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Purpose of Study: To study the predictive accuracy of maternal characteristics, mean arterial pressure, uterine artery doppler and maternal ophthalmic artery doppler in second trimester for subsequent development of pre-eclampsia. Methods: A prospective cohort study of 440 women at 19-24 weeks' gestation. It included recording of maternal demographic characteristics and calculation of HDP Gestosis Score, measurement of MAP and ultrasound evaluation for fetal anatomy, Uterine artery doppler and maternal ophthalmic artery doppler. The mean Peak Systolic Velocity ratio was obtained by taking two sets of reading from both eyes. The statistical analysis was done using independent t-test for quantitative variables and chi-square test, Fisher's exact test for qualitative variables and Area Under Curve was obtained at 10% False Positive Rate. Results: Among 440 pregnant women, 43(10.8%) developed Hypertensive Disorder of Pregnancy (8 early onset PE, 16 late onset PE and 19 GHTN) and 42 were lost to follow up, with an incidence rate of 10.8%. Combination of Gestosis Score + OAD PSV Ratio had highest AUC of 0.73. Whereas combination of Gestosis Score + MAP + UtAPI + OAD-PSV Ratio had highest sensitivity of 97.67%. The OAD PSV ratio improved detection rate of Gestosis Score (from 90 to 100%) for prediction of development of PE, especially Preterm PE at 10% FPR. Conclusion: Maternal Ophthalmic artery doppler study significantly improved prediction of development of PE at 19-24 weeks' gestation, both independently as well as in combination with HDP-Gestosis Score, MAP and uterine artery doppler.
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BACKGROUND: The progestogen component of combined oral contraceptives (COC) has undergone changes since it was first recognised that it's chemical structure could influence the spectrum of minor adverse and beneficial effects. The major determinants of effectiveness are compliance and continuation which may be influenced by cycle control and common side effects. The rationale of this review is to provide a systematic comparison of COCs containing the progestogens currently in use worldwide. OBJECTIVES: To compare currently available low-dose COCs containing ethinyl estradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. SEARCH STRATEGY: A search of PubMed, LILACS, EMBASE, Popline, CINAHL and the Cochrane Central Register of Controlled Trials databases was conducted in September 2010 to update the 2004 review. SELECTION CRITERIA: Randomised trials reporting clinical outcomes were considered for inclusion. We excluded studies comparing monophasic with multiphasic pills, crossover trials, trials in which the difference in total content of ethinyl estradiol between preparations exceeded 105 µg per cycle and those comparing continuous dosing regimens. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality, applied inclusion criteria and extracted data. MAIN RESULTS: Thirty trials with a total of 13,923 participants were included, generating 16 comparisons. Overall the quality of trials was low. Only four trials were double-blind. At least twenty-three trials were sponsored by pharmaceutical companies. There was less discontinuation with second-generation compared with first-generation monophasic progestogens (3 trials, 2,709 women, Relative Risk (RR) 0.76, 95% Confidence Interval (CI) 0.67-0.86); this remained significant when only double-blind trials were considered (812 women, RR 0.79, 95% CI 0.66-0.94).Women using monophasic COC's containing third-generation progestogens were less likely to discontinue than the second-generation group (3 trials, 1,815 women, RR 0.77, 95% CI 0.60-0.98) but this was not significant when only double-blind trials were considered (RR 0.79, 95% CI 0.50-1.26]. Women in the third-generation group experienced less intermenstrual bleeding than the second-generation group (one double-blind trial, 456 women, RR 0.71, 95% CI 0.55-0.91).Compared to desogestrel (DSG), women in the drospirenone (DRSP) group were more likely to complain of breast tenderness (5 trials, 4,258 women, RR 1.39, 95% CI 1.04-1.86) and nausea (6 trials, 4,701 women, RR 1.46, 95% CI 0.96-2.21].Pregnancy rates overall were comparable but the trials had insufficient power to find potentially important differences. AUTHORS' CONCLUSIONS: Women using COCs containing second-generation progestogens may be less likely to discontinue than those using COCs containing first-generation progestogens. Based on one small double-blind trial, third-generation progestogens may be preferable to second-generation preparations with regard to bleeding patterns but further evidence is needed. Without blinding as to treatment group, comparisons between the various "generations" of progestogens used in COCs cannot be made. Until this widespread methodological flaw is overcome in better trials conducted according to CONSORT guidelines and internationally accepted definitions, no further conclusions can be drawn.
