AzTrials
AzTrials

Metabolic DiseaseS-PRESTONCT03531658

Singapore PREconception Study of Long-Term Maternal and Child Outcomes

An observational study of Metabolic Disease and Neurological and Mental Health Conditions, run by KK Women's and Children's Hospital at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

We aim to test the following primary hypothesis that nutrition, lifestyle, and maternal emotional health prior to pregnancy and/or during the first trimester alter the expression of metabolic or neurodevelopmental endophenotypes with accompanying effects on the epigenome/transcriptome of the offspring. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
1,054 participants
Where
1 siteSingapore
Study dates
27 Feb 2015to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Healthy women aged between 18 and 35 who are actively planning to conceive within a 1-year time frame upon recruitment, and later along with their children born from the indexed pregnancy.

Who may be able to join

  • Women aged 18-35 years
  • Intention to reside in Singapore for the next 5 years
  • Chinese, Malay, Indian or any combinations of these 3 ethnic groups
  • Planning to conceive within 1 year
  • Able to provide written, informed consent

Who cannot join

  • Have been actively trying to conceive for more than 18 months
  • Currently pregnant
  • Assisted fertility, apart from those taking clomiphene alone in the past 1 month
  • Established pre-existing diabetes (type 1 or type 2)
  • Oral or implanted contraception, or with an IUCD in situ in the past 1 month
  • On systemic steroids in the past 1 month
Show all 12Show fewer
  • On anticonvulsants in the past 1 month
  • On HIV or Hepatitis B or C medication in the past 1 month
  • Not becoming pregnant after more than 12 months from recruitment
  • Eventual multiple pregnancies
  • Pregnancy complications such as miscarriages, ectopic pregnancy, still birth
  • The partners of the women will also be invited to participate in the study. Babies born from these mothers will be followed up until the child is 9 years of age.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore

Other trials in Singapore

About this study

Official title: Singapore PREconception Study of Long-Term Maternal and Child Outcomes (S-PRESTO)

We aim to test the following primary hypothesis that nutrition, lifestyle, and maternal emotional health prior to pregnancy and/or during the first trimester alter the expression of metabolic or neurodevelopmental endophenotypes with accompanying effects on the epigenome/transcriptome of the offspring.

Read the detailed description

It is now evident that prenatal stage represents a window of susceptibility for early life exposure that can have an effect on developing fetus, with potential long-lasting consequences for offspring growth and development. Emerging research suggest that the environmental modulation of tissue development and function may even occur both before and soon after conception but as yet, limited study has been conducted to investigate the relationship of preconception and early prenatal life conditions, including nutrition, lifestyle and environmental factors, with maternal and offspring health.

This prospective preconception cohort study recruited 1054 women who plan to get pregnant. The investigators will assess the women metabolically, nutritionally and epigenetically, then monitor them from their first missed menses with nutritional surveys and assays and repeated bio-sampling to birth followed by assessment in the women of lactation and lactational nutrition. Biochemical and molecular analyses will be done on the cord and placenta at birth and in buccal smears at frequent postnatal intervals. The women's partners will also be recruited on consent. Phenotypic measures of body composition and core neurodevelopmental measures will be followed in the offspring from birth until 10 years of age. Metabolic and mental health of women will also be measured from preconception until 10 years postpartum. At delivery phase, there are 373 mother-child pairs with 80% of fathers enrolled in the study as well.

This study allows understanding of the potential triggers during early life environment, including nutritional and lifestyle factors, emotional wellbeing, socio-economic status, microbiome, pollutants, metabolomics and epigenetics, which can independently or collectively influence metabolic and neural phenotypes in the offspring and mother. This will help to establish what future directions may hold in terms of possible preventive strategies that may lead to decreased prevalence of metabolic diseases and mental/ neurological disorders.

Keywords
Cohort Study, Birth Cohort, Longitudinal Study, Pregnancy, Growth, Developmental Origins of Health and Disease, DOHaD, Epidemiology, Maternal Health, Infant Health, Child Health, Health Outcomes, Postnatal Exposure, Perinatal Exposure, Environmental Factors, Nutrition, Genetics
Medical subject headings
Metabolic Diseases, Neurologic Manifestations, Genetic Predisposition to Disease, Skin Diseases, Developmental Origins of Health and Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Offspring adiposity

    Offspring adiposity (total and percentage fat mass) measured by skinfold calipers, air-displacement plethysmography, quantitative magnetic resonance (QMR), Bioelectrical Impedance Analysis (BIA), and Magnetic resonance imaging (MRI).

