Molecular Signature of Karen and Burmese Pregnant Women on the Thailand-Myanmar Border
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR
研究概览
简要总结
The primary goal of the study is to identify biomarkers from the molecular signature predictive of pre-term birth. This will be achieved through high frequency sampling and profiling throughout pregnancy.
详细描述
BACKGROUND Preterm birth occurs before 37 weeks and is a major cause of neonatal mortality and morbidity, and affecting 8% of newborns on the Thailand-Myanmar border. Identifying biochemical markers that are associated with preterm birth can guide in designing the most effective targeted intervention strategies for women at risk.
In order to identify biomarkers signatures predictive of preterm birth the investigators will employ high throughput profiling technologies (aka "a systems approach") that maximize the amount of information that can be obtained and knowledge generated from each participant sample. Preliminary data will also be obtained for infectious complications in order to assess potential for a systems approach such approach in detecting infectious events before onset of clinical symptoms or in absence of clinical symptoms. The rationale behind such approach and its importance for establishing personalized medicine approaches was detailed in a recent opinion article published. In addition parallel studies will be carried out in other countries such as Qatar and the US in order to assess environmental influences on blood and transcriptome signatures.
RESEARCH DESIGN This is a prospective pregnancy cohort from the first trimester until post-partum. The investigators are unable to predict which women will have preterm birth or infection.
STUDY POPULATION 400 Pregnant women with confirmed viable pregnancy of more than 8+0 weeks and less than 14 weeks of pregnancy, who are healthy, intend to deliver at SMRU and can attend for two weekly ANC visits.
METHOD AND TECHNIQUE
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman is willing and able to give informed consent for participation in the study.
- •Karen or Burmese, age 18-49 years
- •Healthy women with viable singleton first trimester (8+0 to < 14 weeks) pregnancy
- •Plan to delivery at SMRU clinic
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
排除标准
- •The participant will not enter the study or continue in the study if ANY of the following apply:
- •Emergency obstetric care required
- •Pregnant woman (in the investigator's opinion) with medical or obstetrics complications which would make it difficult to comply with study requirements
结局指标
主要结局
Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR
时间窗: up to 6 weeks post-partum
次要结局
- Pain scores of the different samples from pregnant women.(up to 6 weeks post-partum)
- Proportion of rate of drop-out from sampling(up to delivery)
- Molecular signature in relation to infection during pregnancy defined by real-time PCR(up to delivery)
- Molecular signature across the duration of pregnancy and post-partum time defined by real-time PCR(From enrolment at 8-14 weeks of pregnancy to 4-6 weeks post-partum)
- Proportion of women who completed two weekly sampling(up to delivery)