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1.
BMC Infect Dis ; 20(1): 834, 2020 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-33176727

RESUMO

BACKGROUND: Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. METHODS: StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4-10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4-10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. DISCUSSION: Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. TRIAL REGISTRATION: The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111-1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true ).


Assuntos
Antibacterianos/uso terapêutico , Clindamicina/uso terapêutico , Metronidazol/uso terapêutico , Parceiros Sexuais , Vaginose Bacteriana/tratamento farmacológico , Administração Intravaginal , Administração Oral , Antibacterianos/administração & dosagem , Austrália , Clindamicina/administração & dosagem , Feminino , Seguimentos , Humanos , Masculino , Metronidazol/administração & dosagem , Nova Zelândia , Pênis/microbiologia , Estudos Prospectivos , Recidiva , Resultado do Tratamento , Vaginose Bacteriana/microbiologia
2.
PLoS One ; 15(9): e0238748, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32970697

RESUMO

Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.


Assuntos
Infecções por HIV/complicações , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Nascimento Prematuro/prevenção & controle , Nascimento Prematuro/virologia , Progesterona/administração & dosagem , Progesterona/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto/psicologia , Administração Intravaginal , Adulto , Feminino , Humanos , Preferência do Paciente , Inquéritos e Questionários , Zâmbia
4.
Cochrane Database Syst Rev ; 8: CD002845, 2020 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-32845024

RESUMO

BACKGROUND: Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis. OBJECTIVES: The primary objective of this review is to assess the relative effectiveness (clinical cure) of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. Secondary objectives include the assessment of the relative effectiveness in terms of mycological cure, in addition to safety, side effects, treatment preference, time to first relief of symptoms, and costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trials registers on 29 August 2019 together with reference checking and citation searching. SELECTION CRITERIA: We included randomised controlled trials published in any language comparing at least one oral anti-fungal with one intra-vaginal anti-fungal in women (aged 16 years or over) with a mycological diagnosis (positive culture, microscopy for yeast, or both) of uncomplicated vulvovaginal candidiasis. We excluded trials if they solely involved participants who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as recommended by Cochrane. MAIN RESULTS: This review includes 26 trials (5007 participants). Eight anti-fungals are represented. All but three trials included participants with acute vulvovaginal candidiasis. Trials were conducted in Europe: UK (3), Croatia (2). Finland (2), the Netherlands (2), Germany (1), Italy (1), Sweden (1) and one trial across multiple European countries, USA (7) Thailand (2), Iran (2), Japan (1) and Africa (Nigeria) (1). The duration of follow-up varied between trials. The overall risk of bias of the included trials was high. There was probably little or no difference shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short-term follow-up (OR 1.14, 95% CI 0.91 to 1.43; 13 trials; 1859 participants; moderate-certainty evidence) and long-term follow-up (OR 1.07, 95% CI 0.77 to 1.50; 9 trials; 1042 participants; moderate-certainty evidence). The evidence suggests that if the rate of clinical cure at short-term follow-up with intra-vaginal treatment is 77%, the rate with oral treatment would be between 75% and 83%; if the rate of clinical cure at long term follow-up with intra-vaginal treatment is 84%, the rate with oral treatment would be between 80% and 89%. Oral treatment probably improves mycological cure over intra-vaginal treatment at short term (OR 1.24, 95% CI 1.03 to 1.50: 19 trials; 3057 participants; moderate-certainty evidence) and long-term follow-up (OR 1.29, 95% CI 1.05 to 1.60; 13 trials; 1661 participants; moderate-certainty evidence). The evidence suggests that if the rate of mycological cure at short-term follow-up with intra-vaginal treatment is 80%, the rate with oral treatment would be between 80% and 85%; if the rate of mycological cure at long-term follow-up with intra-vaginal treatment is 66%, the rate with oral treatment would be between 67% and 76%. In terms of patient safety, there is a low risk of participants withdrawing from the studies due to adverse drug effects for either treatment (23 trials; 4637 participants; high-certainty evidence). Due to the low certainty of evidence, it is undetermined whether oral treatments reduced the number of side effects compared with intra-vaginal treatments (OR 1.04, 95% CI 0.84 to 1.29; 16 trials; 3155 participants; low-certainty evidence). The evidence suggests that if the rate of side effects with intra-vaginal treatment is 12%, the rate with oral treatment would be between 10% and 15%. We noted that the type of side effects differed, with intra-vaginal treatments being more often associated with local reactions, and oral treatments being more often associated with systemic effects including gastro-intestinal symptoms and headaches. Oral treatment appeared to be the favoured treatment preference over intra-vaginal treatment or no preference (12 trials; 2206 participants), however the data were poorly reported and the certainty of the evidence was low. There was little or no difference in time to first relief of symptoms between oral and intra-vaginal treatments: four trials favoured the oral treatment, four favoured intra-vaginal, one study reported no difference and one was unclear. The measurements varied between the 10 trials (1910 participants) and the certainty of the evidence was low. Costs were not reported in any of the trials. AUTHORS' CONCLUSIONS: Oral anti-fungal treatment probably improves short- and long-term mycological cure over intra-vaginal treatment for uncomplicated vaginal candidiasis. Oral treatment was the favoured treatment preference by participants, though the certainty of this evidence is low. The decision to prescribe or recommend an anti-fungal for oral or intra-vaginal administration should take into consideration safety in terms of withdrawals and side effects, as well as cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.