    Measured: From birth until 10 years of age

  2. Offspring neurocognitive and behavioural development

    Offspring neurocognitive and behavioural development measured by questionnaires, behavioural tasks and brain MRI.

    Measured: From 3-12 months up till 10 years of age

Secondary outcomes (39)

  1. Duration of gestation

    Measured: Up to 42 weeks, between estimated date of conception based on ultrasound scan and date of delivery

  2. Fetal growth measured by ultrasound scan

    Measured: Up to 30 weeks, between 6-36 weeks of gestation

  3. Offspring body weight measured by calibrated weighing scale

    Measured: From birth until 10 years of age

  4. Offspring pubertal assessment

    Pubertal assessment by Tanner staging

    Measured: From 7 until 10 years of age

  5. Offspring growth trajectories

    Measured: From birth until 10 years of age

  6. Offspring adiposity trajectories (total and percentage fat mass)

    Measured: From birth until 10 years of age

  7. Offspring anogenital distance measured by Vernier calipers

    Measured: Up to 12 months, from birth until 12 months of age

  8. Offspring allergic wellbeing measured by skin examination and skin prick test

    Measured: Up to 60 months, from 1 week until 5 years of age

  9. Offspring skin microbiome collected by sterile tape strips

    Measured: Up to 60 months, from 1 week until 5 years of age

  10. Offspring metabolomics, lipidomics and pollutant profile measured through biospecimens such as cord, cord blood, heel prick blood, and hair samples

    Measured: From birth until 24 months of age

  11. Offspring epigenetic profile measured through cord, cord blood, and buccal smear samples

    Measured: From birth until 6 years of age

  12. Offspring gut microbiome measured through stool samples

    Measured: From birth until 10 years of age

  13. Maternal glucose tolerance status measured by Oral Glucose Tolerance Test (OGTT)

    Measured: At preconception, 27-28 weeks of gestation, 3 months and 2, 3, 4, 6, 8, 10 years postpartum

  14. Maternal weight measured by calibrated weighing scale

    Measured: Between preconception, pregnancy and 10 years postpartum

  15. Changes in maternal weight before, during and after gestation

    Measured: Between preconception, pregnancy and 10 years postpartum

  16. Maternal body weight status determined by body mass index based on weight (kg) /height (m)2

    Measured: At preconception visit; 3 months-10 years postpartum

  17. Maternal body composition measured by skinfold calipers, air-displacement plethysmography, bioelectrical impedance analysis and dual-energy X-ray absorptiometry (DXA)

    Measured: Up to 123 months, between preconception, pregnancy (only using skinfold caliper) and 10 years postpartum

  18. Changes in maternal body composition before, during and after gestation

    Measured: Up to 123 months, between preconception, pregnancy and 10 years postpartum

  19. Maternal cardiovascular health (subsample) measured through clinical examination

    Measured: At preconception, 27-28 weeks of gestation, 6 months postpartum

  20. Maternal blood pressure measured by semi-automatic blood pressure device

    Measured: Between preconception, pregnancy and 10 years postpartum

  21. Maternal allergic wellbeing measured by questionnaires and skin prick test

    Measured: Up to 40 months, between preconception, pregnancy and 18 months postpartum

  22. Maternal skin microbiome collected by sterile tape strips

    Measured: 34-36 weeks of gestation and 18 months postpartum

  23. Maternal mental health/emotional wellbeing measured by questionnaires and behavioural tasks

    Measured: Between preconception, pregnancy and 10 years postpartum

  24. Mode of delivery

    Measured: Delivery

  25. Pregnancy complications obtained from questionnaires and clinical documents

    Measured: Up to 41 weeks, between early pregnancy and delivery

  26. Time to pregnancy

    Measured: Up to 12 months, between the date of last menstrual period obtained from the first preconception visit and before conception (if pregnant) or the most recent follow up (if not pregnant)

