OBJECTIVETo explore the clinical value of screening the serum markers during the second trimester of pregnancy in preventing congenital birth defect and predicting the pregnancy outcome.

METHODSBetween November, 2011 and October, 2013, a total of 25 520 pregnant women (15-20+6 gestational weeks) underwent a screening test of triple serum markers including free beta-human chorionic gonadotrophin (free βhCG), alpha-fetoprotein (AFP), and unconjugated estriol (µE3) during the second semester of pregnancy. The women identified by the screening test as having high risks were referred to invasive prenatal diagnosis by amniocentesis, or to color Doppler ultrasound examination for suspected patent neural tube defect (NTD), and their pregnancy outcomes were followed up.

RESULTSHigh-risk pregnancies were identified by the screening test in 4.91% (1254/25520) of the total cohort. Of the 818 patients receiving invasive prenatal diagnosis, the abnormal rate was 5.75% (47/818). The high-risk pregnancies identified by the screening test was associated with a significantly higher rate of abnormal outcomes compared with the low-risk pregnancies (1.91% vs 0.1%, P<0.01). Of the 210 high-risk cases of NTD, a definite diagnosis was established in 34 cases. We also found that pregnancies at an advanced age (>35 years) was associated with increased risks for trisomy 21 compared with those at younger ages (15% vs 1.65%P<0.01). The detection rate of abnormal karyotypes in pregnancies with an abnormal MoM value of a single marker was 3.17% (6/189).

CONCLUSIONScreening tests of serum markers during the second trimester of pregnancy can be helpful to identify fetal chromosomal and anatomical anomalies, predict unfavorable pregnancy outcomes, and prevent birth defects in pregnancies at an advanced age. The MoM value of a single marker in the second trimester can be indicative of potential chromosomal abnormalities.

Biomarkers ; blood ; Chorionic Gonadotropin, beta Subunit, Human ; blood ; Chromosome Aberrations ; Down Syndrome ; diagnosis ; Estriol ; blood ; Female ; Humans ; Neural Tube Defects ; diagnosis ; Pregnancy ; Pregnancy Outcome ; Pregnancy Trimester, Second ; blood ; Prenatal Diagnosis ; alpha-Fetoproteins ; analysis

OBJECTIVETo establish the median of serum markers for second trimester screening in Qingdao region and to assess the influence of median correction on the performance of screening.

METHODSMaternal serum alpha-fetoproteins (AFP), human chorionic gonadotrophin, free beta subunit (β -HCG) and unconjugated oestriol (uE3) were assayed for prenatal screening of 18 188 singleton pregnancies at 15-20(+ 6) weeks gestation from January 2009 to July 2010. The median of serum markers was calculated based on above results and applied for risk estimation in screening for fetal aneuploidy from August 2010 to March 2011. The screening performance, specified in terms of detection rates (DRs), false positive rates (FPRs) and odds of being affected given a positive result (OAPR) were compared between the two groups. The risks of 45 affected pregnancies detected during the study were estimated with both Caucasian and corrected medians.

RESULTSThe average level of AFP in local pregnancies was similar to that of the Caucasian population, whilst β -HCG and uE3 were respectively 11% and 33% higher than those of Caucasians. The multiple of median (MoM) value was between 0.94 and 1.02 for the dataset based on the corrected median. At a cut-off of l in 270, FPR has decreased from 5.2% to 4.9%, and DR of Down syndrome has increased from 60% to 69.2%, and OAPR has increased from 1:79 to 1:59 when evaluating risk based on the corrected median. For the 45 affected pregnancies, three Down syndrome pregnancies could be missed because their risk estimates were lower than the cut-off level based on Caucasian median.

CONCLUSIONIt is useful to establish and apply population and laboratory-specific medians in order to improve the performance of prenatal screening and diagnosis.

Adult ; Biomarkers ; blood ; Estriol ; blood ; Female ; Humans ; Lindane ; blood ; Pregnancy ; Pregnancy Trimester, Second ; Prenatal Diagnosis ; methods ; alpha-Fetoproteins ; analysis

OBJECTIVETo provide basis for selecting the suitable method of Down's syndrome biochemical screening in the second trimester pregnancy.

METHODSA total of 30 547 singleton pregnancies between 14 and 20(+ 6) weeks of pregnancy were collected and analyzed for maternal serum alpha-fetoproteins (AFP) and human chorionic gonadotrophin, free beta subunit (beta-HCG) with or without unconjugated estriol (uE3). The screening risks were calculated using the software Lifecycle. The detection rates and the cost of per Down's syndrome detected were calculated and compared. And four different methods were compared in a series of 64 serum samples from Down's syndrome pregnancies.