Assuntos
Antifúngicos/administração & dosagem , Azóis/administração & dosagem , Candidíase Vulvovaginal/tratamento farmacológico , Doença Aguda , Administração Intravaginal , Administração Oral , Antifúngicos/economia , Azóis/economia , Viés , Análise Custo-Benefício , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
5.
Mymensingh Med J ; 29(3): 616-621, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32844802

RESUMO

The objective of this study was to find out the effectiveness and safety of vaginal misoprostol in delivering the dead fetus in cases of intrauterine fetal death (IUFD). This cross sectional study was undertaken among all consecutive patients admitted at the Department of Obstetrics and Gynecology, Dhaka Medical College Hospital, Dhaka, Bangladesh, from October 2012 to September 2013, were included for this study. Vaginal misoprostol was applied in 50 cases that were admitted and diagnosed as a case of IUFD. After taking informed written consent from patients 50µgm of tablet misoprostol was introduced per vaginally into the posterior fornix. Doses were repeated in every 4 hours up to effective contraction to a maximum 6 doses. Follow up was done in hourly interval. Those who did not respond, decision for other methods like oxytocin infusion or LUCS were done. Study showed 60% (n=30) patients belonged to age group of 18-24 years. Among study population 44% (n=22) of the patients belonged to 22-32 weeks of gestation, 30% (n=15) were 33-37 weeks and 26% (n=13) were 38-42 weeks. The causes of intrauterine death were unidentified among 60% (n=30) of cases. Regarding antenatal check up 54% (n=27) had no checkup, 26% (n=13) were irregular and 20% (n=10) were regular. 60% (n=30) of the patients had less Bishop Score <3. Ninety six percent (96%) (n=48) patients responded with vaginal misoprostol and only 4% (n=2) were non responder group. Most 84% (n=42) of the cases needed 2-3 doses, only 8% (n=4) cases needed single dose and 8% (n=4) cases needed 4 to 6 doses. The induction delivery interval varied from 6 to 23 hours and maximum 52% (n=26) of the patients delivered within 12 hours. Adverse effects such as uterine hyper stimulation, tachysystole were not detected. The major complications observed like postpartum hemorrhage 4% (n=2), reduced platelet count 2% (n=1), and chorioamnionitis 4% (n=2). However minor complications like nausea, shivering and mild fever also observed in few cases. Study showed successful induction of labor by misoprostol in a shorter time with significantly less side effects.


Assuntos
Misoprostol , Administração Intravaginal , Adolescente , Adulto , Bangladesh , Estudos Transversais , Feminino , Morte Fetal , Humanos , Trabalho de Parto Induzido , Gravidez , Adulto Jovem
6.
BMC Infect Dis ; 20(1): 491, 2020 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-32650729

RESUMO

BACKGROUND: Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment. METHODS: Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment. RESULTS: The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product. CONCLUSION: Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered. TRIAL REGISTRATION: This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ).


