Oral Tetrahydrocannabinol (THC):Cannabinoid (CBD) Cannabis Extract Adjuvant for Reducing Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial.

Objective: To evaluate the effects of tetrahydrocannabinol (THC):cannabinoid (CBD) (1:1) oil in reducing chemotherapy-induced nausea and vomiting (CINV) in gynecologic cancer patients who received moderate-to-high emetogenic chemotherapy. Material and Method: This was a randomized, double-blinded, crossover and placebo-controlled trial. The study was conducted at the Gynecologic Oncology Units, Bhumibol Adulyadej Hospital (BAH), Royal Thai Air Force, Bangkok, Thailand, between August and November 2022. Participants had gynecologic cancer and received moderate-to-high emetogenic chemotherapy. Subjects were randomized and divided into two groups (A and B) based on the block of four randomization method. In the first cycle, groups A and B received THC:CBD extract oil 1:1 (TCEO) and placebo before chemotherapy administration. In the second cycle, groups A and B received placebo and TCEO before chemotherapy administration. Both groups received per protocol antiemetic medication during chemotherapy. Nausea score and side effects were recorded. Results: A total of 60 cases were recruited. After exclusion, 54 cases were included in the study. The mean age of participants was 54.4 years. The mean body mass index (BMI) was 26.5 kg/m2. Fifty-nine (21/54) percent cases were the advanced stages of cancer. The nausea score of TCEO and placebo groups were 2.11 and 2.99, respectively (P < 0.05). More than half of the participants (36/54) reported dizziness and sedation side effects. Dry mouth, confusion, anxiety, and palpitation of both groups were comparable. Conclusion: The cannabinoid extract (THC:CBD) was an appropriate adjuvant agent to reduce CINV in patients with gynecologic cancer who received high-emetogenic chemotherapy. Dizziness and sedation were the major side effects.

Endometrial Thickness Measurement as Predictor of Endometrial Hyperplasia and Cancer in Perimenopausal Uterine Bleeding: Cross-Sectional Study.

BACKGROUND: Endometrial thickness (ET) measurement was an alternative method for predicting abnormal endometrial pathology in postmenopausal bleeding. Cut-off value of ET measurement could not be use in perimenopausal bleeding. OBJECTIVE: Aim of this study was to investigate appropriate ET cut-off value for perimenopause women with abnormal uterine bleeding (PEMB) and abnormal endometrial histopathology. MATERIAL AND METHODS: This was a cross-sectional study. PEMB at Bhumibol Adulyadej Hospital between July 2018 and June 2022 were recruited. Subjects who met inclusion criteria underwent ET measurement and endometrial biopsy via endometrial aspirator. Participants who had histopathology report of endometrial hyperplasia and more were classified as the study group. The Control group were subjects with no endometrial hyperplasia or cancer. Demographic and clinical character data were included. Correlation of ET and endometrial histopathology were calculated for statistical significance. RESULTS: A total of 304 cases were included. After exclusion, 254 subjects were recruited for this study. There were 22 and 232 cases in the study and control groups, respectively. The mean age and body mass index (BMI) of participants were 44.7 years old and 27.5 kg/m2, respectively. Prevalence of endometrial hyperplasia and cancer in perimenopausal uterine bleeding were 7.5 (19/254) and 1.2 (3/254) percent, respectively. Endometrial thickness equal to and more than 8 mm was associated with abnormal endometrial histopathology with statistical significance. Age, BMI, nulliparity, anovulatory bleeding history, hypothyroidism, diabetes mellitus and anovulation state of both groups were comparable. CONCLUSIONS: Endometrial thickness equal or more than 8 mm were significantly associated with endometrial hyperplasia or more among perimenopausal women with abnormal uterine bleeding.

Sublingual Misoprostol versus Oxytocin to Induce Labor in Term Premature Rupture of Membranes in Pregnant Women: A Randomized Single-Blind Controlled Trial.

