Safety and efficacy of a new imidazole fungicide, Sertaconazole, in the treatment of fungal vulvo-vaginitis: a comparative study using Fluconazole and Clotrimazole.

Background: Sertaconazole is a new imidazole fungicide introduced for vulvo-vaginal candidiasis. It has an azole group with benzothiophene that inhibits biosynthesis of ergosterol and brings about a massive leak of cytoplasm with consequent fungal cell death. Objective: Assess the safety and efficacy of Sertaconazole in the treatment of fungal vulvo-vaginitis for comparison with Fluconazole and Clotrimazole. Subjects and methods: One-hundred eighty-eight outpatients with fungal vulvo-vaginitis were recruited at Siriraj Hospital, Thailand between August 31, 2004 and January 30, 2006. The patients were given Sertaconazole, Fluconazole, or Clotrimazole, and received vaginal swab and culture for fungus at seventh and 28th days after treatment. Results: Out of 188 cases, 177 cases were followed-up completely. Sertaconazole group included 66 cases where 35 cure, 20 fail, and 7 recurrent cases. Fluconazole group included 60 cases and had 37 cure, six fail, and 20 recurrence cases. Clotrimazole group included 55 cases and had 32 cure, nine fail and 11 recurrent cases. There were risk factors of fungal vulvo-vaginitis, including frequent micturition and small toilet shower flushing. Conclusion: Sertaconazole had similar effectiveness and less side-effect as compared with Fluconazole and Clotrimazole. It appeared to work well with lowest recurrence.

Operational Research for STD Service: Improvement of Treatment and Care at Siriraj Hospital.

Objective: Operational research for sexually transmitted disease (STD) service was conducted to: 1) create the potential for systematic care: to assess and monitor for HIV and STI; 2) create the linkage among OB-GYN, Medicine and Pediatric Departments of Siriraj Hospital; 3) cervical cancer screening in HIV-infected females by Pap smear once a year; 4) create a system file for collection of STI data of the unit; 5) promote HIV counseling, disclosure and keep records; 6) promote condom usage and reduce risk behaviors of HIV-infected females continuously. Methods: HIV positive females attending STD Clinic, Department of Obstetrics & Gynecology, Siriraj Hospital were enrolled in to the study during March 1, 2005 to September 1, 2006. The procedures include: 1) provide STI testing/treatment, risk-reduction and HIV disclosure counseling, provision of free condoms, and cervical cancer screening at least once a year; 2) develop standardized procedures and data collection tools and strengthen data management; 3) refer women from different departments to the STI clinic for screening; 4) provide training in risk reduction counseling and HIV disclosure counseling. Results: Most of the primary visits were check-up. Chlamydial infection was 2.1% (year 2005). GC infection was 0.5% (year 2005). Abnormal Pap was significantly related to low CD4 count. L-SIL = 9.3%; H-SIL = 26.8%. Among the participants, 10.4% had CD4 count <200. Conclusion: Early detection and treatment of STI is 30%. Early detection of cervical cancer and treatment were increased. Access to ARV for HIV-1 PMTCT was also increased. Cross sectional analysis will show more realistic data since the follow up visit may be a group who came to receive condoms which could be missed as high condom use rate. KPI of success in good clinical tracer include increased condom use and CD4 count, decrease STI, opportunistic infection, and viral load.

Prevalence of bacterial vaginosis in Thai women attending the family planning clinic, Siriraj Hospital.

OBJECTIVES: To investigate the prevalence of bacterial vaginosis (BV) among Thai women attending a family planning clinic and to evaluate the association of BV with potential risk factors. MATERIAL AND METHOD: A cross sectional prevalence study was conducted among 800 women attending the family planning clinic, Siriraj Hospital, between August and December 2003. BV was diagnosed according to Amsel's criteria. Prevalence and risk factor models were compiled and statistically analyzed RESULTS: Among the low risk population acquiring sexually transmitted diseases, the prevalence of BV was 14.6% (117 of 800). Asymptomatic disease was recognized in up to 47.9% (56 of 117). BV was significantly more prevalent among those who used douching inside the vagina [OR = 3.98 (1.85-8.33), p < 0.01] and high a prevalence among IUD users [OR = 1.84 (1.22-2.79), p < 0.01]. Although not statistically significant, BV tended to be more prevalent among women with a lower age at first intercourse, higher numbers of lifetime partners, higher frequency of sexual intercourse and current smokers. CONCLUSION: BV is a relatively high prevalent condition. The two potential risk factors, douching inside the vagina and IUD use, can be demonstrated, adding to be more concerned about the inappropriate practice of douching and more consideration in IUD users. The other potential risk factors, the impact to adverse reproductive outcomes and the prevention of BV need further studies, particularly in various Thai populations.