Assuntos
Probióticos/uso terapêutico , Vaginose Bacteriana/microbiologia , Vaginose Bacteriana/terapia , Administração Intravaginal , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Suplementos Nutricionais , Aprovação de Drogas , Feminino , Humanos , Interleucina-1alfa/metabolismo , Adesão à Medicação , Metronidazol/administração & dosagem , Metronidazol/uso terapêutico , Microbiota , Projetos Piloto , Recidiva , Método Simples-Cego , África do Sul , Resultado do Tratamento , Adulto Jovem
7.
Arch Gynecol Obstet ; 302(3): 579-584, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32617665

RESUMO

PURPOSE: To compare the effectiveness of the Cook vaginal cervical ripening balloon (CCRB) with prostaglandin E2 (PGE2) insert for induction of labor in late pregnancy in primipara. METHODS: We evaluated the effectiveness and safety of induction of labor using the improved Bishop score after CCRB or PGE2 administration, total stage of labor, hours until delivery (hours from placement of CCRB or PGE2 insert to parturition and delivery), delivery rate within 24 h, spontaneous delivery rate, successful induction rate, overstimulation syndrome, urgent delivery rate, pain scores, cesarean section rate, and outcomes related to delivery and perinatal morbidity, such as puerperal infection rate, total cost, satisfaction survey, and so on. RESULTS: The improved Bishop Score and delivery rate within 24 h in the CCRB group were significantly higher than in the PGE2 group. The total stage of labor and hours until delivery in the CCRB group were significantly shorter than that in the PGE2 group. Rate of overstimulation syndrome and pain scores in the CCRB group were significantly lower than in the PGE2 group. Compared with the PGE2 group, the mean duration of hospitalization in the CCRB group was shorter and the total cost was less. No difference in satisfaction between the PGE2 and CCRB groups was observed. CONCLUSIONS: Compared with PGE2, CCRB reduced the total stage of labor, hours until delivery, pain scores, mean length of hospitalization, and total cost. CCRB increased the rate of delivery within 24 h with similar safety and maternal satisfaction compared with PGE2.


Assuntos
Maturidade Cervical , Colo do Útero/efeitos dos fármacos , Dinoprostona/administração & dosagem , Trabalho de Parto Induzido/métodos , Ocitócicos/administração & dosagem , Administração Intravaginal , Adulto , Cesárea/estatística & dados numéricos , China , Dinoprostona/uso terapêutico , Feminino , Humanos , Ocitócicos/uso terapêutico , Gravidez , Resultado do Tratamento , Vagina
8.
J. obstet. gynaecol. Can ; 42(6): [806-812], June 01, 2020.
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1117188

RESUMO

To assess the benefits and risks of progesterone therapy for women at increased risk of spontaneous preterm birth (SPB) and to make recommendations for the use of progesterone to reduce the risk of SPB and improve postnatal outcomes. To administer or withhold progesterone therapy for women deemed to be at high risk of SPB. Preterm birth, neonatal morbidity and mortality, and postnatal outcomes including neurodevelopmental outcomes. Intended Users Maternity care providers, including midwives, family physicians, and obstetricians.


Assuntos
Humanos , Feminino , Gravidez , Complicações na Gravidez/prevenção & controle , Administração Intravaginal , Nascimento Prematuro/prevenção & controle , Medida do Comprimento Cervical , Trabalho de Parto Prematuro/prevenção & controle , Progesterona/administração & dosagem
9.
Int J Gynaecol Obstet ; 150(1): 24-30, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32524598

RESUMO

Progestogens (vaginal progesterone and intramuscular 17-hydroxyprogesterone acetate) are widely recommended for women at high risk of preterm birth. Typical regimens include 17-hydroxyprogesterone caproate (250 mg intramuscularly weekly), starting at 16-20 gestational weeks until 36 weeks or delivery for women with a singleton gestation and a history of spontaneous preterm birth, or vaginal progesterone (90-mg vaginal gel or 200-mg micronized vaginal soft capsules) for women with a short cervix (typically ≤25 mm). Although some randomized trials support this approach, neither of the largest trials (PROLONG for 17-hydroxyprogesterone acetate or OPPTIMUM for vaginal progesterone) demonstrated efficacy. There are almost no data on long-term effects, and none that shows benefit beyond the neonatal period. Although some analyses suggest the cost-effectiveness of the approach, a cervical length screening program followed by progesterone for those with a short cervix will reduce preterm birth rates by less than 0.5%. The present review assesses evidence on the efficacy, likely impact, and long-term effects of implementing the recommendations for progestogens in full. Clinicians and pregnant women can look forward to resolution of the conflicting views on efficacy once the Patient-Centered Outcomes Research Initiative (PCORI)-funded individual patient data meta-analysis is published.