OBJECTIVE: The aim of this study was to compare maternal and neonatal outcomes between sublingual misoprostol and oxytocin on stimulating labor in term premature rupture of membranes (PROM) in pregnant women. Materials and method. This randomized single-blind control trial was conducted at Bhumibol Adulyadej Hospital (BAH), Royal Thai Air Force, Bangkok, Thailand, between September 2020 and February 2021. Subjects were term pregnant women who had PROM and came to BAH for delivery. Participants were allocated into study (misoprostol) and control (oxytocin) groups. The study and control groups were, respectively, administered sublingual misoprostol and intravenous oxytocin to induce labor. Induction time and second stage of labor were recorded. Neonatal outcomes and maternal and fetal complications were also recorded and analyzed. RESULT: A total of 170 women were enrolled and equally divided into study and control groups. Mean maternal age, body mass index, parity, gestational age, and bishop score of both groups were comparable. Induction time of the study group was statistically shorter than the control group (338 and 399 min, respectively). Duration of active phase (450/427 min) and the second stage (19/21 min) of labor between study and control groups were not significantly different. Cesarean section delivery rate of study was lower than the control group (13.3 and 28.8%, p = 0.002). Intrapartum complications, neonatal outcomes, and intra- and postpartum complications among both groups were not significantly differentiated. There was no instance of postpartum hemorrhage or uterine rupture in the present study. CONCLUSION: Induction time and cesarean section rates of sublingual misoprostol group were significantly lower than the intravenous oxytocin group in full-term PROM pregnancy.

Proximal tubular dysfunction in pregnant women receiving tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus.

BACKGROUND: Data evaluating the risk of proximal tubular dysfunction in women receiving tenofovir disoproxil fumarate for the prevention of mother-to-child transmission (PMTCT) of HBV are scarce. OBJECTIVES: To assess the risk of proximal tubulopathy in pregnant women receiving tenofovir disoproxil fumarate for PMTCT of HBV. PATIENTS AND METHODS: We used urine samples collected from HBV monoinfected pregnant women who participated in a Phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial assessing a tenofovir disoproxil fumarate short course from 28 weeks gestational age (28-wk-GA) to 2 months post-partum (2-months-PP) for PMTCT of HBV in Thailand. Markers of tubular dysfunction, including retinol binding protein, kidney injury molecule-1, α1-microglobuin and ß2-microglobulin, were assayed at 28- and 32-wk-GA and 2-months-PP visits. Proximal tubulopathy was defined as the presence of ≥2 of the following: tubular proteinuria, euglycaemic glycosuria and increased urinary phosphate. RESULTS: A total of 291 women participated in the study. No kidney-related adverse events were severe, and none led to tenofovir disoproxil fumarate discontinuation. At 2-months-PP, 3 of the 120 (3%) evaluated women in the tenofovir disoproxil fumarate group experienced proximal tubulopathy versus 3 of 125 (2%) in the placebo group (P = 1.00). None of the six women met the criteria for proximal tubulopathy at 12-months-PP but proteinuria persisted in three of them. No growth abnormalities were found at 1 year of age in infants born to mothers with proximal tubulopathy at 2-months-PP. CONCLUSIONS: In these HBV-infected pregnant and breastfeeding women, tenofovir disoproxil fumarate administered from 28-wk-GA to 2-months-PP was not associated with a higher risk of proximal tubulopathy.

Nomogram of fetal right portal vein diameter at gestational age 30 to 35 weeks and prediction of small for gestational age at birth.

AIM: To construct the nomogram of fetal right portal vein (RPV) diameter at 30 to 35 weeks' gestation in Thai pregnant population and the use of RPV measurement to predicting small for gestational age (SGA) fetus. METHODS: A prospective, cross-sectional study of singleton pregnancies at antenatal visit between 30 and 35+6 weeks of gestation in single center, Bhumibol Adulyadej Hospital (BAH) was conducted from January to August 2020. Ultrasonography of fetal biometry and RPV diameter measurement were performed as well as immediate newborn birth weight measurement. The nomogram of fetal RPV was developed for standardization for Thai people. RESULTS: A total of 219 singleton pregnant women were enrolled and ultrasonographic measurement of RPV and fetal biometry was obtained. Mean maternal age and gestational period were 29.4 years and 33.0 weeks, respectively. One third of participants were classified as obese. RPV diameter ranged from 1.85 to 6.07 mm and increased linearly with gestational age. The optimal threshold of RPV diameter for diagnosis SGA was less than 3.06 mm with area under ROC curve at a level of 0.613 (95%CI 0.496 to 0.731). Sensitivity and specificity were 38.46% and 83.94%, respectively. There was no fetal death or neonatal morbidity in the present study. CONCLUSION: RPV diameter increases in size depending on gestational age. RPV diameter at 30 to 35+6 weeks gestation was a useful measurement for SGA prediction. RPV measurements greater than 3.06 mm strongly indicated normal fetal growth.