RESULTS(1) Among the 64 affected cases, the detection rate of Down's syndrome was improved no matter in the double test (DT) or in the triple test (TT) if software Lifecycle (LC) was used to evaluate risks. And it was not suitable to evaluate risks with software 2T-Risks in the triple tests. (2) In the cohort of 30 547 singleton pregnancies, the detection rate of Down's syndrome with project DT-LC, which was double test using AFP and free beta-HCG together with software Lifecycle, and project TT-LC, which was triple test using AFP, free beta-HCG and uE3 together with software Lifecycle, was 56.25% and 57.14%, respectively. The former project was better because it decreased the false positive rate at a lower running cost.

CONCLUSIONThe DT-LC is an effective screening strategy for second trimester detection of fetal Down's syndrome in mainland China.

Adult ; Chorionic Gonadotropin, beta Subunit, Human ; blood ; Down Syndrome ; blood ; diagnosis ; Estriol ; blood ; Female ; Genetic Testing ; methods ; Humans ; Pregnancy ; Pregnancy Trimester, Second ; blood ; Prenatal Diagnosis ; economics ; methods ; Young Adult ; alpha-Fetoproteins ; metabolism

Urinary tract infection (UTI) is the most common bacterial infection in women in general and in postmenopausal women in particular. Two groups of elderly women with recurrent UTI should be differentiated regarding age and general status: healthy, young postmenopausal women aged 50 to 70 years who are neither institutionalized or catheterized and elderly institutionalized women with or without a catheter. Bacteriuria occurs more often in elderly functionally impaired women, but in general it is asymptomatic. However, the risk factors associated with recurrent UTI in elderly women are not widely described. In a multivariate analysis it was found that urinary incontinence, a history of UTI before menopause, and nonsecretor status were strongly associated with recurrent UTI in young postmenopausal women. Another study described the incidence and risk factors of acute cystitis among nondiabetic and diabetic postmenopausal women. Independent predictors of infection included insulin-treated patients and a lifetime history of urinary infection. Borderline associations included a history of vaginal estrogen cream use in the past month, kidney stones, and asymptomatic bacteriuria at baseline. Another important factor in postmenopausal women is the potential role that estrogen deficiency plays in the development of bacteriuria. There are at least two studies showing a beneficial effect of estrogen in the management of recurrent bacteriuria in elderly women. One of these studies showed that vaginal estrogen cream reduced vaginal pH from 5.5+/-0.7 to 3.6+/-1.0, restored lactobacillus, and decreased new episodes of UTI. Another study reported similar results using an estriol vaginal ring. However, contradictory results are found in the literature. For example, additional studies found that the use of estriol-containing vaginal pessaries was less effective than oral nitrofurantoin macrocrystals in preventing UTI in postmenopausal women. Two other studies also did not find any benefit in the reduction of UTI by oral estrogen therapy. Unfortunately, the use of estrogen in preventing UTI in postmenopausal women remains questionable. New strategies have been researched for reducing the use of antibiotics in the prevention and treatment of UTI. Two of them are probiotics and cranberry juice or capsules. Although several studies regarding probiotics and cranberry juice or capsules have reported a reduction of episodes of UTI, there is no conclusive evidence that they are useful in the prevention of UTI in postmenopausal women. As for the optimal drug, dosage, and length of treatment for UTI in the elderly, there are no studies comparing these data with the treatment for young women.
Aged ; Anti-Bacterial Agents ; Bacterial Infections ; Bacteriuria ; Capsules ; Catheters ; Contraceptive Devices, Female ; Cystitis ; Estriol ; Estrogens ; Female ; Humans ; Hydrogen-Ion Concentration ; Incidence ; Kidney Calculi ; Lactobacillus ; Menopause ; Multivariate Analysis ; Nitrofurantoin ; Pessaries ; Probiotics ; Risk Factors ; Urinary Incontinence ; Urinary Tract ; Urinary Tract Infections ; Vaccinium macrocarpon