Assuntos
17-alfa-Hidroxiprogesterona/administração & dosagem , Nascimento Prematuro/prevenção & controle , Progesterona/administração & dosagem , Progestinas/administração & dosagem , Administração Intravaginal , Adulto , Medida do Comprimento Cervical/economia , Medida do Comprimento Cervical/métodos , Análise Custo-Benefício , Feminino , Humanos , Recém-Nascido , Injeções Intramusculares , Programas de Rastreamento/economia , Gravidez
10.
BMC Womens Health ; 20(1): 108, 2020 05 19.
Artigo em Inglês | MEDLINE | ID: mdl-32429977

RESUMO

BACKGROUND: Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women. METHODS: This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH > 40 IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention. RESULTS: The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76 ± 4.68 to 52.48 ± 7.54) in comparison to the placebo group (increased from 8.58 ± 4.35 to 13.25 ± 5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p = 0.0001). After 8 weeks, 88.6 and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p = 0.001). CONCLUSION: The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended. TRIAL REGISTRATION: IRCT20160602028220N2.


Assuntos
Atrofia/tratamento farmacológico , Ocitocina/administração & dosagem , Pós-Menopausa/efeitos dos fármacos , Vagina/efeitos dos fármacos , Vagina/patologia , Cremes, Espumas e Géis Vaginais/administração & dosagem , Doenças Vaginais/tratamento farmacológico , Administração Intravaginal , Idoso , Método Duplo-Cego , Feminino , Humanos , Irã (Geográfico) , Pessoa de Meia-Idade , Ocitocina/uso terapêutico , Resultado do Tratamento , Cremes, Espumas e Géis Vaginais/uso terapêutico , Doenças Vaginais/patologia
11.
PLoS One ; 15(5): e0232394, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32365097

RESUMO

BACKGROUND: Astodrimer Gel contains a novel dendrimer intended to treat and prevent bacterial vaginosis. We assessed the efficacy and safety of Astodrimer Gel for treatment of bacterial vaginosis. METHODS: 132 women with bacterial vaginosis were randomized 1:1:1:1 to Astodrimer 0.5% (N = 34), 1% (N = 33), or 3% (N = 32) Gel or hydroxyethyl cellulose placebo gel (N = 33) at a dose of 5 g vaginally once daily for 7 days at 6 centers in the United States. The primary endpoint was clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5; 2) ≥20% clue cells; or 3) positive whiff test) at study days 21-30. Secondary analyses included clinical cure at study days 9-12, patient-reported symptoms, acceptability and adverse events. RESULTS: The Astodrimer 1% Gel dose was superior to placebo for the primary and selected secondary efficacy measures in the modified intent-to-treat population. Clinical cure rates at day 9-12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]). At day 21-30, clinical cure rates were 46.2% (12/26) for the 1% dose vs. 11.5% for placebo (3/26; P = .006). A greater proportion of patients reported absence of vaginal discharge and vaginal odor at day 9-12 and day 21-30 for Astodrimer Gel groups compared with placebo. Adverse events considered potentially treatment-related occurred in only 25% of Astodrimer Gel-treated patients vs. 22% of placebo patients. CONCLUSION: Astodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis.


Assuntos
Antibacterianos/administração & dosagem , Dendrímeros/administração & dosagem , Polilisina/administração & dosagem , Descarga Vaginal/tratamento farmacológico , Vaginose Bacteriana/tratamento farmacológico , Administração Intravaginal , Adulto , Antibacterianos/efeitos adversos , Dendrímeros/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Géis , Humanos , Polilisina/efeitos adversos , Resultado do Tratamento , Adulto Jovem
12.
N Engl J Med ; 382(20): 1906-1915, 2020 05 14.
Artigo em Inglês | MEDLINE | ID: mdl-32402161

RESUMO

BACKGROUND: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12. RESULTS: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups. CONCLUSIONS: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).


Assuntos
Antibacterianos/administração & dosagem , Lactobacillus crispatus/fisiologia , Vagina/microbiologia , Vaginose Bacteriana/microbiologia , Vaginose Bacteriana/prevenção & controle , Administração Intravaginal , Adolescente , Adulto , Antibacterianos/efeitos adversos , Antibiose , Método Duplo-Cego , Feminino , Géis , Humanos , Incidência , Lactobacillus crispatus/isolamento & purificação , Metronidazol/uso terapêutico , Pessoa de Meia-Idade , Prevenção Secundária , Vaginose Bacteriana/epidemiologia , Adulto Jovem
13.
Arch Gynecol Obstet ; 302(1): 1-4, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32409923

