Effect of Probiotics on the Preterm Delivery Rate (< 37 Weeks) in Pregnant Women at High Risk for Preterm Birth (Pregnant Women With Threatened Preterm Labour): PROPEV TRIAL Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Preterm birth rate <37 weeks
研究概览
简要总结
Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.
详细描述
Hypothesis
- Pregnant women with threatened preterm labour (TPL) will present vaginal microbiome different from those without TPL.
- Treatment with probiotics will modify the vaginal microbioma of pregnant women with TPL.
- The PB rate before 37 weeks in pregnant women with TPL who have received probiotics since their diagnosis will be reduced by at least 30%.
Goals
- To correlate the use of probiotics of pregnant women with TPL with the PB rate before 37 weeks.
- To ascertain the PB rate before 28, 30, 32 and 34 weeks in both groups.
- To assess neonatal morbidity between both groups.
Methods
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded RCT
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Threatened preterm labour: regular clinical and cardiotography-registered uterine dynamics, and cervical modifications (cervical shortening ≤ 25 mm between 24 and 29 weeks, and ≤ 15 mm between 30 and 34 weeks) according to our care protocol.
- •Single gestation.
- •Echographically-normal foetal morphology.
- •Minimum age 18 years.
- •Ability to understand informed consent.
- •Signed informed consent.
排除标准
- •Multiple gestations.
- •Pregnant women with diagnosis of chorioamnionitis.
- •Cervical dilation.
结局指标
主要结局
Preterm birth rate <37 weeks
时间窗: From 24 to 37 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
次要结局
- Preterm birth rate <34 weeks(From 24 to 34 weeks)
- Intergroup neonatal morbidity(First year of life of newborns)
- Preterm birth rate <32 weeks(From 24 to 32 weeks)
- Preterm birth rate <30 weeks(From 24 to 30 weeks)
- Preterm birth rate <28 weeks(From 24 to 38 weeks)