Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 402
- 试验地点
- 16
- 主要终点
- Gestational age at delivery
研究概览
简要总结
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.
Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.
Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).
Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent must be obtained before any study assessment is performed;
- •18 years of age or older;
- •Singleton pregnancy;
- •Pregnancy consultation between 8 and 10 weeks gestation.
- •At least one of the following risk factors for spontaneous preterm birth:
- •Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency
- •PPROM ≤36 weeks in previous pregnancy
- •Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.
排除标准
- •Patients who are already using pro-, pre- or synbiotics and not willing to stop
- •Multiple pregnancy
- •Need for primary (type 1) cerclage
- •Inflammatory bowel disease
- •Known congenital uterine anomaly
- •History of LLETZ conization
结局指标
主要结局
Gestational age at delivery
时间窗: Through study completion - at delivery
次要结局
- Proportion of PTB in different categories(Through study completion - at delivery)
- Neonatal outcome: periventricular leukomalacia(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Incidence of PTB, defined as GA at delivery < 37 weeks(Through study completion - at delivery)
- Duration of neonatal admissions(Neonatal admission at a neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Incidence of maternal admissions(Up to 34 weeks from the date of randomization)
- Neonatal outcome: bronchopulmonary dysplasia (BPD)(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Neonatal outcome: intraventricular haemorrhage(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Neonatal outcome: respiratory support(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Neonatal outcome: retinopathy(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Neonatal outcome: birth weight(After the neonate is born)
- Composition of the vaginal microbiome(Assessed 3 times during the study period: at randomization, 11-13 weeks after randomization (at gestational age 19-21 weeks), and 21-23 weeks after randomization (29-31 weeks of gestation))
- Incidence of neonatal admissions(Neonatal admission at a neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Duration of maternal admissions(Up to 34 weeks from the date of randomization)
- Quality Of Life during pregnancy and during neonatal admission at a neonatal intensive care unit(Trough study completion, on average 1 year)
- Neonatal outcome: infectious parameters(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- Neonatal outcome: neonatal morbidity(During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery))
- PPROM(Up to 34 weeks from the date of randomization)