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Anticoncepção/métodos , Anticoncepcionais Orais Combinados/administração & dosagem , Progestinas/administração & dosagem , Química Farmacêutica , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Combinados/química , Etinilestradiol/administração & dosagem , Etinilestradiol/efeitos adversos , Etinilestradiol/química , Feminino , Humanos , Adesão à Medicação/estatística & dados numéricos , Progestinas/efeitos adversos , Progestinas/química , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: WHO states that obstetric hemorrhage, hypertensive disorders of pregnancy and sepsis account for approximately 50% of maternal deaths worldwide. All these conditions are associated with changes in vital signs including blood pressure (BP) and heart rate (HR). Shock index (SI) is the ratio of HR to systolic BP. AIMS AND OBJECTIVES: To evaluate role of shock index as an early indicator of adverse maternal outcomes and to determine the threshold points of SI for five adverse maternal outcomes. METHODOLOGY: This was a prospective observational study on 1004 consecutively enrolled subjects presenting in labor. Vital signs and Shock Index were recorded. SI thresholds were analyzed with respect to obstetric complications and adverse outcomes. Parametric tests such as Chi-square, comparison of proportions, comparison of mean and ROC curve analysis were applied on the data. RESULTS: The mean SI value in the vaginal delivery group was 1.02 ± 0.26 and it was 0.95 ± 0.033 in the caesarean delivery group. The values of SI ((Mean and SD) for ICU admission were (1.23 (± 0.35)), for (MODS) it was (1.47 (± 0.84)), for blood transfusion > 4 units it was (1.15 (± 0.41)), for surgical intervention it was (1.58 (± 0.51)) and for maternal death (1.39 (± 0.85)). SI ≥ 1.4, had sensitivity 26.82% (21.09-33.19); specificity 100%(99.53-100), PPV was 100% and NPV was 82.96%(81.8-84.06)with an AUC of 0.8 (0.78-0.83) on ROC analysis. In subjects with PIH/eclampsia, SI was lower and in patients with severe anemia, SI was higher. CONCLUSION: SI performed well as a screening tool in the prediction of adverse maternal outcomes. SI ≥ 0.9 was significantly associated with maternal adverse outcomes: ICU admission, MODS, surgical intervention, blood transfusion and death. The study proposes an SI cut-off of 0.9 for referral and a cut-off of 1.1 for intervention in a tertiary care hospital. Patients with PIH/eclampsia tend to have lower mean SI values as compared to the rest of the study population, suggesting that SI may not be a reliable indicator in patients with PIH/eclampsia.
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BACKGROUND: There is no consensus about the better intravenous drug between Hydralazine and Labetalol to control hypertension in cases of severe hypertension in pregnancy. Both drugs have their own advantages and disadvantages. METHODS: This is a prospective randomized controlled trial comparing the efficacy and safety of intravenous Labetalol versus Hydralazine for management of severe hypertension in pregnancy. A total of 152 eligible subjects were randomised in two groups consisting 76 subjects each by envelope method. Both the groups were comparable with respect to systolic, diastolic and mean arterial blood pressure at admission. One group received Labetalol and the other Hydralazine. The number of drug doses, the time taken to achieve target blood pressure and side-effects were noted. RESULTS: With a single dose, Labetalol (81.5%) was able to achieve target blood pressure in a significantly higher number of cases as compared to Hydralazine (69.5%). Labetalol could help in achieving the target blood pressure faster than Hydralazine. The incidence of maternal adverse effects was comparable between the groups. Fetal outcome was comparable in both groups. CONCLUSION: Hydralazine and Labetalol both were found to be equally efficacious in reducing blood pressure in cases of severe hypertension in pregnancy. Labetalol achieved the target blood pressure faster than Hydralazine. The adverse effects of both the drugs were comparable.
