Molecular Signature Pregnancy

Pregnancy Clinical Trial

— MSP  

Official title:

Molecular Signature of Karen and Burmese Pregnant Women on the Thailand-Myanmar Border

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797327
• Other study ID #: SMRU1502
• Status: Completed
• Start date: September 12, 2016
• Est. completion date: January 30, 2023

Study information

• Verified date: October 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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];

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
Thailand	Shoklo Malaria Research Unit	Mae Sot	Tak

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Sidra Medical and Research Center

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR		up to 6 weeks post-partum
Secondary	Proportion of women who completed two weekly sampling		up to delivery
Secondary	Proportion of rate of drop-out from sampling		up to delivery
Secondary	Pain scores of the different samples from pregnant women.		up to 6 weeks post-partum
Secondary	Molecular signature in relation to infection during pregnancy defined by real-time PCR		up to delivery
Secondary	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