Accuracy of Nugent's score and each Amsel's criteria in the diagnosis of bacterial vaginosis.

OBJECTIVE: To determine the diagnostic accuracy of Nugent's score and each Amsel's criterion in the diagnosis of bacteria vaginosis (BV), considering Amsel's criteria as the gold standard. DESIGN: Cross-sectional, descriptive study (diagnostic test) Setting: Family planning clinic, Siriraj Hospital, Mahidol University. SUBJECTS: A total of 217 women who attended the Family Planning Clinic at Siriraj Hospital between August and December 2003. METHOD: Pelvic examination was performed on each participant. Samples of vaginal discharge was tested for BV infection using both Amsel's criteria and Nugent's score. Interpretation was made blinded without knowledge of each test result. Using Amsel's criteria as a gold standard, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of Nugent's score and each of Amsel's criteria were estimated. RESULTS: Considering Amsel's criteria as the gold standard, Nugent's score showed a sensitivity of 65.6% (95%CI 46.8%, 80.8%), specificity of 97.3% (95%CI 93.5%, 99.0%), positive predictive value (PPV) of 80.8% (95%CI 60.0%, 92.7%), negative predictive value (NPV) of 94.2% (95%CI 89.7%, 96.9%) and accuracy of 92.6% (95%CI 88.1%, 95.6%). Both vaginal pH and whiff test demonstrated 100% sensitivity. However, vaginal pH showed lower specificity than the whiff test (58.9% and 97.3% respectively). CONCLUSION: Nugent's score might not be suitable to use as a screening test for diagnosis of BV due to its low sensitivity. The whiff test is the best clinical criteria of Amsel's criterion in the diagnosis of BV due to its high sensitivity and specitivity.

Associated risk factors of human papillomavirus cervical infection among human immunodificiency virus-seropositive women at Siriraj Hospital.

This cross sectional type sub-study was established to assess the potential risk factor associated with human papillomavirus (HPV) cervical infection in Human immunodeficiency virus (HIV)-seropositive women. The series of 178 HIV-seropositive women was enrolled in the Department of Obstetrics & Gynecology, Siriraj Hospital. Demographic, obstetrical and behavioral risk factors were interviewed. Laboratory results were recorded. Clinical gynecologic examination was performed including Pap smear. The patients were assigned into two groups, HPV and non-HPV group. The comparison of the potential risk factors between the groups was calculated statistically. It was found that the prevalence of HPV infection was reported in 17 patients (9.6%). HIV-seropositive women, who were infected with HPV, had a significantly more probability to have a single partner in their lifetime than those who were not infected. It could be that HPV cervical infection and HIV-seropositive women share common potential risk factors, as well as, the recognition of sexual intercourse as the important route of HPV transmission.

Collection and processing of umbilical cord blood for cryopreservation.

Umbilical cord blood (UCB) is being increasingly used as an alternative source of hematopoietic stem cells for allogeneic bone marrow transplantation. UCB transplantation has been successfully used to treat a variety of genetic, hematological, and oncological disorders in children and adults. The objectives of this study was to establish a closed-system technique for UCB collection and buffy coat separation by Optipress I device. Thirty-four UCB were collected by triple-bag system from pregnant mothers whose fetuses were not affected by thalassemic diseases after prenatal diagnosis. The mean volumn of UCB collection were 120 +/- 5 ml (range 65-180 ml). Total WBC, CD34+ cells, the progenitor cell erythroid burst-forming unit (BFU-E) and granulocyte-macrophage colony-forming unit (CFU-GM) in the UCB units were (9.36 +/- 0.84) x 10(8), (3.61 +/- 0.52) x 10(6), (9.12 +/- 1.60) x 10(5), and (5.32 +/- 1.23) x 10(5), respectively. Good correlation between the nucleated cell and net cord blood volume could be demonstrated (p < 0.0001). The correlation between CD34+ cells and the following parameters: nucleated cell, BFU-E or CFU-GM were also demonstrated (p = 0.001, 0.0105 or 0.0001, respectively). Buffy coat was subsequently separated from 18 UCB units by Optipress I device. 70 +/- 3 ml of buffy coat were collected and cryoprocessing was done by automatic controlled-rate freezer. Good recovery of total WBC, CD34+ cells, progenitor cells BFU-E and CFU-GM after buffy coat separation were observed 89 per cent, 95 per cent, 109 per cent, and 102 per cent respectively. There was no aerobic bacterial or fungal contamination in the separated blood products. By using this technique, the UCB units were easily collected, rapidly separated within one hour, and high recovery of the hematopoietic progenitor cells could be obtained.

