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Molecular Signature Pregnancy (MSP)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by University of Oxford
Sponsor:
Collaborator:
Sidra Medical and Research Center
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT02797327
First received: May 4, 2016
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
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.

Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Signature of Karen and Burmese Pregnant Women on the Thailand-Myanmar Border

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR [ Time Frame: up to 6 weeks post-partum ]

Secondary Outcome Measures:
  • 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
Blood sample, vaginal swab and stool specimen will be collected.

Estimated Enrollment: 400
Actual Study Start Date: September 2016
Estimated Study Completion Date: September 2018
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
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 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:

    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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02797327

Contacts
Contact: Rose McGready, MD, PhD +66 55 545021 rose@shoklo-unit.com
Contact: Francois Nosten, MD, PhD +(66) 55545021 francois@tropmedres.ac

Locations
Thailand
Shoklo Malaria Research Unit Recruiting
Mae Sot, Tak, Thailand, 63110
Contact: Rose McGready, MD,PhD    +66 55 545021    rose@shoklo-unit.com   
Contact: Francois Nosten, MD,PhD    +(66) 55545021    francois@tropmedres.ac   
Sponsors and Collaborators
University of Oxford
Sidra Medical and Research Center
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02797327     History of Changes
Other Study ID Numbers: SMRU1502
Study First Received: May 4, 2016
Last Updated: June 7, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by University of Oxford:
Molecular signature
Thailand-Myanmar border

ClinicalTrials.gov processed this record on June 26, 2017