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BACKGROUND: Attempting vaginal birth after cesarean section (VBAC) places women at an increased risk of complications. Trial of labor after cesarean (TOLAC) calculators aim to predict the chance of successful vaginal birth after cesarean (VBAC) based on the patient's preexisting demographic and clinical factors. OBJECTIVE: To assess the rate of successful TOLAC using two calculators: FLAMM and the Grobman calculator, and to compare the performance of the two calculators in the successful prediction of VBAC. METHODS: Prospective cohort study in subjects with previous one caesarean section using well-defined inclusion and exclusion criteria. RESULTS: A total of 280 subjects with previous one cesarean section were enrolled. One hundred thirty-nine subjects consented for TOLAC, 90 (67%) underwent successful trial of vaginal birth, and 49 (32.8) required cesarean section. Cervical dilatation (p < 0.0001) and effacement (p < 0.0001), and any prior vaginal delivery (p < 0.02) were significantly associated with a successful outcome. At a cutoff score of 5, the sensitivity of the FLAMM score was 72% and specificity was 76%. For the Grobman calculator, the best sensitivity (69%) and specificity (67%) were seen at a cutoff score of 85%. CONCLUSION: Both prediction models, the FLAMM and the "close to delivery" nomogram, recommended by Grobman et al. are easy to use and could successfully estimate the chances of vaginal birth in previous caesarean, in this small cohort. The decision for women opting for TOLAC can be individualized, and patient-specific chances of success can be predicted by the use of these prediction models.
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Background: This study aims to compare the value of the Bishop score and cervical length measurement by transvaginal ultrasonography in predicting active labor within 6 h, induction-to-delivery interval, and the duration of active labor and to estimate the most useful cutoff points for the two methods. Methods: This is a prospective comparative study of Bishop score and cervical length measured by transvaginal sonography on 62 nulliparous subjects who underwent induction of labor. Results: The Bishop score of the subjects ranged from two to seven (2-7). The mean Bishop in this study population was 4.37 + 1.23. The mean cervical length in this study was 25.59 + 6.07. Bishop score was highly significant (P value < 0.0001) in predicting active phase of labor as compared to cervical length (P = 0.004). The best cutoff value for Bishop score to predict induction of labor within 6 h was more than 4 with sensitivity of 69% and specificity of 79%. Similarly, best cutoff value for cervical length to predict induction of labor within 6 h was less than or equal to 25 mm with sensitivity of 51% and specificity of 70%. Bishop score was more significant (P = 0.001) in predicting induction-to-delivery interval within 12 h as compared to cervical length (P = 0.01). Conclusion: The Bishop score was superior in predicting the response to induction as compared to the cervical length measured by transvaginal ultrasonography.
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The Fertility Regulation Group of the Cochrane Collaboration has been assessing the best available evidence on fertility regulation, family size and birth spacing. By the end of 2005, this group had published 32 systematic reviews and 12 protocols; most reviews were on contraception. Because of suboptimal trial quality, firm conclusions could be made in only five reviews. Threats to internal validity in published trials include the absence of description of allocation concealment, intentional exclusion of participants after randomization, failure to use intention-to-treat analyses and lack of treatment blinding. The precision of results has been limited by small sample sizes. The finding that most trials of oral contraceptives were conducted by pharmaceutical companies raises concerns about potential commercial bias. Of necessity, most information about fertility regulation effectiveness and adverse effects comes from observational studies, which vary widely in quality. Systematic reviews of evidence, with an emphasis on randomized controlled trials when available, will continue to improve fertility regulation in the years ahead.