Maternal and Neonatal Complications of Methamphetamine Use during Pregnancy.

BACKGROUND: Methamphetamine abuse has been a significant problem in Thailand. The methamphetamine abuse problem also affects pregnant women. The study of pregnancy outcomes among methamphetamine users during pregnancy is currently limited. OBJECTIVE: To determine maternal and neonatal complications among methamphetamine-abusing parturients. Materials and method. This historical cohort study was conducted at Bhumibol Adulyadej Hospital (BAH), Bangkok, Thailand, between January 2017 and December 2019. The total number of women was 206 who were equally divided into a study and control group. Pregnant women who tested positive for methamphetamine in urine tests during the intrapartum period were compared to the control group with no history of drug abuse. RESULTS: Maternal outcomes: gestational hypertension was found to be significantly increased in the study group compared to the control group at 14.6 vs. 1.0% (OR 17.4, 95%CI 2.5-134.3). Preeclampsia with and without severe features were found at higher rates in the study group without statistical significance. There were no eclamptic cases in this study. Neonatal outcomes: preterm birth rate of pregnant women who have tested positive in their urine methamphetamine test was significantly higher than in the control group (33.3%, 11.7%, OR 3.7, 95%CI 1.8-7.7). Average birth weight in the study and control group was 2779.1 ± 486.7 and 3049.5 ± 510 gm, respectively (p value < 0.001). Low APGAR score rates of both groups also had no significant difference. CONCLUSION: Methamphetamine use during pregnancy increased both maternal and neonatal complications in terms of gestational hypertension, preterm birth, and average birth weight.

Recurrence Rate and Risk Factors for the Recurrence of Ovarian Endometriosis after Laparoscopic Ovarian Cystectomy.

The aim of this study was to identify the recurrence rate and risk factors for the recurrence of ovarian endometriosis (OE) after laparoscopic cystectomy. This was a retrospective cross-sectional study. Subjects were OE cases who underwent laparoscopic ovarian cystectomy at Bhumibol Adulyadej Hospital (BAH). The period of this study was from January 2008 to December 2017. Ovarian histopathology and at least one-year follow-up after surgery were the prerequisite requirements. A total of 106 OE cases were included in the study. Subjects were classified into recurrence and nonrecurrence groups. It comprised of 24 and 82 cases, respectively. The mean age of the participant was 32.4 years old. The demographic characters of both groups were comparable. The recurrence rate after laparoscopic OE surgery in the present study was 22.6% (24/106). The average largest diameter of OE in the present study was 54.5 mm. Postoperative medical treatment (OR 3.15, 95% CI 1.14-8.74, p = 0.02) and postoperative pregnancy (OR 2.86, 95% CI 1.03-7.93, p = 0.04) were associated factors for recurrence decrement. The recurrence rate of OE after laparoscopic cystectomy was 22.6%. Postoperative medical treatment and postoperative pregnancy were a significant factor that lowered OE recurrence.

Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.

BACKGROUND: Although antiretroviral regimens containing integrase inhibitors rapidly suppress HIV viral load in non-pregnant adults, few published data from randomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavirenz when initiated during pregnancy. We compared safety and efficacy of antiretroviral therapy with either raltegravir or efavirenz in late pregnancy. METHODS: An open-label, randomised controlled trial was done at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV were assigned to antiretroviral regimens containing either raltegravir (400 mg twice daily) or efavirenz (600 mg each night) plus lamivudine 150 mg and zidovudine 300 mg twice daily (or approved alternative backbone regimen), using a web-based, permuted-block randomisation stratified by gestational age and backbone regimen. The primary efficacy outcome was plasma HIV viral load below 200 copies per mL at (or near) delivery. The primary efficacy analysis included all women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria. The primary safety analyses included all women who received study drug, and their infants. This trial is registered with Clinicaltrials.gov, number NCT01618305. FINDINGS: From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz). 144 (94%) women in the raltegravir group and 129 (84%) in the efavirenz group met the primary efficacy outcome (absolute difference 10%, 95% CI 3-18; p=0·0015); the difference primarily occurred among women enrolling later in pregnancy (interaction p=0·040). Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. INTERPRETATION: Our findings support major guidelines. The integrase inhibitor dolutegravir is currently a preferred regimen for the prevention of perinatal HIV transmission with raltegravir recommended as a preferred or alternative integrase inhibitor for pregnant women living with HIV. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases.

