal exams for low-risk women, increasing the use of midwives, training lay workers to do risk assessment, giving specific messages about benefits of care to baby, and increasing general health motivation through community intervention methods. More research on the psychosocial and cultural factors associated with initiation of care is needed. In the meantime, the recommendations for practice can be implemented now to increase the use of prenatal care by low-income Hispanic women. ^

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La práctica de profesiones relacionadas con la salud se asocia a agotamiento físico y psicológico capaz de producir alteraciones en el plano de la sexualidad. Mediante una encuesta estructurada y anónima se valoró el grado de satisfacción respecto a la calidad de vida sexual y los factores relacionados con esta en médicos, residentes y enfermeros. El 62% afirmó que desde el inicio de la actividad laboral disminuyó la frecuencia y calidad de las relaciones sexuales, primordialmente en residentes (69.3%) (p<0.05) y mujeres (61%), el 33.1% refirió mayor atracción por otras personas y 15% infidelidad. El 71.8% consideró que la frecuencia no era óptima, el 48.6% no estaba satisfecho y el 37.3% que la pareja no estaba conforme con su desempeño sexual. Las mujeres utilizan más pretextos para evitar la relación sexual (22.6 vs. 6.1%), consideran que satisfacen menos a sus parejas (45 vs. 22%) y tienen orgasmos menos frecuentemente (22 vs. 8%) que los hombres (p< 0.05) y estos son más infieles (24.5 vs. 9.7%) (p< 0.05). Los residentes refieren que la frecuencia y calidad sexual disminuyó más con el inicio del trabajo (71.8 vs. 46.7%) (p<0.05), atribuido principalmente al cansancio extremo y se sienten más atraídos por compañeros de trabajo que los médicos de planta (24 vs. 2%) (p<0.05). El cuidado de la salud es un determinante de riesgo de disfunción sexual causado por las demandas y condiciones laborales, que genera un alto grado de estrés y desgaste psicofísico, que conducen a un deterioro de la salud sexual.

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Background: Postpartum hemorrhage (PPH) remains a major killer of women worldwide. Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available. Misoprostol's potential as a treatment option for PPH is increasingly known, but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen. This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment. Methods: A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants. Results: Due to a much lower rate of PPH than expected (1.2%), only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or maternal deaths among study participants. The rate of transient shivering and fever was significantly higher among women receiving misoprostol Conclusion: A 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH. Trial Registration: Clinical trials.gov, Registry No. NCT00116480