RESUMO

BACKGROUND: Effective prevention of preterm birth as cause of serious risks for the infant as well as the mother pre- and postpartum is one of the still unsolved problems in modern medicine. METHOD: The government of the State of Thuringia in cooperation with the professional organization of obstetricians and gynecologists decided in 2016 to reestablish and promote a self-care screening program based on intravaginal (i.vag.) pH measurement to reduce the incidence of preterm birth by early diagnosis and therapy of genital infection. RESULTS: Starting at zero in 2016, > 80% of pregnant women in the state had their vaginal pH monitored at the end of 2018 (n = 17.180). This was associated with a reduced incidence of early preterm birth measured by gestational week ≤ 32 (1.46 vs. 1.26%). CONCLUSION: The fourth millennium goal missed worldwide in 2015 as well as the newly declared third objective of the UN could come closer using the simple and cheap i.vag. pH-self-screening regime in prevention of preterm birth, an approach partly turning the woman from being object of medical care to being the subject in self-control of her pregnancy. This is also a well perceived change in paradigm from the perspective of females as well as physicians.


Assuntos
Programas de Rastreamento/métodos , Nascimento Prematuro/epidemiologia , Vagina/química , Aborto Espontâneo/prevenção & controle , Administração Intravaginal , Feminino , Idade Gestacional , Humanos , Concentração de Íons de Hidrogênio , Incidência , Recém-Nascido , Gravidez , Nascimento Prematuro/etiologia , Nascimento Prematuro/prevenção & controle , Vagina/metabolismo , Vagina/microbiologia
14.
Wiad Lek ; 73(2): 239-244, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32248152

RESUMO

OBJECTIVE: The aim: The purpose of the study is a comparative evaluating the effectiveness of using the different methods of treatment of miscarriage in multiple pregnancies taking into account the condition of the cervix. PATIENTS AND METHODS: Materials and methods: 86 pregnant women with diarrheal twins were monitored. On the basis of studying the premorbid background, somatic and reproductive history, features of the gestational period, leading antenatal risk factors for the development of complications in multiple pregnancies were identified. With the help of transvaginal cervicometry the prognostic ultrasound criteria of the condition of the cervix and its obstructive capacity in case of premature birth are investigated. RESULTS: Results: In the event of uncomplicated pregnancy multiple birth is characterized by a gradual shortening of the cervix in dynamics from 43.2 ± 3.9 mm to 38.2 ± 4.0 mm by 20 weeks, from 37.7 ± 4.1 mm to 30.2 ± 3.9 mm to 30 weeks, to 21.1 ± 3.1 mm to 37 weeks. In the period of 25-27 weeks, the appearance of a V-shaped opening of the uterine cervix in half of the women was observed, which remained until the end of gestation. Shortening of the cervix was the most significant in patients with the risk of abortion who received only tocolytic therapy. In the 2nd trimester revealed a V- or U-shaped opening of the cervical canal. In pregnant women at risk who had an obstetric pessary, a decrease in the length of the cervix was found, which was similar to the rate of its shortening in uncomplicated multiple pregnancies. The condition of the cervix in the presence of a pessary before delivery probably did not differ from the condition of the cervix with the normal course of multiple pregnancies. CONCLUSION: Conclusions: Pregnant women with uncomplicated multiple pregnancies revealed a decrease in the length of the cervix with an increase in gestation. At the end of pregnancy, the internal jaws acquired a predominantly Y-shape. In pregnant women with the risk of pregnancy termination who received tocolytic therapy, the cervix was the shortest. In late gestation, V- and U-shaped internal jaws were observed. Changes in the cervix after the placement of obstetric pessaries are similar to changes in uncomplicated pregnancy.


Assuntos
Gravidez Múltipla , Administração Intravaginal , Medida do Comprimento Cervical , Feminino , Humanos , Pessários , Gravidez , Nascimento Prematuro
15.
BJOG ; 127(9): 1055-1063, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32324957