The Evaluation of Intra-Operative Frozen Section Diagnosis Accuracy of Ovarian Tumors; Old Fashioned Not Out of Fashion.

BACKGROUND: The accuracy of intra-operative decision in confirming ovarian tumor malignancy during the operation is vital. Frozen sections are an important intra-operative tool to determine the provisional diagnosis and appropriate treatment of a tumor. STUDY DESIGN: All records of diagnosed ovarian tumor patients who underwent exploratory laparotomy with intra-operative frozen sections request at Bhumibol Adulyadej Hospital (BAH) between January 2016 and June 2018 were reviewed. MAIN OUTCOME MEASURES: Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of intra-operative frozen and permanent sections were evaluated. RESULT: A total of 150 cases were recruited in this study. The mean age was 45.4 years. The number of benign, borderline and malignant ovarian tumors in this study were 97, 9 and 44 cases, respectively. The overall accuracy was 93.3%. Percentage of accuracy, sensitivity, specificity, PPV and NPV for benign, borderline and malignancy were 98.0/94.7/94.0, 100/88.9/79.6, 94.3/95.0/100, 97.0/55.3/100 and 100/99.3/92.2, respectively. CONCLUSION: The frozen section results yielded accurate diagnosis for rapid intraoperative evaluation of ovarian tumors. Its high accuracy allows for an appropriate surgical plan to be made in a timely manner. Large sizes and suspected mucinous borderline ovarian tumors reduced accuracy factors of frozen sections.

Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B.

BACKGROUND: Pregnant women with an elevated viral load of hepatitis B virus (HBV) have a risk of transmitting infection to their infants, despite the infants' receiving hepatitis B immune globulin. METHODS: In this multicenter, double-blind clinical trial performed in Thailand, we randomly assigned hepatitis B e antigen (HBeAg)-positive pregnant women with an alanine aminotransferase level of 60 IU or less per liter to receive tenofovir disoproxil fumarate (TDF) or placebo from 28 weeks of gestation to 2 months post partum. Infants received hepatitis B immune globulin at birth and hepatitis B vaccine at birth and at 1, 2, 4, and 6 months. The primary end point was a hepatitis B surface antigen (HBsAg)-positive status in the infant, confirmed by the HBV DNA level at 6 months of age. We calculated that a sample of 328 women would provide the trial with 90% power to detect a difference of at least 9 percentage points in the transmission rate (expected rate, 3% in the TDF group vs. 12% in the placebo group). RESULTS: From January 2013 to August 2015, we enrolled 331 women; 168 women were randomly assigned to the TDF group and 163 to the placebo group. At enrollment, the median gestational age was 28.3 weeks, and the median HBV DNA level was 8.0 log10 IU per milliliter. Among 322 deliveries (97% of the participants), there were 319 singleton births, two twin pairs, and one stillborn infant. The median time from birth to administration of hepatitis B immune globulin was 1.3 hours, and the median time from birth to administration of hepatitis B vaccine was 1.2 hours. In the primary analysis, none of the 147 infants (0%; 95% confidence interval [CI], 0 to 2) in the TDF group were infected, as compared with 3 of 147 (2%; 95% CI, 0 to 6) in the placebo group (P=0.12). The rate of adverse events did not differ significantly between groups. The incidence of a maternal alanine aminotransferase level of more than 300 IU per liter after discontinuation of the trial regimen was 6% in the TDF group and 3% in the placebo group (P=0.29). CONCLUSIONS: In a setting in which the rate of mother-to-child HBV transmission was low with the administration of hepatitis B immune globulin and hepatitis B vaccine in infants born to HBeAg-positive mothers, the additional maternal use of TDF did not result in a significantly lower rate of transmission. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT01745822 .).

Reduced indinavir exposure during pregnancy.

