Molecular Signature Pregnancy
Condition: Pregnancy
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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

        -  Pregnant women attending SMRU ANC clinics will be invited to participate in the study.

        -  Study samples will include:

             1. A small blood volume (100 micro litres) will be collected by finger prick sampling
                via a capillary straw. The sample will be transferred into a microtube containing
                an RNA stabilizing solution and stored at -80°C. This will be repeated every two
                weeks, delivery and post-partum.

             2. A stool sample will be collected and stored at -80°C. This will be collected each
                trimester, delivery and post-partum.

             3. A vaginal swab will be collected from the posterior fornix under direct
                visualization by the midwife; and stored at -80°C. This will be collected each
                trimester, delivery and post-partum.

      The post-partum visits, will be at 4-6 weeks and at 3months. The investigators estimate 15-18
      blood samples, and 6 stool and vaginal swabs will be collected per women if they attend as
      expected. Fetal growth will be measured by 5-6 weekly ultrasound scans.

      The sample set will be repeated if the woman has fever during pregnancy or post-partum
      (estimated at 5% of the women).

      POTENTIAL VALUE Identifying biochemical markers that are associated with preterm can guide in
      designing the most effective targeted intervention strategies aimed at women at risk for
      preterm birth.

      Funder & grant reference number: Sidra Medical and Research Center (Sidra)/ B9R01250; and
      supported by Wellcome [220211; assigned to Nicholas Day];
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Target population: First trimester pregnant women with a viable pregnancy who will be
        followed for the outcome of interest of preterm births on the Thailand-Myanmar border
      
Biospecimen description: 
      Blood sample, vaginal swab and stool specimen will be collected.
    
Keywords: Molecular signature; Thailand-Myanmar border