RESUMO

BACKGROUND: Threatened miscarriage is a common complication of pregnancy. Results of randomised controlled trials on the efficacy of progestogen in the treatment of threatened miscarriage remain inconsistent. OBJECTIVE: To investigate whether the use of progestogen is associated with improved event rate of live birth and other benefits in women with threatened miscarriage. SEARCH STRATEGY: Ovid MEDLINE, Ovid Embase and Cochrane CENTRAL Register of Controlled Trials from their inception until 8 July 2019. SELECTION CRITERIA: Randomised controlled trials comparing progestogen with a placebo or no treatment for pregnancy outcomes in women with threatened miscarriage. DATA COLLECTION AND ANALYSIS: Two authors independently conducted data extraction and assessed study quality. We calculated risk ratios (RR) and 95% confidence intervals using the Mantel-Haenszel approach for dichotomous outcomes. MAIN RESULTS: Ten trials with a total of 5056 participants were eligible for analysis. The use of progesterone increased the incidence of live birth (RR 1.07, 95% CI 1.00-1.15; P = 0.04; I2  = 18%), with benefit only seen with the use of oral progestogen (RR 1.17, 95% CI 1.04-1.31; P = 0.008; I2  = 0%) and not with vaginal progesterone (RR 1.04, 95% CI 1.00-1.08; P = 0.07; I2  = 0%). Similarly, progestogen reduced the risk of miscarriage (RR 0.73, 95% CI 0.59-0.92), with benefit only seen with oral progestogen and not with vaginal progesterone. CONCLUSION: Progestogens may have benefits on live birth rate and miscarriage rate for women with threatened miscarriage. These benefits appear to be confined to the use of oral progestogen, and no statistically significant improvements were seen with vaginal progesterone. TWEETABLE ABSTRACT: A meta-analysis of 10 trials found that progestogens increased live birth rates and reduced miscarriage rates for women with threatened miscarriage.


Assuntos
Ameaça de Aborto/tratamento farmacológico , Nascimento Vivo , Progesterona/uso terapêutico , Progestinas/uso terapêutico , Aborto Espontâneo/prevenção & controle , Administração Intravaginal , Administração Oral , Feminino , Humanos , Gravidez , Progesterona/administração & dosagem , Progestinas/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Zhongguo Zhong Yao Za Zhi ; 45(3): 539-547, 2020 Feb.
Artigo em Chinês | MEDLINE | ID: mdl-32237511

RESUMO

To evaluate the traits and rheological properties of thermosensitive in situ gel of Yihuang Decoction and its common gel for vaginal use, and predict the release behavior of Yihuang Decoction in situ gel in vitro. Poloxamer was used as thermosensitive material to prepare Yihuang Decoction vaginal in situ gel, and Yihuang Decoction common gel was prepared with carbopol. Then the differences of the two gels before and after diluting with vaginal fluid were compared. The rheological parameters of Yihuang Decoction in situ gel and its common gel were determined with Anton Paar MCR102 rheometer. In addition, berberine hydrochloride was selected as an index component to evaluate the in vitro release properties of Yihuang Decoction vaginal thermosensitive in situ gel. Yihuang Decoction vaginal thermosensitive in situ gel was Newtonian fluid under low-temperature conditions, which was yellow and transparent. After reaching the gelling temperature of 24.5 ℃, it became semi-solid, pseudoplastic fluid. The gelling temperature was predicted to be 37 ℃, and the phase transition time was 30 s after diluting with simulated vaginal fluid. However, the rheological properties of Yihuang Decoction common gel had no significant changes with temperature. Compared with in situ gel, the color of common gel was darker and more translucent. Besides, its mobility was stronger after diluting with simulated vaginal fluid. The in vitro release study showed that the kinetic behavior of berberine hydrochloride in Yihuang Decoction vaginal thermosensitive in situ gel was matched with the Higuchi equation. Through simulation of vaginal administration, physical properties and dynamic rheological parameters were used to intuitively and scientifically evaluate the two gels. Compared with the common gel, the thermosensitive in situ gel could quickly attached to the vaginal mucosa and release drug, and thus was more suitable for developing vaginal administration of Yihuang Decoction, which also provides references for studying new vaginal preparation of Yihuang Decoction.


Assuntos
Administração Intravaginal , Medicamentos de Ervas Chinesas/química , Géis/química , Feminino , Humanos , Poloxâmero , Reologia , Temperatura , Viscosidade
17.
Cochrane Database Syst Rev ; 4: CD007892, 2020 04 26.
Artigo em Inglês | MEDLINE | ID: mdl-32335895