AIM: To describe the pharmacokinetics and safety of indinavir boosted with ritonavir (IDV/r) during the second and third trimesters of pregnancy and in the post-partum period. METHODS: IMPAACT P1026s is an on-going, prospective, non-blinded study of antiretroviral pharmacokinetics (PK) in HIV-infected pregnant women with a Thai cohort receiving IDV/r 400/100 mg twice daily during pregnancy through to 6-12 weeks post-partum as part of clinical care. Steady-state PK profiles were performed during the second (optional) and third trimesters and at 6-12 weeks post-partum. PK targets were the estimated 10(th) percentile IDV AUC (12.9 µg ml(-1)h) in non-pregnant historical Thai adults and a trough concentration of 0.1 µg ml(-1), the suggested minimum target. RESULTS: Twenty-six pregnant women were enrolled; thirteen entered during the second trimester. Median (range) age was 29.8 (18.9-40.8) years and weight 60.5 (50.0-85.0) kg at the third trimester PK visit. The 90% confidence limits for the geometric mean ratio of the indinavir AUC(0,12 h) and Cmax during the second trimester and post-partum (ante : post ratios) were 0.58 (0.49, 0.68) and 0.73 (0.59, 0.91), respectively; third trimester/post-partum AUC(0,12 h) and Cmax ratios were 0.60 (0.53, 0.68) and 0.63 (0.55, 0.72), respectively. IDV/r was well tolerated and 21/26 women had a HIV-1 viral load < 40 copies ml(-1) at delivery. All 26 infants were confirmed HIV negative. CONCLUSION: Indinavir exposure during the second and third trimesters was significantly reduced compared with post-partum and ∼30% of women failed to achieve a target trough concentration. Increasing the dose of IDV/r during pregnancy to 600/100 mg twice daily may be preferable to ensure adequate drug concentrations.

A comparison of 3 regimens to prevent nevirapine resistance mutations in HIV-infected pregnant women receiving a single intrapartum dose of nevirapine.

BACKGROUND: Intrapartum single-dose (SD) nevirapine (NVP) reduces perinatal transmission of human immunodeficiency virus (HIV) infection but selects for NVP-resistant virus, which compromises subsequent NVP-based therapy. A 1-week "tail" of lamivudine and zidovudine after SD-NVP decreases the risk of resistance. We hypothesized that increasing the duration or potency of the tail would further reduce this risk to <10%, using a sensitive assay to measure resistance. METHODS: HIV-infected pregnant Thai women with a CD4 cell count >250 cells/µL, most receiving zidovudine, were randomized at 28-38 weeks gestation to receive 1 of 3 intrapartum and postpartum regimens: (A) zidovudine plus enteric-coated didanosine plus lopinavir and ritonavir for 7 days, (B) zidovudine plus enteric-coated didanosine for 30 days, or (C) regimen 1 for 30 days. The incidence of NVP resistance mutations at day 10 or week 6 post partum in each arm was compared with that of a historical comparison group who received prenatal zidovudine and SD-NVP. NVP resistance was identified by consensus sequencing and a sensitive oligonucleotide ligation assay (OLA). RESULTS: At entry, the 169 participants had a median CD4 cell count of 456 cells/µL and an HIV load of 3.49 log(10) copies/mL. The incidence of mutations in each of the 3 P1032 arms was 0% by sequencing and 1.8%, 7.1%, and 5.3% by OLA in arms A, B, and C, respectively, compared with 13.4% by sequencing and 29.4% by OLA in the comparison group (P < .001 for each study arm vs comparison group). Grade 4 anemia developed in 1 woman. CONCLUSIONS: A 7-day tail of highly active combination therapy or 1 month of dual therapy after SD-NVP prevents most NVP resistance to minimal toxicity. CLINICAL TRIALS REGISTRATION: The IMPAACT P1032 Clinical Trial is NCT00109590, and the PHPT-2 Clinical Trial is NCT00398684.

Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum.

