PregnancyMSPNCT02797327
Molecular Signature Pregnancy
An observational study of Pregnancy, run by University of Oxford at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 430 participants
- Where
- 1 siteThailand
- Study dates
- 12 Sep 2016to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Signature of Karen and Burmese Pregnant Women on the Thailand-Myanmar Border
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.
Read the 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. 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.
Funder \& grant reference number: Sidra Medical and Research Center (Sidra)/ B9R01250; and supported by Wellcome [220211; assigned to Nicholas Day];
- Conditions
- Pregnancy
- Keywords
- Molecular signature, Thailand-Myanmar border
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR
Measured: up to 6 weeks post-partum
Secondary outcomes (5)
Proportion of women who completed two weekly sampling
Measured: up to delivery
Proportion of rate of drop-out from sampling
Measured: up to delivery
Pain scores of the different samples from pregnant women.
Measured: up to 6 weeks post-partum
Molecular signature in relation to infection during pregnancy defined by real-time PCR
Measured: up to delivery
Molecular signature across the duration of pregnancy and post-partum time defined by real-time PCR
Measured: From enrolment at 8-14 weeks of pregnancy to 4-6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start12 Sep 2016
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Sidra Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797327
- Sponsor's protocol ID
- SMRU1502
- Acronym
- MSP
- Status last verified
- Oct 2023
- First submitted
- 4 May 2016
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 41087373Brummaier 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.
PubMed 33040018Brummaier 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.
PubMed 30782707
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Signature of Karen and Burmese Pregnant Women on the Thailand-Myanmar Border
- ClinicalTrials.gov ID
- NCT02797327
- Acronym / sponsor ID
- MSP / SMRU1502
- Conditions
- Pregnancy
- Keywords
- Molecular signature, Thailand-Myanmar border
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Sidra Medicine
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Funder \& grant reference number: Sidra Medical and Research Center (Sidra)/ B9R01250; and supported by Wellcome [220211; assigned to Nicholas Day];
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR
Time frame: up to 6 weeks post-partum
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 41087373Ahmad 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.
- Derived from this study: PubMed 33040018Brummaier 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.
- Derived from this study: PubMed 30782707Brummaier 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the molecular signature of 30 preterm pregnancies defined by real-time PCR (time frame: up to 6 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02797327, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.