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Ensaios Clínicos como Assunto , Serviços de Planejamento Familiar , Educação Sexual/métodos , Aconselhamento/métodos , Indústria Farmacêutica/ética , Serviços de Planejamento Familiar/organização & administração , Feminino , Fertilidade/efeitos dos fármacos , Fertilidade/fisiologia , Humanos , Masculino , Reprodutibilidade dos TestesRESUMO
BACKGROUND: This study was conducted to evaluate how the preeclampsia integrated estimate of risk (fullPIERS) model performs in the prediction of adverse maternal outcomes when the predictor variables are all obtained within 24-h of admission for preeclampsia. METHODS: A prospective cohort study on 323 women who fulfilled definite inclusion and exclusion criteria was conducted. Subjects were monitored for clinical symptoms of preeclampsia, biochemical parameters, and adverse maternal and neonatal outcomes. A risk prediction score was calculated using the fullPIERS calculator. Statistical analysis of rates and ratios was carried out by assessing χ (2) test and odds ratio. RESULTS: 18.3 % (n = 60) had adverse maternal outcome and 42.8 % (n = 138) had adverse fetal outcome, and 43 (13.35 %) had combined adverse maternal and perinatal outcome. Dyspnea, visual disturbances, epigastric pain, and [Formula: see text] appeared to be highly significant risk factors. In the biochemical variables studied, serum creatinine and serum uric acid were found to have a significant association. The association between adverse perinatal outcome and vaginal delivery was highly significant (OR 0.35, 95 % CI 0.19, 0.63), and the P value was 0.0005. The likelihood ratio associated with the highest risk group (predicted probability of the outcome ≥30 %) showed excellent performance (i.e., 17.5) of fullPIERS model as a rule in test. CONCLUSION: The fullPIERS model performed well in the prediction of adverse maternal outcomes in women with preeclampsia. It is easy to use. The model is based on the use of few important clinical and biochemical parameters and does not require extensive laboratory testing. Although it might be of limited use in a well-equipped tertiary care facility, this model can be utilized in the setting of district or sub-district level hospitals to identify patients who are at risk of complications due to preeclampsia. Timely referral to a higher center will help in reducing the morbidity and mortality associated with this condition.
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ABSTRACT: Antepartum stillbirths are a major contributor to perinatal mortality. This study was undertaken to assess the role of the ReCoDe (relevant condition at birth) classification system in evaluation of stillbirths in a tertiary teaching hospital in Central Gujarat. AIM: To determine etiology of stillbirths using the ReCoDe classification system. MATERIALS AND METHODS: This was a prospective case control study over a period of 1 year from September 1st, 2012 to August 31st, 2013. Sample size was calculated as 243 cases and 486 controls. Two controls (live births) per case were matched for gestational age and birth weight. Odd's ratios with 95 % confidence intervals were calculated using multivariate logistic regression. RESULTS: Maternal age and parity that appeared to be highly significant factors on univariate analysis were not found to be independent risk factors with multivariate logistic regression. Gestational age and birth weight were not statistically significant risk factors. Other risk factors like previous stillbirth (26.13; 95 % CI 3.23-211.29), antepartum hemorrhage (11.63; 95 % CI 3.83-35.30), and hypertensive disorders (2.09; 95 % CI 1.20-3.63) were found to be highly significant independent risk factors. Major congenital anomaly (P < 0.001), birth asphyxia (P = 0.0037), cord accidents (P = 0.0037), and rupture uterus (P = 0.001) were also highly significant. CONCLUSION: The stillbirth rate was 87.83 per 1000 live births. The ReCoDe primary classification system enabled 74.1 % of the cases to be assigned a relevant condition, leaving only 25.9 % as unexplained. The single largest condition associated was fetal growth restriction (25.9 %).
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BACKGROUND: To examine Cesarean delivery rates based on the Robson's Ten-group classification system (TGCS), over a 10-year period. METHODS: All Vaginal Deliveries and cesarean sections (CSs) performed over a 10-year period from 2004 to 2013 were included in the analysis. The data were compiled according to Robson's TGCS of cesarean section for every year. Risk Ratios (crude RRs) with 95 % confidence intervals for delivery by cesarean section were calculated for each Robson's group. RESULTS: The TGCS was easily applied in this large dataset of 40,086 deliveries. The 10-year overall cesarean section rate (CSR) was 25.17 %. Groups 1 and 3 represented 60 % of the total obstetric population. The largest contributions to the total CSR are group 1 (37.62 %) and group 5 (17.06 %). Group 3 which was the second largest group contributed 15 % to the overall CSR. Group 2 and group 4 had high group CSRs of 47.28 and 34.74 % respectively, although the total group size was small (n = 1375;3.43 %). Maternal age and presentation were found to have an independent association with mode of delivery on logistic regression. CONCLUSION: The Ten-group classification helped to identify the main groups of subjects who contribute most to the overall CSR. It also helped to identify subgroups requiring closer monitoring for more in-depth analyses of the indications for caesarean section. It is important to focus on the first four TGCS groups which constitute about 75 % of all deliveries. It is in the low-risk groups that one is likely to find the highest and most inappropriate indications for cesarean sections.