BACKGROUND: The impact of pregnancy on efavirenz (EFV) pharmacokinetics is unknown. METHODS: International Maternal Pediatric Adolescent AIDS Clinical Trials P1026s is an on-going, prospective, nonblinded study of antiretroviral pharmacokinetics in HIV-infected pregnant women that included a cohort receiving 600 mg EFV once daily as part of combination antiretroviral therapy. Intensive steady-state 24-hour blood sampling was performed during the third trimester and at 6-12 weeks postpartum. Maternal and umbilical cord blood samples were drawn at delivery. Pharmacokinetics targets were the estimated 10th percentile EFV area under the curve (AUC) in nonpregnant historical controls (40.0 mcg·hr(-1)·mL(-1)) and a trough concentration of 1 mcg/mL. RESULTS: Twenty-five women were enrolled during the third trimester: median (range) age was 29.3 (18.9-42.9) years, weight 69.0 (40-130) kg, and gestational age 32.9 (30.1-38.7) weeks. Median (range) EFV AUC(0-24), C(max), and C(24 hours) were 55.4 mcg·hr(-1)·mL(-1) (13.5-220.3), 5.4 mcg/mL (1.9-12.2), and 1.6 mcg/mL (0.23-8.13), respectively. EFV AUC and C(max) did not differ during pregnancy and postpartum but C(24 hours) was lower during the third trimester (1.6 vs. 2.1 mcg/mL, P = 0.01). During the third trimester, 5 of 25 (20%) women had an EFV AUC below the target and 3 of 25 (12%) had a trough concentration below 1 mcg/mL. EFV cord blood/maternal concentration ratio was 0.49 (0.37-0.74). All women had a HIV-1 RNA viral load less than 400 copies per milliliter at delivery and 19 (76%) had a viral load below 50 copies per milliliter. One child was perinatally HIV infected. Three women were exposed to EFV throughout the first 6 weeks of pregnancy. EFV was well tolerated, and among the 25 infants, no congenital anomalies or newborn complications were reported. CONCLUSIONS: Changes in EFV pharmacokinetics during pregnancy compared with postpartum are not sufficiently large enough to warrant a dose adjustment during pregnancy.

Is it time for routine ultrasound in late pregnancy at Bhumibol Adulyadej Hospital?

BACKGROUND: At term, about 3-5% of the presentations are breech. Vaginal breech deliveries are associated with increased maternal and fetal morbidity and mortality, but delivery by cesarean section in an emergency does not eliminate all maternal and perinatal morbidity. The use of external cephalic version can produce considerable cost savings in the management of the breech fetus at term. The accuracy in the assessment of fetal presentation and position is essential. OBJECTIVE: To study the accuracy of Leopold's maneuvers in the assessment of fetal presentation and position at Bhumibol Adulyadej Hospital. MATERIAL AND METHOD: Prospective cohort study of 1,528 singletons, pregnant women at gestational age between 34-40 weeks who attended antenatal care unit at Bhumibol Adulyadej Hospital between November 1, 2006 and March 30, 2009. All cases were examined by either residents or staff by using Leopold's maneuvers. The results of the examinations were recorded as cephalic or non-cephalic presentation. After that, the subjects were re-examined by the staff in the maternal and fetal medicine unit using ultrasound for gold standard. Maternal age, weight, height, gestational age, parity, estimated fetal weight, amniotic fluid index, placental site, and fetal presentation were recorded. The results of the two methods of examination were then analyzed for comparison and calculated in terms of means, standard deviation, sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. RESULTS: The results of Leopold's maneuvers with 95% confidence interval revealed sensitivity 63.17 +/- 10.84%, specificity 93.35 +/- 1.25%, positive predictive value 34.04 +/- 7.82%, negative predictive value 97.98 + 0.74%, and accuracy 92.08 +/- 1.35%. CONCLUSION: Leopold's maneuvers are inexpensive, easy to perform, and noninvasive but the accuracy of such assessments vary depending on many factors especially experience of operators. The caregivers can reduce perinatal morbidity and mortality if they can diagnose all of non-vertex presentation in near term pregnancy. Routine use of ultrasound in near term pregnancy to diagnose non-vertex presentation has more benefit than cost.

Early postpartum pharmacokinetics of lopinavir initiated intrapartum in Thai women.

Lopinavir (LPV) exposure is reduced during the third trimester of pregnancy. We report the pharmacokinetics of standard LPV-ritonavir dosing (400/100 mg twice daily) in the immediate and early postpartum period when initiated during labor. In 16 human immunodeficiency virus-infected Thai women, the median (range) LPV area under the concentration-time curve and maximum and minimum concentrations in plasma were 99.7 (66.1 to 180.5) microg x h/ml, 11.2 (8.0 to 17.5) microg/ml, and 4.6 (1.7 to 12.5) microg/ml, respectively, at 41 (12 to 74) h after delivery. All of the women attained adequate LPV levels through 30 days postpartum. No serious adverse events were reported.

