RESUMO
OBJECTIVES: The objective of this study was to evaluate the efficacy of Unicenta (UNCNT) and Melsmon in women with the menopausal symptoms, by analysing the changes in the Kupperman index (primary endpoint), and the hormonal change (secondary endpoint). METHODS: This is a randomized, multi-Center, double-Blind, parallel, non-inferiority clinical study of four different tertiary medical centers. We began the participant recruitment in September 2011, with 218 patients applied over 7 months. All participants had the last visit in April 2012. RESULTS: The Unicenta injection was not inferior to that of Melsmon as measured by the Kupperman index following the injection in both the intent-to-treat and the per-protocol populations (P = 0.63, P = 0.85, respectively). Side effects occurred in 14.0% of the cases (15 patients/18 cases) in the case group, and in 12.6% (14 patients/15 cases) in the control group (P value=0.7599). None were reported to be associated with the medication. The laboratory results and the vital signs showed no statistically significant risk for safety. CONCLUSION: The study showed that Unicenta is not inferior to Melsmon in the change of the Kupperman index after 12 days of injection. The efficacy and safety of Unicenta was shown, with the improvement of the menopausal symptoms.
Assuntos
Feminino , Humanos , Menopausa , Sinais VitaisRESUMO
BACKGROUND: During seasonal influenza epidemics and previous pandemics, pregnant women have been at increased risk for complications related to influenza infection. Although influenza vaccination has been widely recommended to pregnant women and immunocompromised hosts, the vaccination rate is presumed to be low in pregnant women. This study was aimed to evaluate the vaccination rate and factors associated with Influenza vaccination among pregnant women, who are at high risk for developing complications from the influenza. MATERIALS AND METHODS: This study was carried out by telephone survey from April, 2007 to August, 2007. Women who were in their second trimester of pregnancy or above,- during October, 2006 and February, 2007, the recommended vaccination period, and had given birth at Inha University Hospital were selected as the study population. Immunization status, general understanding, and factors associated with vaccination were evaluated. RESULTS: Among a total of 506 eligible pregnant women, 227 (44.8%) responded to the questionnaires. The influenza vaccination rate among the pregnant women was only 4% (9/227). Major reasons for not receiving vaccination were first, not awaring the necessity of immunization during pregnancy (48.5%, 110/227) and second, misunderstanding that it is prohibited during pregnancy (36.1%, 82/227). The major factors that influenced the compliance of vaccination were correct understanding and doctor's recommendation on the influenza immunization during pregnancy. CONCLUSIONS: The influenza vaccine coverage on pregnant women was very low and the awareness of influenza vaccination during pregnancy in general was inaccurate. Shift in perception is required and this can be achieved by educating the pregnant women on the safety and efficacy of vaccination. In addition, doctors' active encouragement to vaccination is highly recommended.
Assuntos
Feminino , Humanos , Gravidez , Complacência (Medida de Distensibilidade) , Imunização , Hospedeiro Imunocomprometido , Vacinas contra Influenza , Influenza Humana , Pandemias , Parto , Segundo Trimestre da Gravidez , Gestantes , Estações do Ano , Telefone , Vacinação , Inquéritos e QuestionáriosRESUMO
BACKGROUND: During seasonal influenza epidemics and previous pandemics, pregnant women have been at increased risk for complications related to influenza infection. Although influenza vaccination has been widely recommended to pregnant women and immunocompromised hosts, the vaccination rate is presumed to be low in pregnant women. This study was aimed to evaluate the vaccination rate and factors associated with Influenza vaccination among pregnant women, who are at high risk for developing complications from the influenza. MATERIALS AND METHODS: This study was carried out by telephone survey from April, 2007 to August, 2007. Women who were in their second trimester of pregnancy or above,- during October, 2006 and February, 2007, the recommended vaccination period, and had given birth at Inha University Hospital were selected as the study population. Immunization status, general understanding, and factors associated with vaccination were evaluated. RESULTS: Among a total of 506 eligible pregnant women, 227 (44.8%) responded to the questionnaires. The influenza vaccination rate among the pregnant women was only 4% (9/227). Major reasons for not receiving vaccination were first, not awaring the necessity of immunization during pregnancy (48.5%, 110/227) and second, misunderstanding that it is prohibited during pregnancy (36.1%, 82/227). The major factors that influenced the compliance of vaccination were correct understanding and doctor's recommendation on the influenza immunization during pregnancy. CONCLUSIONS: The influenza vaccine coverage on pregnant women was very low and the awareness of influenza vaccination during pregnancy in general was inaccurate. Shift in perception is required and this can be achieved by educating the pregnant women on the safety and efficacy of vaccination. In addition, doctors' active encouragement to vaccination is highly recommended.
Assuntos
Feminino , Humanos , Gravidez , Complacência (Medida de Distensibilidade) , Imunização , Hospedeiro Imunocomprometido , Vacinas contra Influenza , Influenza Humana , Pandemias , Parto , Segundo Trimestre da Gravidez , Gestantes , Estações do Ano , Telefone , Vacinação , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To evaluate the accuracy of predicted birth weight percentile and large for gestational age(LGA) fetuses by the gestation-adjusted projection method using estimated fetal weight. METHODS: From 462 low-risk pregnancies with singleton fetus, fetal biometry including fetal biparietal diameter(BPD), head circumference(HC), abdominal circumference(AC), and femur length(FL) was made from 30 weeks of gestation until term. Estimated fetal weight(EFW) by combinations of fetal biometry were made by Campbell, Hadlock1, Hadlock2, and Shepard formulas respectively. The diagnostic accuracy according to 4 formulas was assessed by correlation between EFW percentile and birth weight percentile, prediction of LGA fetuses, and prediction error(percentile difference between birth weight and EFW). RESULTS: The mean gestational age on ultrasound and on birth, and birth weight were 33.21 +/- 2.08(30-40) weeks, 38.43 +/- 1.72(30-42) weeks, and 3.14 +/- 0.47(0.99-4.38) Kg, respectively. The diagnostic accuracies of gestation-projection method using EFW were similar result to predict birth weight percentile and LGA fetuses according to 4 formulas. Correlation between EFW percentile and birth weight percentile(correlation coefficient, r) were Campbell: 0.644(p <0.001), Hadlock 1: 0.682(p <0.001), Hadlock 2: 0.681(p <0.001), Shepard: 0.638(p <0.001), respectively. Youden's index(sensitivity + specificity - 1) in prediction of LGA fetuses were Campbell: 0.532, Hadlock1: 0.525, Hadlock2: 0.520, Shepard: 0.549, respectively. Prediction error were Campbell: 18.14+/-16.56, Hadlock1: 16.19+/-14.35, Hadlock2: 16.10+/-14.29, Shepard: 19.68+/-17.00, respectively. The prediction error was increased according to increasing of lapse time(p <0.001), gestational weeks on ultrasound, and estimated fetal weight percentile, and decreasing birth weight percentile(p <0.001)(R square=0.411, (p <0.001). But, amniotic fluid index did not affect to prediction error(p=0.199). CONCLUSION: Our study presented relatively accurate prediction for birth weight percentile and LGA fetuses from remote sonographic examination. If LGA fetuses was suspected by antenatal ultrasound, adequate therapy and periodic observation are recommended for good perinatal outcome.