RESUMO

BACKGROUND: Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane Review first published in 2010 and subsequently updated in 2012, twice in 2014, in 2017 and 2018. OBJECTIVES: To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (7 July 2019), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi-RCTs assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. Cluster-RCTs were eligible for inclusion, but we did not identify any. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design. We included trials published in abstract form only if sufficient information was present in the abstract on methods and outcomes to analyze. DATA COLLECTION AND ANALYSIS: At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies. MAIN RESULTS: We included 21 trials, reporting results for 7038 women evaluating the effects of vaginal cleansing (17 using povidone-iodine, 3 chlorhexidine, 1 benzalkonium chloride) on post-cesarean infectious morbidity. Trials used vaginal preparations administered by sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (17 trials) or the use of a saline vaginal preparation (4 trials). One trial did not report on any outcomes of interest. Trials were performed in 10 different countries (Saudi Arabia, Pakistan, Iran, Thailand, Turkey, USA, Egypt, UK, Kenya and India). The overall risk of bias was low for areas of attrition, reporting, and other bias. About half of the trials had low risk of selection bias, with most of the remainder rated as unclear. Due to lack of blinding, we rated performance bias as high risk in nearly one-third of the trials, low risk in one-third, and unclear in one-third. Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 7.1% in control groups to 3.1% in vaginal cleansing groups (average risk ratio (aRR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; 20 trials, 6918 women; moderate-certainty evidence). This reduction in endometritis was seen for both iodine-based solutions and chlorhexidine-based solutions. Risks of postoperative fever and postoperative wound infection are also probably reduced by vaginal antiseptic preparation (fever: aRR 0.64, 0.50 to 0.82; 16 trials, 6163 women; and wound infection: RR 0.62, 95% CI 0.50 to 0.77; 18 trials, 6385 women; both moderate-certainty evidence). Two trials found that there may be a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82; 2 trials, 499 women; low-certainty evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing. Subgroup analysis suggested a greater effect with vaginal preparations for those women in labour versus those not in labour for four out of five outcomes examined (post-cesarean endometritis; postoperative fever; postoperative wound infection; composite wound complication or endometritis). This apparent difference needs to be investigated further in future trials. We did not observe any subgroup differences between women with ruptured membranes and women with intact membranes. AUTHORS' CONCLUSIONS: Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis, postoperative fever, and postoperative wound infection. Subgroup analysis found that these benefits were typically present whether iodine-based or chlorhexidine-based solutions were used and when women were in labor before the cesarean. The suggested benefit in women in labor needs further investigation in future trials. There was moderate-certainty evidence using GRADE for all reported outcomes, with downgrading decisions based on limitations in study design or imprecision. As a simple intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries. Future research on this intervention being incorporated into bundles of care plans for women receiving cesarean delivery will be needed.


Assuntos
Anti-Infecciosos Locais/administração & dosagem , Cesárea/efeitos adversos , Desinfecção/métodos , Endometrite/prevenção & controle , Cuidados Pré-Operatórios/métodos , Infecção da Ferida Cirúrgica/prevenção & controle , Administração Intravaginal , Compostos de Benzalcônio/administração & dosagem , Clorexidina/administração & dosagem , Feminino , Febre/prevenção & controle , Humanos , Povidona-Iodo/administração & dosagem , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Int J Nanomedicine ; 15: 2027-2044, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32273700

RESUMO

Purpose: As one of the classic anti-Canidia albicans (CA) and vulvovaginal candidiasis (VVC) drugs, nystatin (NYS) is limited by poor water solubility and easy aggregation. Traditional NYS vaginal delivery formulations do not fully adapt to the specific environment of the vaginal cavity. The use of exopolysaccharides (EPS) has great application potential in emulsifiers, but its use has not been reported in nanoemulsions. In this work, an EPS/NYS nanoemulsion (ENNE) was developed to improve the activities of NYS against CA and VVC. Methods: The ENNE was prepared by ultrasonic method using EPS as an emulsifier, liquid paraffin oil as an oil phase, PEG400 as a co-emulsifier, and NYS as the loaded drug. ENNE preparation was optimized by response surface method. After optimization, in vitro and in vivo analysis of the anti-CA activity; animal experiments; staining with propidium iodide (PI), periodic acid-schiff (PAS), and hematoxylin-eosin (H&E); and cytokine experiments were performed to investigate the therapeutic ability against VVC. Results: The optimal formulation and preparation parameters of ENNE were determined as follows: EPS content of 1.5%, PEG400 content of 3.2%, NYS content of 700 µg/mL, paraffin oil content of 5.0%, ultrasonic time of 15 min, and ultrasonic amplitude of 35%. The ENNE showed an encapsulated structure with an average particle size of 131.1 ± 4.32 nm. ENNE exhibited high storage and pH stability, as well as slow release. The minimum inhibitory concentration (MIC) of ENNE against CA was only 0.125 µg/mL and the inhibition zone was 19.0 ± 0.5 mm, for greatly improved anti-CA effect. The prepared ENNE destroyed the membrane of CA cells, and exhibited good anti-CA effect in vivo and therapeutic ability against VVC. Conclusion: The results of this study will promote the application of EPS in nanotechnology, which should lead to new and effective local drug formulations for treating VVC.