Relationship between human papilloma virus infection and abnormal Pap smear in HIV-seropositive women at Siriraj Hospital.

The purpose of this prospective study was to determine the prevalence of human papillomavirus and abnormal Pap smear in HIV-seropositive women, particularly in HIV-seropositive women who undertook antiretroviral drug. The consecutive series of 178 HIV-seropositive women was enrolled in the Department of Obstetrics and Gynecology, Siriraj Hospital. All general information and laboratory results of the patients were recorded. Pap smears are obtained from the endocervix, cervical transformation zone and vagina by using a cotton tip stick and Ayre spatula, as described in the VCE technique. The patients were assigned into two groups, the AZT and non-AZT group. The comparison between the groups was calculated statistically. It was found that 88 of 178 HIV-seropositive women (49.4%) undertook Zidovudine. The prevalence of abnormal Pap smear in HIV-seropositive women, who had an abnormal Pap smear, was 59.6 per cent. However, the prevalence of human papillomavirus infection detected by Pap smear was reported in 17 patients (9.6%). There was no difference between the AZT and non-AZT group statistically. There was a significantly higher probability of finding an abnormal Pap smear for cervical dysplasia in HIV-seropositive women who were infected with human papillomavirus compared to. It is concluded that there is a higher risk of developing cervical dysplasia in HIV-seropositive women who carry the human papillomavirus.

Morbidity and mortality from birth before arrival at Siriraj Hospital.

OBJECTIVE: To identify maternal and infant morbidity and mortality from birth before arrival at Siriraj Hospital. STUDY DESIGN: Prospective case-control study. Setting: Department of Obstetrics & Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University. SUBJECTS: Three hundred and twenty patients, who had delivered at Siriraj Hospital, were divided into two groups. The study group consisted of 160 patients, who gave birth before admission to the labour room of Siriraj Hospital. The control group consisted of 160 patients, who had normal deliveries in the labour room of Siriraj Hospital at the same period of time. INTERVENTION: Interviewing the patients and reviewing the medical records of the mothers and infants from both groups. The data were analyzed by using the EpiInfo program. MAIN OUTCOME MEASURE: Maternal and infant characteristics after delivery, maternal and infant outcomes including puerperal morbidity, low birth weight, perinatal death and infant morbidity. RESULTS: The study showed that the mothers in the study group had to stay in the hospital longer than the control group (3.9 +/- 2.5 days and 3.6 +/- 1.3 days respectively, p < 0.05). The infants in the study group also had to stay in the hospital longer than the control group (5.1. +/- 6.5 days and 3.3 +/- 1.7 days respectively, p < 0.001). The birth weights of infants in the study group were significantly lower than in the control group (2,753.4 +/- 594.1 grams and 3,016.6 +/- 405.0. grams respectively, p < 0.001). The body temperature of the newborns in the study group were also lower than in the control group (36.2 +/- 0.6 degree Celsius and 37.0 +/- 0.4 degree Celsius respectively, p < 0.05). Concerning maternal and infant outcomes, all variables including low birth weight,perinatal death and infant morbidity were better in the control group significantly (p < 0.05) except for puerperal morbidity that had no significant difference (p = 0.77). CONCLUSION: From the present study, the authors confirmed the higher mortality and morbidity rate of infants who were born unexpectedly before hospital admission. However, there was no difference in morbidity between the mothers of both groups.

Risk factors for birth before arrival at Siriraj Hospital.

OBJECTIVE: To assess the potential risk factors for birth before arrival at Siriraj Hospital. STUDY DESIGN: Prospective case-control study. SETTING: Department of Obstetrics & Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University. SUBJECTS: The subjects were 320 patients who had delivered at Siriraj Hospital and were divided into two groups. One hundred and sixty patients, who gave birth before admission to the labor room of Siriraj Hospital, were assigned as the study group. The control group consisted of 160 patients who had normal deliveries in the labor room of Siriraj Hospital at the same period of time. INTERVENTION: Information was obtained by interviewing the patients. Both the interviewer and the subjects were blinded to each other. The data were analyzed by using logistic regression model and EpiInfo program. MAIN OUTCOME MEASURE: Information of antenatal care, socio-economic data, past obstetric history and present data of delivery. RESULTS: The six significant risk factors were identified; education level of the patients (odds ratio 6.11), past history of previous delivery (odds ratio 6.18), past history of preterm delivery (odds ratio 4.03), no antenatal care (odds ratio 8.55), unawareness of true labor symptoms (odds ratio 1.89) and present preterm delivery (odds ratio 2.99). CONCLUSION: The risk factors identified from this study were low education level, past history of previous delivery, past history of preterm delivery, no antenatal care, unawareness of symptoms of true labor and present preterm delivery. The risk factors from this study should have further study to get more information that can apply to control birth before arrival.

