Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole in Treatment of Bacterial Vagionosis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bacterial Vaginosis treatment
研究概览
简要总结
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological distress and a reduction in quality of life and may be associated with adverse outcomes following a gynecological/obstetrical surgical intervention, such as an increased risk of post-operative infections after pelvic surgery.
It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity
详细描述
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria
symptoms in cases of symptomatic BV include an elevated vaginal pH, grey-white milky vaginal discharge, itching, and a "fishy" odor. moreover, It is well known that unfavorable outcomes of early pregnancy including premature rupture of membranes (PROM), chorioamnionitis, preterm delivery, spontaneous abortion, and low birth weight can be exacerbated by BV during pregnancy.
Aside from the evaluation of clinical symptoms, the gold standard for the confirmation of BV diagnosis is the Nugent score based on Gram staining and observing the number of lactobacilli and other morphotypes (different shapes of gardenerellavaginalis, prevotella species, and mobiluncus) which are scored between 0 and 10, where scores 7-10 show BV. However, traditional assessment using Nugent scoring typically requires more time, resources, and expertise, which can impact its use in a clinical setting. The preferred alternative in practice is the Amsel scoring or a Gram stain.
The Amsel scoring system is simple to use and is based on four predefined criteria: (I) the presence of homogeneous, thin, greyish white vaginal discharge, (II) a vaginal pH over 4.5, (III) a positive whiff-amine test, and (IV) >20% clue cells/high power field on a wet mount of vaginal secretions. Yet, important diagnostic tools for BV are the phase contrast microscope and a trained user.
Oral divided dose metronidazole is the most widely used therapy and serves as the standard of care for bacterial vaginosis. Despite its favorable pharmacodynamics, recurrence rates of BV are high, 69-80% within 12 months. The causes of recurrence are still not known, whether from development of a treatment resistant bacterial biofilm on the vaginal mucosa, reinfection from a sexual partner, or host factors leading to failure to re-establish the normal vaginal flora.Two-thirds of cases complain from bacterial vaginosis recurrence within a year of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years with a clinical diagnosis and laboratory diagnosis as (cervical smear & high vaginal swab) of bacterial vaginosis.
- •Diagnosed with Bacterial vaginosis the Amsel scoring system which requires 3 criteria of 4 criteria for diagnosis.:
- •The presence of homogeneous, thin, greyish white vaginal discharge.
- •Vaginal pH over 4.
- •Positive whiff-amine test (the presence of a fishy odor following addition of KOH to the vaginal sample).
- •More than 20% clue cells/high power field on a wet mount of vaginal secretions.
排除标准
- •Other types of infections based on history and clinical examination as candida vaginitis (itching with cottage cheese whitish discharge, Trichomonas vaginalis (with yellowish green offensive discharge) and any sexually transmitted disease (STDs) as gonorrhea(watery creamy greenish discharge, pain on micturation)syphilis(appearance of shung-kur ulcer, painless sore), chlamydia(abnormal discharge from vagina, burning sensation on peeing, abnormal discharge from penis) or genital herpes (tingling, burning, itching around genitals on both parteners).
- •Pregnant and lactating females
- •Any contraindication or hypersensitivity to metronidazole use
- •Use of other antibiotics or systemic antifungal agents within the previous 2 weeks or planned use within 2 weeks
- •Use of topical vaginal antibiotics, antifungals or acidifying products recently or planned within 2 weeks
- •Atrophic vaginitis
- •Using IUD as contraceptive method because IUD is a risk factor for infection
研究组 & 干预措施
Group A (Clindamycine with Metronidazole)
About 50 female patients used Vaginal Clindamycin vaginal cream: 2% and Oral Metronidazole tablets in the treatment of Bacterial Vaginosis
干预措施: Clindamycin Phosphate (Drug)
Group B (Metronidazole)
About 50 female patients used Metronidazole tables in the treatment of Bacterial Vaginosis
干预措施: Clindamycin Phosphate (Drug)
结局指标
主要结局
Bacterial Vaginosis treatment
时间窗: At 2 weeks and through 6 months
Assessment of the female patients whom suffering from Bacterial Vaginosis by Complete history description to changes of discharge odour and symptoms of vulvovaginitis as itching. and efficacy of both medications (reliving symptoms of BV as discharge \& odour) .
次要结局
未报告次要终点
研究者
Rania Gamal Anwar Elskaan
Lecturer of Obstetrics and Gynecology at Faculty of Medicine
Ain Shams Maternity Hospital