Association of low CD4 cell count and intrauterine growth retardation in Thailand.

OBJECTIVE: Each year, intrauterine growth retardation (IUGR) affects 20-30 million neonates worldwide, mostly in resource-limited settings. Increased perinatal and infant mortality has been associated with IUGR. Some studies have suggested that HIV infection could increase the risk of IUGR. To confirm this hypothesis, we examined the association between HIV-related factors and the risk of IUGR in Thailand. PATIENTS AND METHODS: Data from a cohort of 1436 HIV-infected pregnant women enrolled in the "Perinatal HIV Prevention Trial-1", a clinical trial conducted from 1997 to 1999 in Thailand, were analyzed using a logistic regression, adjusting for risk factors usually associated with IUGR. RESULTS: The rate of IUGR was 7.6%. Adjusting for a short maternal height, low body mass index, small weight gain during pregnancy, and infant female sex, a low maternal CD4 percentage was independently associated with IUGR (odds ratio 0.96, per 1% increment, 95% confidence interval 0.93 to 0.99, P = 0.03). CONCLUSIONS: The current World Health Organization recommendation to initiate combination antiretroviral therapy for immunocompromised women as early as possible during pregnancy for their own health and for the prevention of HIV mother-to-child transmission is likely to also decrease the incidence of IUGR. Encouraging immunocompromised HIV-infected women who plan to become pregnant to wait until immune restoration has been achieved may help to reduce the risk of IUGR.

Risk factors for primary postpartum hemorrhage in Bhumibol Adulyadej Hospital.

BACKGROUND: Postpartum hemorrhage remains one of the main causes of maternal morbidity and mortality in both developed and developing countries. Hemorrhages account for 28%of all direct maternal deaths and remain the most common cause of direct maternal deaths worldwide. OBJECTIVE: To study the incidence and risk factors for postpartum hemorrhage (PPH) in Bhunibol Adulyadej Hospital. MATERIAL AND METHOD: Retrospective cohort study of 19,429 patients who gave birth between P' January 2004 and 31st December 2007 at Bhumibol Adulyadej Hospital. One thousand five hundred and thirty women were enrolled in the present study, three hundred and eighty five women had postpartum hemorrhage and one thousand one hundred and forty-five had no postpartum hemorrhage. The present study analyzed one postpartum hemorrhage woman compared to three women who gave birth in nearly the same period and had no postpartum hemorrhage both vaginal deliveries and cesarean section. RESULTS: The PPH rate in Bhumibol Adulyadej Hospital was 1.98%. Maternal age, height and fetal birth weight were not different between the PPH group and no PPH group. The strongest risk factors for postpartum hemorrhage in the present study were prolonged 3rd stage of labor, retained placenta, lacerations of birth passage, and placenta previa. CONCLUSION: The strongest risk factors for postpartum hemorrhage in the present study were prolonged 3rd stage of labor, retained placenta, lacerations of birth passage, and placenta previa.

Efficacy of external cephalic version with tocolysis in late pregnancy.

OBJECTIVE: To study the success rate and identify factors influencing the success rate of external cephalic. version (ECV) at Bhumibol Adulyadej Hospital. STUDY DESIGN: Prospective descriptive study. SETTING: Department of Obstetrics and Gynecology, Bhumibol Adulyadej Hospital. MATERIAL AND METHOD: All parturients attending the obstetrics unit at Bhumibol Adulyadej Hospital between October 1, 1997 and September 30, 2006, having completed 36 or more gestational weeks with singleton non-vertex fetus, who had no exclusion criteria for ECVwere given full information concerning a trial of ECV risk of cesarean section, and risk of emergency breech deliveries. Those who chose to undergo ECV after counseling were recruited and gave signed consent. One hundred and forty singleton, pregnant women with non-vertex presentation participated in this study. RESULTS: The success rate of ECV was 71.43%. Birth weight significantly affected the success rate of ECV Maternal weight, parity, gestational age, and placental site did not have any effect on the outcome. All fetuses in the present study were subsequently delivered without significant morbidity and no cases of perinatal mortality were recorded. CONCLUSION: ECV is a safe procedure with a high success rate in selective cases. ECV thus, is an effective alternative practice for non-vertex presentation, which can also reduce the rate of breech delivery and cesarean section. The major benefits of external cephalic version are reduced maternal morbidity and mortality from surgery.