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BACKGROUND: The discrimination between benign and malignant adnexal masses is central to decisions regarding clinical management and surgical planning in such patients. PURPOSE OF STUDY: To determine if the RMI (RMI 2) can distinguish between benign and malignant adnexal masses. METHODS: A prospective cohort study was conducted of 58 women with an adnexal mass referred to a teaching hospital for diagnosis and management. RESULTS: RMI > 200 had a sensitivity of 70.5 % (95 % CI 46.87-86.72), a specificity of 87.8 % (95 % CI 74.46-94.68), a positive predictive value of 70.5%, and negative predictive value of 87.8 %. ROC showed that cut off value of 25 achieved a sensitivity and specificity of 82.35 and 43.9 %, respectively, and a cut off value of 1,000 gave a sensitivity and specificity of 58.81 and 97.56 %, respectively. The association between RMI and disease status was not statistically significant for mucinous tumors. CONCLUSION: RMI is a reliable tool in differentiating benign from malignant adnexal masses. It is simple, easy to use and cost effective. However it's predictive accuracy was less for mucinous as compared to serous epithelial ovarian cancers. The study is limited by its small sample size.
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BACKGROUND: The progestogen component of oral contraceptives (OCs) has undergone changes since it was recognized that their chemical structure can influence the spectrum of minor adverse and beneficial effects. METHODS: The objective of this review was to evaluate currently available low-dose OCs containing ethinylestradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. The Cochrane Controlled Trials Register, MEDLINE and EMBASE databases were searched. Randomized trials reporting clinical outcomes were considered for inclusion and were assessed for methodological quality and validity. RESULTS: Twenty-two trials were included in the review. Eighteen were sponsored by pharmaceutical companies and in only 5 there was an attempt for blinding. Most comparisons between different interventions included one to three trials, involving usually less than 500 women. Discontinuation was less with second-generation progestogens compared to first-generation (RR 0.79; 95% CI 0.69-0.91). Cycle control appeared to be better with second-compared to first-generation progestogens for both, mono-and triphasic preparations (RR 0.69; 95% CI 0.52-0.91) and (RR 0.61; 95% CI 0.43-0.85), respectively. Intermenstrual bleeding was less with third- compared to second-generation pills (RR 0.71; 95% CI 0.55-0.91).Contraceptive effectiveness of gestodene (GSD) was comparable to that of levonorgestrel (LNG), and had similar pattern of spotting, breakthrough bleeding and absence of withdrawal bleeding). Drospirenone (DRSP) was similar compared to desogestrel (DSG) regarding contraceptive effectiveness, cycle control and side effects. CONCLUSION: The third- and second-generation progestogens are preferred over first generation in all indices of acceptability. Current evidence suggests that GSD is comparable to LNG in terms of contraceptive effectiveness and for most cycle control indices. GSD is also comparable to DSG. DRSP is comparable to DSG. Future research should focus on independently conducted well designed randomized trials comparing particularly the third- with second-generation progestogens.
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INTRODUCTION: Cervical cancer is the most common cancer among Indian women. Only 5 % of women in developing countries have ever been screened for cervical abnormalities. OBJECTIVES: To study the correlation of cytology and colposcopy in VIA-positive women attending the Gynaecology clinic. MATERIALS AND METHODS: This prospective cross-sectional study on 200 symptomatic women compares the role of cytology and colposcopy in the assessment of subjects testing positive for acetowhite lesions on the cervix after application of 5 % acetic acid (VIA). RESULTS: 200/637 women screened in OPD tested VIA positive, giving a positivity rate of 31 %. Six smears were reported as LGSIL or HGSIL giving a cytological abnormality rate of 3 %. The association between cytology and Reid's score was statistically significant at a p value of 0.02. Of the 4 cases with biopsy-confirmed invasive cancer, cytology reported 2 as LGSIL and 2 as HGSIL. Colposcopy reported all these women as CIN 2/3. CONCLUSION: The accuracies of Pap smear cytology and colposcopy in the diagnosis of precancerous and cancerous lesions of cervix were good.