  27. Pregnancy and live birth rates based on ultrasound scan

    Measured: Between early pregnancy and delivery

  28. Maternal metabolomics, lipidomics and pollutant profile measured from biospecimens such as blood, urine, hair

    Measured: From preconception to pregnancy and up to 10 years postpartum

  29. Maternal epigenetic profile measured from blood and buccal smear samples

    Measured: From preconception to pregnancy and up to 10 years postpartum

  30. Maternal transcription profile measured from blood samples

    Measured: From preconception to pregnancy and up to 10 years postpartum

  31. Maternal, paternal and offspring genotyping (blood or buccal samples)

    Measured: From preconception to pregnancy and up to 10 years postpartum

  32. Maternal micronutrient status measured from blood samples

    Measured: From preconception to pregnancy and up to 10 years postpartum

  33. Maternal microbiota composition profile measured from stool and epithelial (breast, vaginal and rectal) swab samples

    Measured: Up to 24 months, preconception, to pregnancy, pre-delivery and 6 weeks postpartum

  34. Breast milk macronutrient profile

    Measured: Up to 6 months, from 1 week to 6 months postpartum

  35. Breast milk micronutrient profile

    Measured: Up to 6 months, from 1 week to 6 months postpartum

  36. Breast milk metabolomic profile

    Measured: Up to 6 months, from 1 week to 6 months postpartum

  37. Breast milk epigenetic profile

    Measured: Up to 6 months, from 1 week to 6 months postpartum

  38. Maternal and infant transcriptomics (including of breast milk)

    Measured: Up to 28 months, between preconception, pregnancy and 6 months postpartum

  39. Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes

    Measured: Between preconception, pregnancy and 10 years postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start27 Feb 2015
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
1,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531658
Sponsor's protocol ID
2019/2143/D
Other IDs
NMRC/TCR/012-NUHS/2014, MOH-000504
Acronym
S-PRESTO
Status last verified
May 2026
First submitted
27 Aug 2017
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loo EXL, Soh SE, Loy SL, Ng S, Tint MT, Chan SY, Huang JY, Yap F, Tan KH, Chern BSM, Tan HH, Meaney MJ, Karnani N, Godfrey KM, Lee YS, Chan JKY, Gluckman PD, Chong YS, Shek LP, Eriksson JG; S-PRESTO Study Group; Chia A, Fogel AM, Goh AEN, Chu AHY, Rifkin-Graboi A, Qiu A, Lee BW, Cheon BK, Vaz C, Henry CJ, Forde CG, Chi C, Koh DXP, Phua DY, Loh DNL, Quah EPL, Tham EH, Law ECN, Magkos F, Mueller-Riemenschneider F, Yeo GSH, Yong HEJ, Chen HY, Tan HH, Pan H, Bever HPSV, Tan HM, Aris IBM, Tay J, Chan JKY, Xu J, Yoong JS, Eriksson JG, Choo JTL, Bernard JY, Huang JY, Lai JS, Tan KML, Godfrey KM, Kwek KYC, McCrickerd K, Narasimhan K, Chong KW, Lee KJ, Chen L, Ling LH, Chen LW, Daniel LM, Shek LP, Fortier MV, Chong MF, Chua MC, Leow MK, Kee MZL, Gong M, Tint MT, Michael N, Lek N, Teoh OH, Mishra P, Li QLJ, Velan SS, Ang SB, Cai S, Goh SH, Lim SB, Tsotsi S, Hsu SC, Toh SES, Sadananthan SA, Tan TH, Yew TW, Gupta V, Rajadurai VS, Han WM, Pang WW, Yuan WL, Zhu Y, Cheung YB, Chan YH, Cheng ZR. Cohort profile: Singapore Preconception Study of Long-Term Maternal and Child Outcomes (S-PRESTO). Eur J Epidemiol. 2021 Jan;36(1):129-142. doi: 10.1007/s10654-020-00697-2. Epub 2020 Nov 21.

    PubMed 33222050

  • Ng DZW, Yap GC, Tay CJX, Huang CH, Zhao S, Low A, Tham EH, Loo EXL, Shek LP, Goh A, Chong KW, Goh SH, Cheng ZR, Van Bever HPS, Teoh OH, Lee YS, Yap F, Tan KH, Chong YS, Chan SY, Eriksson JG, Godfrey KM, Lay C, Knol J, Schuster SC, Lai JS, Chong MF, Lee JWJ, Lee BW, Chan ECY, Ta LDH. Maternal-prenatal gut microbiome-systemic metabolome perturbations and TH2-skewed immunity link to offspring gut microbiome disruption and atopic dermatitis susceptibility. Genome Med. 2026 Apr 17;18(1):72. doi: 10.1186/s13073-026-01655-5.

