Molecular Signature Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-12

Study Completion Date

2023-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers

NCT02808494

Preeclampsia

COMPLETED

Development of a Non-invasive Prenatal Test

NCT01451684

Pregnancy

COMPLETED

Development of a Prenatal Test for Fetal Aneuploidy Detection

NCT01451671

Fetal Complications

COMPLETED

Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia

NCT03903393

Preeclampsia

UNKNOWN

Measuring hCG Levels in Pregnant Women

NCT02763176

hCG

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 \[220211; assigned to Nicholas Day\];

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes