NCT02797327

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6.4 years

First QC Date

May 4, 2016

Last Update Submit

October 16, 2023

Conditions

Pregnancy

Keywords

Molecular signatureThailand-Myanmar border

Outcome Measures

Primary Outcomes (1)

  • Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR

    up to 6 weeks post-partum

Secondary Outcomes (5)

  • Proportion of women who completed two weekly sampling

    up to delivery

  • Proportion of rate of drop-out from sampling

    up to delivery

  • Pain scores of the different samples from pregnant women.

    up to 6 weeks post-partum

  • Molecular signature in relation to infection during pregnancy defined by real-time PCR

    up to delivery

  • 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

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

Related Publications (3)

  • Ahmad F, Lakshmanan AP, Alabduljabbar S, Ahmed SH, Ahmed A, Kabeer BSA, Marr AK, Kino T, Brummaier T, McGready R, Nosten F, Chaussabel D, Al Khodor S, Terranegra A. Placental and cord blood DNA methylation in preterm birth: exploring the epigenetic role of maternal dietary protein. NPJ Sci Food. 2025 Oct 14;9(1):206. doi: 10.1038/s41538-025-00566-w.

    PMID: 41087373DERIVED

  • Brummaier T, Syed Ahamed Kabeer B, Wilaisrisak P, Pimanpanarak M, Win AK, Pukrittayakamee S, Marr AK, Kino T, Al Khodor S, Terranegra A, Carrara VI, Nosten F, Utzinger J, Chaussabel D, Paris DH, McGready R. Cohort profile: molecular signature in pregnancy (MSP): longitudinal high-frequency sampling to characterise cross-omic trajectories in pregnancy in a resource-constrained setting. BMJ Open. 2020 Oct 10;10(10):e041631. doi: 10.1136/bmjopen-2020-041631.

    PMID: 33040018DERIVED

  • Brummaier T, Syed Ahamed Kabeer B, Lindow S, Konje JC, Pukrittayaamee S, Utzinger J, Toufiq M, Antoniou A, Marr AK, Suriyakan S, Kino T, Al Khodor S, Terranegra A, Nosten F, Paris DH, McGready R, Chaussabel D. A prospective cohort for the investigation of alteration in temporal transcriptional and microbiome trajectories preceding preterm birth: a study protocol. BMJ Open. 2019 Jan 15;9(1):e023417. doi: 10.1136/bmjopen-2018-023417.

    PMID: 30782707DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, vaginal swab and stool specimen will be collected.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

June 13, 2016

Study Start

September 12, 2016

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Locations

TH(1)