BACKGROUND: Antenatal screening for Down's syndrome has been developed and improved over the past 20 yr. Recently, integrated test, which combines the first and second trimester markers has shown the highest detection rate (DR) and lowest false positive rate (FPR) among Down's syndrome screening tests currently in use. The purposes of this study were to evaluate the screening performance of integrated test and to compare the results with triple test studies in Korea. METHODS: The study population consisted of Korean pregnant women who underwent triple or integrated test between April 2005 and December 2008. Triple test was performed using measurements of alpha-fetoprotein (AFP), unconjugated estriol (uE3), and human chorionic gonadotropin (hCG) in the second trimester. Integrated test was performed using nuchal translucency (NT) by ultrasonography and pregnancy-associated plasma protein A (PAPP-A) from maternal serum in the first trimester, and AFP, uE3, hCG, and inhibin-A in the second trimester. The screening performance of each test was evaluated by DR and FPR. RESULTS: Twenty-seven Down's syndrome pregnancies were confirmed in women screened by triple (N=6,736) or integrated test (N=7,688). At 1:100, 1:270, and 1:300 of risk cutoff, triple test showed 45%, 73%, and 73% of DR and 4.7%, 11.2%, and 12.4% of FPR, respectively. At 1:100, 1:150, and 1:300 of risk cutoff, integrated test showed 63%, 69%, and 75% of DR and 1.5%, 1.9%, and 3.0% of FPR, respectively. CONCLUSIONS: Integrated test showed higher DR and lower FPR, demonstrating better screening performance than triple test.
alpha-Fetoproteins ; Chorionic Gonadotropin ; Down Syndrome ; Estriol ; Female ; Humans ; Korea ; Mass Screening ; Nuchal Translucency Measurement ; Plasma ; Pregnancy ; Pregnancy Trimester, First ; Pregnancy Trimester, Second ; Pregnant Women ; Prenatal Diagnosis ; Staphylococcal Protein A

Bioidentical hormone therapy (BHT) refers to the use of hormones that are molecularly and chemically identical to endogenous hormones for purposes of hormone replacement therapy. The specific hormones used in BHT include estrone, estradiol, estriol, progesterone and testosterone. Since the result of the Women's Health Initiative (WHI) trial documented the increased risk of breast cancer, cardiovascular disease and stroke in users of conventional hormone therapy (CHT), use of CHT has declined and there has been increased interest in BHT. Bioidentical hormones have some distinctly different physiologic effects compared with synthetic hormones. Synthetic progestin is associated with an increased risk for breast cancer and cardiovascular disease, while natural progesterone is associated with a decreased risk of breast cancer and cardiovascular disease. Estriol has some unique physiologic effects, which differentiate it from estrone and estradiol. Estriol is associated with a lower risk of breast cancer and would be expected to prevent breast cancer, but few randomized controlled trials have been documented. Some clinical data demonstrate that BHT is associated with a lower risk of breast cancer and cardiovascular disease, and is more efficacious than synthetic hormones. However, there is little evidence in support of this claim. Moreover, estriol has not been approved by the U.S. Food and Drug Administration (FDA). Further studies are needed to confirm the safety and efficacy of BHT.
Breast Neoplasms ; Butylated Hydroxytoluene ; Cardiovascular Diseases ; Estradiol ; Estriol ; Estrone ; Female ; Hormone Replacement Therapy ; Humans ; Menopause ; Progesterone ; Stroke ; Testosterone ; United States Food and Drug Administration ; Women's Health

Bioidentical hormone therapy (BHT) refers to the use of hormones that are molecularly and chemically identical to endogenous hormones for purposes of hormone replacement therapy. The specific hormones used in BHT include estrone, estradiol, estriol, progesterone and testosterone. Since the result of the Women's Health Initiative (WHI) trial documented the increased risk of breast cancer, cardiovascular disease and stroke in users of conventional hormone therapy (CHT), use of CHT has declined and there has been increased interest in BHT. Bioidentical hormones have some distinctly different physiologic effects compared with synthetic hormones. Synthetic progestin is associated with an increased risk for breast cancer and cardiovascular disease, while natural progesterone is associated with a decreased risk of breast cancer and cardiovascular disease. Estriol has some unique physiologic effects, which differentiate it from estrone and estradiol. Estriol is associated with a lower risk of breast cancer and would be expected to prevent breast cancer, but few randomized controlled trials have been documented. Some clinical data demonstrate that BHT is associated with a lower risk of breast cancer and cardiovascular disease, and is more efficacious than synthetic hormones. However, there is little evidence in support of this claim. Moreover, estriol has not been approved by the U.S. Food and Drug Administration (FDA). Further studies are needed to confirm the safety and efficacy of BHT.
Breast Neoplasms ; Butylated Hydroxytoluene ; Cardiovascular Diseases ; Estradiol ; Estriol ; Estrone ; Female ; Hormone Replacement Therapy ; Humans ; Menopause ; Progesterone ; Stroke ; Testosterone ; United States Food and Drug Administration ; Women's Health