Rapid human immunodeficiency virus diagnostic test during the intrapartum period in pregnant women who did not receive antenatal care.

The main barrier to implementation of antiretroviral drugs in HIV-infected pregnant women is the lack of antenatal care (ANC). From April 1999 to December 2001, the prevalence of pregnant women not receiving ANC and coming for delivery in Siriraj Hospital was 7.3 per cent (2,152/29,484) and the prevalence of HIV infection among this group was 5.7 per cent, substantially higher than that of 27,332 pregnant women receiving ANC in Siriraj Hospital (2.2%). Besides developing interventions to increase use of ANC, the test for diagnosis of HIV infection during the intrapartum period should be rapid, inexpensive, highly sensitive and specific, easy to perform and results should be easy to interpret. The Determine Rapid Test for detection of HIV fulfills these criteria with 100 per cent sensitivity, 99.85 per cent specificity, 97.54 per cent positive predictive value, 100 per cent negative predictive value and 0.14 per cent false positive. To improve prevention of mother-to-child HIV transmission (PMTCT), the authors believe that this uncomplicated rapid HIV testing should be used during the intrapartum period to Thai-pregnant women who did not receive antenatal care and antiretroviral drugs might be offered as soon as possible for those testing HIV-positive and for their baby as chemoprophylaxis.

Misoprostal use for therapeutic abortion in Siriraj Hospital: the year 2000.

OBJECTIVE: To evaluate the efficacy and the adverse effects of misoprostal usage for therapeutic abortion in Siriraj Hospital. STUDY DESIGN: Cross-sectional, descriptive study. MATERIAL AND METHOD: A consecutive series of 101 therapeutic abortions was performed in the Department of Obstetrics & Gynecology, Siriraj Hospital in the year 2000. The patients were interviewed for general information and registered, as well as in-patient data. Any adverse events were recorded and collected from the inpatient record file. All data were analyzed statistically. RESULTS: 42 therapeutic abortions were conducted in association with misoprostal usage. Misoprostal was used for cervical ripening in 8 patients with a good outcome. 31 therapeutic abortions were induced by misoprostal alone regimen. A higher success rate (74.1%) was correlated with higher gestational age. 27 out of 31 cases were second trimester abortion. The induction to abortion interval was 18.0+/-10.5 hours (range 5-48). No factor, including age, weight, total dose of misoprostal use, nulliparity and viability of the fetus, could be demonstrated to affect the misoprostal activity defined by induction to abortion interval. There was no serious adverse event, except for severe abdominal cramping (26.2%) and fever (14.3%). CONCLUSION: Misoprostal alone can be used with caution for abortion induction especially in second trimester abortion.

Maternal death in Siriraj Hospital: A 25-year review.

The medical record of 465,086 deliveries at Siriraj Hospital between the years 1974-1999 were analyzed in order to estimate the maternal mortality ratio and to identify the types and causes of maternal death. There were a total of 137 maternal deaths. The overall mortality ratio for the period was 29.61 per 100,000 live births. The maternal mortality ratio showed a downward trend year by year but has remained rather stable over the last 15 years. Direct maternal death, 73.72%, was the most common cause of maternal death followed by indirect maternal death (20.44%) and non maternal death (5.84%) respectively. Obstetric infection was the most common causes of direct maternal death while cardiac disease was the most common cause of indirect maternal death. Non maternal death did not play significant role in maternal mortality since it contributed a very small proportion and was mostly due to malignancy at various sites. Increasing maternal age showed a correlation with an increasing maternal mortality ratio while maternal parity showed a different pattern. The findings of this study will help us to plan policies to reduce the maternal mortality ratio in the future.

Accuracy of leopold maneuvers in screening for malpresentation in pregnant women at term.