    PubMed 41998770

  • Chu AHY, Padmapriya N, Tan SL, Goh CMJL, Chong YS, Shek LP, Tan KH, Gluckman PD, Yap FKP, Lee YS, Loy SL, Chan JKY, Godfrey KM, Eriksson JG, Chan SY, Bernard JY, Muller-Riemenschneider F. Preconception to postpartum accelerometry-based 24-hour movement behaviors: a prospective cohort study. BMC Public Health. 2026 Jan 7;26(1):465. doi: 10.1186/s12889-025-26034-4.

    PubMed 41501702

  • Ku CW, Chan HG, Sia AL, Huang C, Quek J, Cheung YB, Tan KML, Lai JS, Godfrey KM, Chan JKY, Yap F, Loy SL. One-carbon metabolism, insulin resistance, and fecundability in a Singapore prospective preconception cohort study. Am J Clin Nutr. 2025 Jul;122(1):335-343. doi: 10.1016/j.ajcnut.2025.04.035. Epub 2025 May 5.

    PubMed 40334751

  • Chen L, Mir SA, Bendt AK, Chua EWL, Narasimhan K, Tan KM, Loy SL, Tan KH, Shek LP, Chan J, Yap F, Meaney MJ, Chan SY, Chong YS, Gluckman PD, Eriksson JG, Karnani N, Wenk MR. Plasma lipidomic profiling reveals metabolic adaptations to pregnancy and signatures of cardiometabolic risk: a preconception and longitudinal cohort study. BMC Med. 2023 Feb 13;21(1):53. doi: 10.1186/s12916-023-02740-x.

    PubMed 36782297

  • Li LJ, Du R, Loy SL, Chong YS, Chan JKY, Wong TY, Eriksson JG, Huang Z, Zhang C. Retinal microvasculature and risk of spontaneous abortion in multiethnic Southeast Asian women. Fertil Steril. 2022 Oct;118(4):748-757. doi: 10.1016/j.fertnstert.2022.06.033. Epub 2022 Aug 16.

    PubMed 35981917

  • Lim SX, Loy SL, Colega MT, Lai JS, Godfrey KM, Lee YS, Tan KH, Yap F, Shek LP, Chong YS, Eriksson JG, Chan JKY, Chan SY, Chong MF. Prepregnancy adherence to plant-based diet indices and exploratory dietary patterns in relation to fecundability. Am J Clin Nutr. 2022 Feb 9;115(2):559-569. doi: 10.1093/ajcn/nqab344.

    PubMed 34626169

  • Huang L, Loy SL, Chen WQ, Eriksson JG, Chong YS, Huang Z, Chan JKY, Wong TY, Kramer M, Zhang C, Li LJ. Retinal microvasculature and time to pregnancy in a multi-ethnic pre-conception cohort in Singapore. Hum Reprod. 2021 Oct 18;36(11):2935-2947. doi: 10.1093/humrep/deab197.

    PubMed 34492112

  • Lim SX, Colega MT, M Ayob MN, Robinson SM, Godfrey KM, Bernard JY, Lee YS, Tan KH, Yap F, Shek LP, Chong YS, Eriksson JG, Chan JK, Chan SY, Chong MF. Identification and reproducibility of dietary patterns assessed with a FFQ among women planning pregnancy. Public Health Nutr. 2021 Jun;24(9):2437-2446. doi: 10.1017/S1368980021001178. Epub 2021 Mar 22.

    PubMed 33745499

  • Loy SL, Ku CW, Lai AEQ, Choo XH, Ho AHM, Cheung YB, Godfrey KM, Chong YS, Gluckman PD, Shek LP, Tan KH, Yap FKP, Chan SY, Chan JKY. Plasma glycemic measures and fecundability in a Singapore preconception cohort study. Fertil Steril. 2021 Jan;115(1):138-147. doi: 10.1016/j.fertnstert.2020.07.014. Epub 2020 Oct 15.

    PubMed 33070964

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Disease and Neurological and Mental Health Conditions, run by KK Women's and Children's Hospital at 1 site in Singapore.

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 12 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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 Singapore. 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?

This study is still under way. Results are not available in the source record yet.

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?

Offspring adiposity (time frame: From birth until 10 years of age). The study lists 2 primary outcomes in all. 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 NCT03531658, which also lists 10 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 26 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in