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OBJECTIVE: To determine the clinical value of uterine artery Doppler Pulsatility index (PI) at 22-24 + 6 weeks scan and importance of maternal history and mean arterial pressure (MAP) in the prediction of pre-eclampsia. MATERIALS AND METHODS: This was a prospective screening study of 200 women with singleton pregnancy. Maternal history and blood pressure were recorded, and MAP was calculated. Transabdominal Doppler ultrasound of uterine artery was performed. Mean PI was calculated, and the presence or the absence of bilateral early diastolic notch was noted. Women were then followed up through pregnancy and delivery for the development of pre-eclampsia, gestational hypertension, and SGA. RESULTS: The mean ± SD PI value for subjects who had an adverse pregnancy outcome was significantly higher (0.84 ± 0.28) than mean ± SD PI value for subjects who had normal pregnancy outcome (0.71 ± 0.16) with P value <0.000. CONCLUSION: Second trimester uterine artery Doppler is a useful screening method for identification of high risk pregnancy in women who can be kept under close surveillance for better maternal and neonatal outcome. This test works better when combined with previous history of pre-eclampsia and MAP.
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OBJECTIVE: To assess maternal cardiovascular function using echocardiography in normal and preeclamptic women in the third trimester of pregnancy. METHODS: 40 subjects, 20 with preeclampsia and 20 normotensive controls with >34 weeks gestation and singleton pregnancy were recruited. Baseline characteristics, maternal and fetal outcome were studied with systolic and diastolic parameters on echocardiography. RESULTS: The following parameters were higher in preeclamptic subjects as compared to normotensive controls-mean cardiac output (66.85 ± 4.56 ml/min vs. 56.1 ± 1.77 ml/min); mean LV diastolic mass (131.15 ± 16.85 vs. 104.90 ± 23.17 g); systolic mass (88.5 ± 7.34 vs. 83.33 ± 23.84 g); total vascular resistance (1396.85 ± 150.2 vs. 1204.5 ± 71.182 dyne, s cm(5)). Women with preeclampsia delivered smaller babies (2410 ± 426.16 g) as compared to normotensive controls (2895 ± 276.20 g). Student 't' test was used as a test of significance. CONCLUSION: Women with preeclampsia have significant systolic and diastolic dysfunction compared to normotensive controls. Blood pressure monitoring alone is insufficient to identify effectively, risk of cardiovascular complications in these subjects.
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BACKGROUND: Up to two-thirds of individuals acquire herpes asymptomatically and most infected persons shed the virus during latency periods. Genital infection is frequently associated with the presence of other sexually transmitted diseases. The objective of this paper was to assess the seroprevalence of HSV-2 in a low risk population and to validate the use of reported symptoms and clinical signs as a possible diagnostic tool to screen for HSV-2. METHODS: One hundred and fifty consecutive women presenting for the first time to the Gynecology outpatient clinic with complaints of vaginal discharge, lower abdominal pain, genital warts or ulcers were enrolled over a period of 4 months. Samples were taken and laboratory tests were performed to evaluate the presence of common reproductive tract infections including HSV-2. RESULTS: In this study, using a validated type specific assay, we found an unexpected high prevalence of HSV-2 (35 subjects, 23.3%). Of the 147 women who presented with the symptom of vaginal discharge, 34 (23.1%) tested positive for HSV-2. On examination cervical erosion and tenderness was noted in 50 women, in 23 (46%) of whom HSV-2 tested positive. On univariate analysis, no significant association was found between selected demographic factors, STIs and NSTIs and HSV-2. The association between previous abortion and HSV-2 was however, statistically significant. Also, none of the women who had HSV-2 positivity tested positive for HIV. CONCLUSION: The high HSV-2 seroprevalence in this low risk population may indicate a high risk for future acquisition of HIV in this population. Cervical erosion and hypertrophy as a possible clinical marker for HSV-2 has low positive predictive value and cannot be recommended as a possible diagnostic tool to screen for HSV-2 in resource poor settings.