BACKGROUND: Maternal serum prenatal quadruple screening includes testing for alpha-fetoprotein (AFP), human chorionic gonadotrophin (hCG), unconjugated estriol (uE3), and dimeric inhibin A (DIA). We evaluated quadruple screening using an automated platform and looked for any ethnic differences in the median values of each marker. METHODS: We measured the concentrations of each quadruple test analyte using the UniCel DxI 800 system (Beckman Coulter, USA) in 788 Korean mid-trimester maternal serum samples and calculated their median values using Benetech software (Benetech, Canada). We also compared the results with those obtained using the Immulite 2000 assay (Siemens Healthcare Diagnostics, USA) or ELISA (DSL, USA) in 442 samples. RESULTS: We obtained mid-trimester median values for each marker. The following are the comparative results for each test using the Immulite 2000 assay or ELISA (x) and the UniCel DxI 800 immunoassay (y): AFP, y=1.10x+0.01, r=0.925; uE3, y=0.28x+0.24, r=0.885; hCG, y=1.22x-3047.8, r=0.944; and DIA, y=0.86x+15.31, r=0.833. Assay results for each of the four markers showed good correlations. However, significant biases necessitated new median calculations of prenatal risk estimates in all four tests. CONCLUSIONS: We established gestational age-specific second-trimester median values for four markers in Korean samples using the UniCel DxI 800 immunoassay system. Despite significant bias, there were good correlations between the results obtained using the UniCel DxI 800 immunoassay and those obtained using the Immulite 2000 assay.
Biological Markers/blood ; Chorionic Gonadotropin/blood ; Enzyme-Linked Immunosorbent Assay ; Estriol/blood ; Female ; Gestational Age ; Humans ; Immunoassay/instrumentation/*methods ; Inhibins/blood ; Pregnancy ; Pregnancy Trimester, Second ; *Prenatal Diagnosis ; Reference Values ; Republic of Korea ; alpha-Fetoproteins/analysis

OBJECTIVES: The aim of this study was to assess atrophic symptoms, the vaginal maturation index (VMI), and vaginal pH in postmenopausal women after use of estriol vaginal tablets for the treatment of vaginal atrophy. METHODS: In a randomized prospective study, 67 postmenopausal women were treated with 500microg estriol tablets 3 times a week for 1 week in the 1-week treatment group (n = 40) and for 2 weeks in the 2-week treatment group (n = 27). The primary endpoints were changes in the VMI, vaginal pH, and improvement in participant-reported most bothersome symptom (MBS; vaginal dryness, irritation/itching, or dyspareunia). We compared three endpoints before and after treatment in each group and between the two treatment groups. The correlation between the vaginal pH and maturation value (MV) was assessed. RESULTS: A statistically significant increase in the MV, decrease in pH, and improvement in the MBS occurred for women treated with estriol vaginal tablets in the 1- (P = 0.000, P = 0.002, and P = 0.000, respectively) and 2-week treatment groups (P = 0.000, P = 0.000, and P = 0.000, respectively). There were no significant differences between the 1- and 2-week treatment groups with respect to improvement in the VMI, vaginal pH, or MBS. The correlation between the vaginal pH and MV showed a negative linear correlation at 0, 1, and 2 weeks (P = 0.000, P = 0.000, and P = 0.011, respectively). CONCLUSION: Treatment with 500microg estriol vaginal tablets thrice-weekly for 1 week was effective in improving. It is thought that the three primary endpoints (VMI, vaginal pH, and MBS) improved at the same time during treatment.
Estriol ; Estrogens ; Female ; Humans ; Hydrogen-Ion Concentration ; Prospective Studies ; Tablets ; Vaginal Creams, Foams, and Jellies

OBJECTIVE: To compare the differences in the second trimester Quad test markers in patients who subsequently developed preeclampsia depending on the disease onset time and the presence of fetal growth restriction (FGR). METHODS: A retrospective study was carried out on 66 women with severe preeclampsia and 345 controls who were delivered at Dong-A University hospital and Ilsin Christian Hospital from January 2006 to December 2008. Severe preeclampsia patients were grouped according to with (n=30) or without (n=36) FGR. Severe preeclampsia patients were also grouped according to early onset (n=16) or late onset (n=50) The levels of the second trimester human chorionic gonadotropin (hCG), inhibin-A, unconjugated estriol (uE3), alpha-fetoprotein (AFP) were compared in each group. RESULTS: In the pregnancies that subsequently developed severe preeclampsia, the second trimester hCG, inhibin-A and AFP were significantly higher than the controls. We found that levels of hCG, inhibin-A in severe preeclampsia complicated by FGR were significantly higher than those without FGR. We also found that levels of AFP and inhibin-A in early onset severe preeclampsia were significantly higher than late onset severe preeclampsia. CONCLUSION: The levels of second trimester Quad test markers in patients that subsequently developed severe preeclampsia were different according to with or without FGR and onset time.
Adenine ; alpha-Fetoproteins ; Carbamates ; Chorionic Gonadotropin ; Deoxycytidine ; Drug Combinations ; Estriol ; Female ; Fetal Development ; Humans ; Organophosphonates ; Pre-Eclampsia ; Pregnancy ; Pregnancy Trimester, Second ; Quinolones ; Retrospective Studies ; Thiazoles ; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination