Molecular Signature Pregnancy (MSP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02797327|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 8, 2017
|Condition or disease|
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 by Dr Chaussabel et al (2015) A vision and a prescription for big data-enabled medicine. Nat Immunol 16: 435-439. 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:
- 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.
- A stool sample will be collected and stored at -80°C. This will be collected each trimester, delivery and post-partum.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Molecular Signature of Karen and Burmese Pregnant Women on the Thailand-Myanmar Border|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||September 2018|
- Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR [ Time Frame: up to 6 weeks post-partum ]
- Proportion of women who completed two weekly sampling [ Time Frame: up to delivery ]
- Proportion of rate of drop-out from sampling [ Time Frame: up to delivery ]
- Pain scores of the different samples from pregnant women. [ Time Frame: up to 6 weeks post-partum ]
- Molecular signature in relation to infection during pregnancy defined by real-time PCR [ Time Frame: up to delivery ]
- Molecular signature across the duration of pregnancy and post-partum time defined by real-time PCR [ Time Frame: From enrolment at 8-14 weeks of pregnancy to 4-6 weeks post-partum ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797327
|Contact: Rose McGready, MD, PhD||+66 55 firstname.lastname@example.org|
|Contact: Francois Nosten, MD, PhD||+(66) email@example.com|
|Shoklo Malaria Research Unit||Recruiting|
|Mae Sot, Tak, Thailand, 63110|
|Contact: Rose McGready, MD,PhD +66 55 545021 firstname.lastname@example.org|
|Contact: Francois Nosten, MD,PhD +(66) 55545021 email@example.com|