Screening for Bacterial Vaginosis Screening at IUD Insertion: Is There a Role?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain/cramping
研究概览
简要总结
A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.
排除标准
- •pregnancy
- •a previous history of ectopic pregnancy or pelvic inflammatory disease
- •HIV positive or immunocompromised
- •unable to understand English
- •unable to give informed consent
结局指标
主要结局
Pain/cramping
时间窗: 1 month
Participants will be asked to monitor for any signs or symptoms of infection, such as pelvic pain, foul purulent discharge or fever \> 38oC.
Expulsion
时间窗: 1 month
At the 1-month follow-up visit, repeat swabs for BV will be taken and we will also checking that the IUD is still in place, by the presence of visible IUD strings at the cervical os.
Rate of abnormal bleeding
时间窗: 1 month
In the study population, we will calculate the number of women who have BV at the time of IUD insertion. In order to assess abnormal bleeding, participants will be asked to keep a menstrual calendar denoting the bleeding characteristics (heavy, normal, light flow or spotting).
Pelvic infection
时间窗: 1 month
Participants will be asked to monitor for any signs or symptoms of infection, such as pelvic pain, foul purulent discharge or fever \> 38oC.
次要结局
- Occurence of new onset BV infection(1 month post-IUD insertion)