Assuntos
Antifúngicos/administração & dosagem , Candidíase Vulvovaginal/tratamento farmacológico , Emulsões/química , Nanoestruturas/administração & dosagem , Nistatina/administração & dosagem , Administração Intravaginal , Animais , Antifúngicos/farmacologia , Candida albicans/efeitos dos fármacos , Citocinas , Emulsificantes/química , Emulsões/administração & dosagem , Feminino , Camundongos Endogâmicos ICR , Testes de Sensibilidade Microbiana , Nanoestruturas/química , Nistatina/farmacologia , Tamanho da Partícula , Polietilenoglicóis/química , Polissacarídeos Bacterianos/química , Ultrassom/métodos
19.
Int J Gynaecol Obstet ; 149(3): 370-376, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32246762

RESUMO

OBJECTIVE: To evaluate the effect of adjunctive use of vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy. METHODS: A randomized controlled trial at Woman's Health Hospital, Assiut University, Egypt, between April 2017 and March 2019 enrolled women eligible for McDonald cerclage. After cerclage, participants were randomly assigned to receive progesterone (400 mg pessary) once daily until 37 weeks or no progesterone. The primary outcome was rate of abortion before 28 weeks. Secondary outcomes included gestational age at delivery, preterm delivery, mean birthweight, Apgar score, and admission to the neonatal intensive care unit (NICU). RESULTS: The rate of spontaneous abortion was higher in the no-progesterone group (P=0.016). Mean gestational age and mean birthweight was higher in the progesterone group (P<0.001 and P=0.002, respectively). The frequency of preterm neonates, neonates with Apgar score less than 7, and admission to NICU was higher in the progesterone group than in the no-progesterone group (P=0.005, P=0.008, and P=0.044, respectively). CONCLUSION: Adjunctive use of vaginal progesterone after McDonald cerclage was found to decrease the frequency of second-trimester abortion and to improve perinatal outcomes in singleton pregnancy. Clinicaltrials.gov: NCT02846909.


Assuntos
Aborto Espontâneo/prevenção & controle , Cerclagem Cervical/métodos , Nascimento Prematuro/prevenção & controle , Progesterona/administração & dosagem , Progestinas/administração & dosagem , Aborto Espontâneo/epidemiologia , Administração Intravaginal , Adulto , Egito , Feminino , Humanos , Recém-Nascido , Gravidez , Segundo Trimestre da Gravidez , Nascimento Prematuro/epidemiologia , Adulto Jovem
20.
Res Vet Sci ; 131: 1-6, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32278134

RESUMO

The characterization of vaginal microbiota will help to understand some of the reproductive problems and mechanisms to improve cattle reproduction. The objective of this study was to characterize the vaginal microbiota of cyclical Holstein cows with different parturition orders using 16S rDNA sequencing. Animals were submitted to an estrus synchronization protocol with the use of intravaginal progesterone (P4) implants and were treated or not with ceftiofur hydrochloride. DNA samples were extracted from vaginal swabs on day 0 and 10 of the synchronization, and sequenced with the Illumina MiSeq platform with an average coverage rate of 10.000 reads per samples using a Single-End library for fragments of 300 bp. The main bacterial phyla found in the vaginal tract of Holstein cows, were Firmicutes (37.61%), Tenericutes (29.45%), Proteobacteria (17.47%) and Bacteriodetes (13.73%), followed by Actinobacteria (0.82%) and Spirochaetae (0.45%). The use of intravaginal P4 devices has increased the relative abundance of the genera Family XIII AD3011 and Family XIII unclassified (p < .049). We have also observed an effect of the number of calving on the vaginal microbiota composition, showing that multiparous cows have a greater bacterial diversity than primiparous animals (p < .05). The use of ceftiofur hydrochloride was effective to reduce the vaginal bacteria proliferation. This study describes for the first time the vaginal microbiota of cows synchronized with intravaginal progesterone devices, different from the traditional methods such as microbiological culture and biochemical tests. We have identified a large number of microorganisms commonly found in the gastrointestinal tract of cows, colonizing the vaginal microbiota.


Assuntos
Bovinos , Sincronização do Estro/métodos , Microbiota/efeitos dos fármacos , Progesterona/farmacologia , Vagina/microbiologia , Administração Intravaginal , Animais , Feminino , Inseminação Artificial/veterinária , Progesterona/administração & dosagem , Progestinas/administração & dosagem , Progestinas/farmacologia , Reprodução
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