Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg County in Sweden and the Effect on Spontaneous Preterm Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 主要终点
- preterm delivery
研究概览
简要总结
Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy could reduce the risk for preterm delivery.
Women were screened for bacterial vaginosis during the first visits at the maternal health care unit with a vaginal sample that were taken by the midwife or by herself. After the vaginal samples was air dried it was sent to the gynaecological department and was investigated using Hay/Ison classification. Eligible women were those who had lived in Skaraborg and delivered at Skaraborg hospital.
详细描述
The study has started 2007 and will continue until 2014. Pregnant women that will come to the maternal health care units in gestational week 8-11 will be offered to be screened for bacterial vaginosis. A vaginal sample will be taken by the midwife or by the women herself. The vaginal sample is air-dried and sent to the gynecological. There it is investigated using Hay/Ison classification for the diagnosis of bacterial vaginosis.
Women with bacterial vaginosis will be offered treatment with topical clindamycin treatment for 7 days if the women has passed the 12th gestational week. A control sample for the test of cure will be done after 10 week. If not cured of BV she will be offered a new treatment.
All women will be followed until delivery.
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 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women screened for bacterial vaginosis in early pregnancy
排除标准
- •women not delivered at Skaraborg hospital.
研究组 & 干预措施
treatment of bacterial vaginosis
women with bacterial vaginosis will be offered treatment with clindamycin-2-phosphate
干预措施: Clindamycin-2-phosphate (Drug)
结局指标
主要结局
preterm delivery
时间窗: before 37th week of gestation
次要结局
- cure of bacterial vaginosis(after 10 weeks)
研究者
Per-Goran Larsson
Professor Consultat
Skaraborg Hospital