Evaluation of the Efficacy of Chlorhexidine Use During the First Trimester as a Regulator of Vaginal Microbiota in Reducing Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,117
- 试验地点
- 1
- 主要终点
- Preterm birth
研究概览
简要总结
The aim of this prospective observational study was to evaluate the efficacy of a universal strategy of primary prevention of preterm birth using intravaginal chlorhexidine (CLX) applied before 16 weeks.
The main question is whether universal treatment with vaginal CLX before 16 weeks would reduce the incidence of preterm birth, especially before 34 weeks.
Participants were recruited at the routine first trimester consultation. All patients underwent an initial ultrasound examination between 6+0 and 15+6 weeks gestation, including assessment of embryo/fetus vitality.
Antiseptic treatment aimed at reducing possible bacterial overgrowth consisted of 10 days (1 box) of CLX vaginal ovules (CLX digluconate 0.2%) always starting between 9+0 and 16+0 weeks.
As this product is widely marketed and frequently indicated in gynaecology, we did not deprive the non-treated group of treatment because we wanted to assess whether it could have an effect on reducing preterm delivery.
The pregnant women were then followed up until the end of pregnancy and compared with a cohort of patients who had not received any treatment.
All data related to delivery were collected, as well as any events related to preterm delivery, such as onset of contractions, cervical shortening and premature rupture of membranes, regardless of final gestational age at delivery.
详细描述
Clinical implications of the study:
The clinical implications of our project would be to counteract the effect of pathogenic bacteria from the beginning of pregnancy (outside the teratogenic period) with the administration of the CLX ovules and thus enhance the action of the normal vaginal microbiota in the pregnant patient, since the glycogen available due to hormonal action favours the growth and development of lactobacillus, responsible for its protective activity against pathogens during pregnancy.
Sample size:
The approximate number of births per year in Spain is 370,000. The minimum number of patients to be recruited would be 400 with a 95% confidence interval.
Patients were recruited as they attended the consultation where the PI and/or collaborators were present.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant patients from the 9 weeks until 15weeks 6 days who attend the first trimester check-up
排除标准
- •Patients with a history of previous preterm birth.
- •Patients with vaginal bleeding during the first trimester.
- •Patients with abnormalities detected in the first trimester ultrasound scan.
- •Twin pregnancies
- •Patients with a known allergy to the topical use of Chlorhexidine in any of its forms of presentation.
结局指标
主要结局
Preterm birth
时间窗: 9 months
Vaginal delivery before 34 weeks
次要结局
- Cervical shortening(9 months)
- Threatened preterm labor(9 months)
- Premature rupture of membranes(9 months)