Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The primary outcome will be spontaneous preterm birth (sPTB) <34 weeks' gestation.
研究概览
简要总结
The aim of this study is to try and find links between the microscopic organisms (such as bacteria, yeasts and viruses) in the vagina, and twin pregnancies that deliver too early (preterm birth).
Being born earlier than expected (preterm birth) happens in over half of twin pregnancies with 1 in 10 sets of twins delivering before 32 weeks gestation. Sometimes, when birth happens very early, babies can be at risk of serious harm including damage to the brain, lungs and bowel - all of which can result in life changing disabilities. How severe these problems are is related to how early they are born. Unfortunately, tests used to find women at risk of preterm birth have only been proven to work when the woman is carrying one baby, not twins, and at present no treatment has been shown to be effective in stopping a twin pregnancy from delivering early. Preventing twins from being born too early is therefore a target for research by the NHS and patient groups including the James Lind Alliance.
It is normal for every woman to have microscopic organisms (such as bacteria, yeasts and viruses) in the vagina. New interest has been shown at looking closely at these organisms during pregnancy. These organisms can change and may be related to the number of weeks a woman will go into labour, however to date all research on this has been conducted in pregnancies with only one baby.
We want to explore these organisms in twin pregnancies; taking swabs from the vagina at 16- and 28-weeks of your pregnancy, along with at the time of birth. Information will be gathered on the organisms present in the vagina (both of women that deliver too early and those that deliver on time), hoping this information will help us understand why preterm birth happens and help predict the chances of preterm labour in twin pregnancies. By identifying specific organisms linked with preterm birth, we also hope to be able to guide new targets for treatments to prevent preterm birth in twins in future.
Due to the small number of twin pregnancies, measurements of how 'stiff' the neck of the womb (cervix) are along with blood samples will be taken. Research has shown that there may be links with how stiff the neck of the womb is and premature birth as well as markers within the blood that may help us predict preterm birth that are yet to be discovered. This will provide the foundations for a future research study.
详细描述
RATIONALE FOR CURRENT STUDY
The lack of evidence for benefit of any modality for the prevention of sPTB in multiple pregnancies means that novel approaches are urgently needed to address this major health inequality. Despite the growing evidence regarding both vaginal microbiome and vaginal mucosal metabolome and its association with sPTB, no study has analysed these in multiple pregnancies; neither determining any difference to singleton pregnancies or exploring any unique associations with sPTB. Discovering new associations will aide our ability to reliably predict women at highest risk of sPTB and identify those most likely to benefit from screening and intervention.
The overall aim of this study is to assess the vaginal microbiome in multiple pregnancies to ascertain if it differs from singleton pregnancies, comparing results to our large and unique cohort of low and high-risk singletons (Harris-Wellbeing Preterm Birth Centre). In addition, the metabolic profile of the vaginal mucosa will be assessed in multiple pregnancies, working with internationally recognised collaborators to utilise novel DESI MS analysis. This study will be the first to assess both the vaginal microbiome and the vaginal mucosal metabolic profile in multiple pregnancies and to evaluate associations between the vaginal microbiome, metabolome and sPTB in a well phenotyped multiple pregnancy population. Furthermore, this study will utilise the unique cohort of multiple pregnancies by collecting blood samples and cervical stiffness measurements for future exploratory analysis, ultimately aiming to develop a successful risk stratification model for multiple pregnancies.
RESEARCH QUESTION/AIM(S)
To assess the vaginal microbiome in multiple pregnancies compared to low and high-risk singleton pregnancies and to evaluate associations between the vaginal microbiome, vaginal metabolome and sPTB.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Twin pregnancy
- •Able to provide informed consent
排除标准
- •Known or suspected severe structural/chromosomal fetal abnormality
- •Non-English speaking
结局指标
主要结局
The primary outcome will be spontaneous preterm birth (sPTB) <34 weeks' gestation.
时间窗: Women will be recruited at 16 weeks gestation, followed up at 28 weeks gestation and time of delivery. The primary outcome will be assessed once the participant has delivered, no later than 38 weeks gestation in a multiple pregnancy.
We will define sPTB as labour having occurred prior to 34+0 weeks of gestation in patients with either intact membranes or premature prelabour rupture of membranes (PPROM) (\<37 weeks). This excludes iatrogenic causes for preterm delivery including induction of labour (in the absence of PPROM) or elective C/S.
次要结局
未报告次要终点