From December 1996 to February 1997 a total of 310 pregnant women at term who attended antenatal care clinic at Siriraj Hospital underwent abdominal examination using Leopold maneuvers by the first year resident physicians on duty. Then they were reexamined using ultrasonography by the staff physicians in ultrasound clinic without prior knowledge of the results of previous abdominal examinations. Compared with the ultrasonographic results, the accuracy, sensitivity, specificity, positive predictive value, negative predictive value, false positive rate and false negative rate of Leopold maneuvers in screening for malpresentation in pregnant women at term were 96.8, 66.7, 98.3, 66.7, 98.3, 1.6 and 1.6 percent respectively. The use of Leopold maneuvers for diagnosis of malpresentation has limit sensitivity. However, it is appreciably specific for diagnosis of normal fetal presentation. In conclusion, all cases of fetal malpresentation diagnosed by Leopold maneuvers should be further examined by other methods for specific diagnosis.

Elongation of the uterine cervix: A case report.

Pelvic organ prolapse, a disorder of pelvic support, usually occurs in elderly multiparous women. Some manifestations such as cervical elongation are quite uncommon. We report here on a 24 a year a old woman, who presented with a history of two prior consecutive abortions and a problem with a vaginal mass. Pelvic examination and hysterosalpingography revealed an elongated cervix. A Manches-ter operation was performed. After treatment, there were no acute complications, but observations for long term sequelae and the potential effects on fertility must be continued.

The efficiency of low dose combined oral contraceptives for postponement of menstruation in Thais.

A randomized double blind clinical trial was carried out at the Division of Family Planning, Siriraj Hospital in order to study the efficiency of low dose oral contraceptive pills, containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestel, for postponement of menstruation. Sixty hralthy women with previous regular menstruation were randomly assigned to one of two study groups. Thirty women in the control group received 10 capsules of a placebo and the other 30 women in the study group received 10 capsules that contained the oral contraceptives. The women in both groups began taking the in doses of one capsule per day for three days before the expected date of menstruation. The characteristics of both groups were comparable. The number of women who expected postponement of their menstruation were recorded together with the side-effects. The results showed that oral contraceptive pills taken three days before the expected date of menstruation could postpone menstruation significantly (27/30 vs 2/30, p< 0.05). The major side-effects were headache (10 percent) and nausea (13.3 percent).

Comparison of pain during postpartum tubal sterilization between patient premedicated with intramuscular morphine and sublingual buprenorphine.

A randomized double blind clinical trial was carried out at Siriraj Hospital in order to compare pain level during postpartum tubal sterilization between patient premedicated with intramuscular morphine and sublingual buprenorphine. Eighty postpartum women were randomly assigned to one of the two studied groups. The first group was premedicated with intramuscular morphine and oral placebo, the other received sublingual buprenorphine and intramuscular tetanus toxoid. Recorded pain level in abdominal cavity at 5 minutes before drug administration, 30 minutes after drug administration and immediately after surgery. AII side effects were observed, recorded and compared between two groups. There were no significant differences between two groups in the pain relief in postpartum tubal sterilization. Major side effects are nuasea, vomiting and dizziness. Sublingual buprenorphine can be used as a premedication in a normal postpartum women who plan to receive postpartum tubal sterilization instead of intramuscular morphine.

Bupivacaine plus fentanyl for intrapartum continuous epidural analgesia.

Labour pain relief using 0.125% bupivacaine plus fentanyl for intrapartum continuous epidural analgesia and intravenous pethidine plus phenergan were evaluated by randomized clinical trial in 40 patients seen at the labour room of Siriraj Hospital. The progression of labour, pain levels at 15 minutes before and after drug administration and in the second stage, the method of delivery and all side effects within two groups were observed and compared. From the study, it was found that continuous epidural analgesia with the new drug combination was more effective in relieving labour. There was no significant difference in the progression of labour and the frequency of instrumental delivery. The main side effects of nausea, vomiting and somnolence were observed to be less in the study group less than other patient but one parturient was found to have developed hypotension.

Ovarian tumors in children and adolescents: A review of 52 cases.

This retrospective study reports on 52 cases of ovarian tumors in young females (under 20 years) treated at Siriraj Hospital over a five-year period from 1988 to 1992. The incidence was 4.7 percent of all ovarian tumors (1,103 cases). Of the total, 41 cases were benign, 10 were malignant and one was a borderlined tumor. In 31 cases (59.6 percent) germ cell tumors were found, of which 19.4 percent were malignant. The common presenting symptom was either abdominal mass (53.9 percent) or abdominal pain (26.9 percent). The tumors, which developed in more than half of the patients (57.7 percent), were between 6 and 15 cm in greatest diameter. Bilaterality was found in five patients (9.6 percent) and six (11.5 percent) and torsion of the tumor. Surgical treatment was conservative in 86.5 percent and radical in 13.5 percent of the patients.