Prevalence of Group B Streptococcus Infection in Pregnant Women Conceived Through IVF Diagnosed With Preterm Labor.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percentage of women with GBS infection
研究概览
简要总结
This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART.
221 subjects will be involved.
详细描述
Pregnant women at 20 0/7 to 36 6/7 weeks of gestation, conceived through ART, with signs and symptoms of preterm labor will be recruited.
Anal - vaginal fluid samples will be taken by 2 cotton swabs from each participant for culture. Digital examination will be performed after that. Only participants fulfilling all the study's eligible criteria will be interviewed face-to-face with a questionnaire.
The samples will be sent immediately to My Duc hospital laboratory or will be stored in Stuart-Amies medium in < 4 hours. All culture results are interpreted based on Clinical and Laboratory Standards Institute (CLSI) in 2012.
Statistical analysis was performed by Statistical Package for the Social Sciences (SPSS) v.20 and chi-square test. A p-value of < 0.05 was considered as statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Inclusion Criteria:
- •To be eligible for enrolment into this trial, subject must fulfil all of the following criteria, unless specified otherwise
- •Being conceived through IVF
- •Moderate uterine contractions (2 contractions per 10 minutes, duration < 30 seconds)
- •20 0/7 to 36 6/7 weeks of gestation
- •Intact membrane
- •Cervical dilation ≤ 3 cm
- •Willing to participate into the study
排除标准
- •To be eligible for enrolment in this study each subject must not meet any of the following criteria:
- •Having had intercourse during 24 hours before
- •Being suspected of amniotic leakage
- •Rupture of membrane identified by direct observation through speculum examination of amniotic fluid flow from cervix
- •Vaginal bleeding
- •Being suspected of placenta abruption, placenta previa
- •Having been treated with antibiotics within 1 week before
- •Vaginal douche within 48 hours before
- •Having used vaginal medicines during 48 hours before
- •Having vaginal ultrasound shortly before
- •Urine culture positive with GBS
结局指标
主要结局
Percentage of women with GBS infection
时间窗: 7 days after swab taken
Number of women with GBS infection divided by total number of women under screening
次要结局
未报告次要终点
研究者
Manh Tuong Ho
Doctor
Vietnam National University