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

May 21, 2026 updated by: Jerry Chan, KK Women's and Children's Hospital

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

1054

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria of Mother Participants:

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

Exclusion Criteria of Mother Participants:

  1. Have been actively trying to conceive for more than 18 months
  2. Currently pregnant
  3. Assisted fertility, apart from those taking clomiphene alone in the past 1 month
  4. Established pre-existing diabetes (type 1 or type 2)
  5. Oral or implanted contraception, or with an IUCD in situ in the past 1 month
  6. On systemic steroids in the past 1 month
  7. On anticonvulsants in the past 1 month
  8. On HIV or Hepatitis B or C medication in the past 1 month
  9. Not becoming pregnant after more than 12 months from recruitment
  10. Eventual multiple pregnancies
  11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Offspring adiposity
Time Frame: From birth until 10 years of age
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).
From birth until 10 years of age
Offspring neurocognitive and behavioural development
Time Frame: From 3-12 months up till 10 years of age
Offspring neurocognitive and behavioural development measured by questionnaires, behavioural tasks and brain MRI.
From 3-12 months up till 10 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of gestation
Time Frame: Up to 42 weeks, between estimated date of conception based on ultrasound scan and date of delivery
Up to 42 weeks, between estimated date of conception based on ultrasound scan and date of delivery
Fetal growth measured by ultrasound scan
Time Frame: Up to 30 weeks, between 6-36 weeks of gestation
Up to 30 weeks, between 6-36 weeks of gestation
Offspring anogenital distance measured by Vernier calipers
Time Frame: Up to 12 months, from birth until 12 months of age
Up to 12 months, from birth until 12 months of age
Maternal cardiovascular health (subsample) measured through clinical examination
Time Frame: At preconception, 27-28 weeks of gestation, 6 months postpartum
At preconception, 27-28 weeks of gestation, 6 months postpartum
Maternal allergic wellbeing measured by questionnaires and skin prick test
Time Frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Up to 40 months, between preconception, pregnancy and 18 months postpartum
Maternal skin microbiome collected by sterile tape strips
Time Frame: 34-36 weeks of gestation and 18 months postpartum
34-36 weeks of gestation and 18 months postpartum
Mode of delivery
Time Frame: Delivery
Delivery
Pregnancy complications obtained from questionnaires and clinical documents
Time Frame: Up to 41 weeks, between early pregnancy and delivery
Up to 41 weeks, between early pregnancy and delivery
Time to pregnancy
Time Frame: 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)
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)
Pregnancy and live birth rates based on ultrasound scan
Time Frame: Between early pregnancy and delivery
Between early pregnancy and delivery
Maternal microbiota composition profile measured from stool and epithelial (breast, vaginal and rectal) swab samples
Time Frame: Up to 24 months, preconception, to pregnancy, pre-delivery and 6 weeks postpartum
Up to 24 months, preconception, to pregnancy, pre-delivery and 6 weeks postpartum
Breast milk macronutrient profile
Time Frame: Up to 6 months, from 1 week to 6 months postpartum
Up to 6 months, from 1 week to 6 months postpartum
Breast milk micronutrient profile
Time Frame: Up to 6 months, from 1 week to 6 months postpartum
Up to 6 months, from 1 week to 6 months postpartum
Breast milk metabolomic profile
Time Frame: Up to 6 months, from 1 week to 6 months postpartum
Up to 6 months, from 1 week to 6 months postpartum
Breast milk epigenetic profile
Time Frame: Up to 6 months, from 1 week to 6 months postpartum
Up to 6 months, from 1 week to 6 months postpartum
Maternal and infant transcriptomics (including of breast milk)
Time Frame: Up to 28 months, between preconception, pregnancy and 6 months postpartum
Up to 28 months, between preconception, pregnancy and 6 months postpartum
Offspring allergic wellbeing measured by skin examination and skin prick test
Time Frame: Up to 60 months, from 1 week until 5 years of age
Up to 60 months, from 1 week until 5 years of age
Offspring skin microbiome collected by sterile tape strips
Time Frame: Up to 60 months, from 1 week until 5 years of age
Up to 60 months, from 1 week until 5 years of age
Offspring body weight measured by calibrated weighing scale
Time Frame: From birth until 10 years of age
From birth until 10 years of age
Offspring pubertal assessment
Time Frame: From 7 until 10 years of age
Pubertal assessment by Tanner staging
From 7 until 10 years of age
Offspring growth trajectories
Time Frame: From birth until 10 years of age
From birth until 10 years of age
Offspring adiposity trajectories (total and percentage fat mass)
Time Frame: From birth until 10 years of age
From birth until 10 years of age
Offspring metabolomics, lipidomics and pollutant profile measured through biospecimens such as cord, cord blood, heel prick blood, and hair samples
Time Frame: From birth until 24 months of age
From birth until 24 months of age
Offspring epigenetic profile measured through cord, cord blood, and buccal smear samples
Time Frame: From birth until 6 years of age
From birth until 6 years of age
Offspring gut microbiome measured through stool samples
Time Frame: From birth until 10 years of age
From birth until 10 years of age
Maternal glucose tolerance status measured by Oral Glucose Tolerance Test (OGTT)
Time Frame: At preconception, 27-28 weeks of gestation, 3 months and 2, 3, 4, 6, 8, 10 years postpartum
At preconception, 27-28 weeks of gestation, 3 months and 2, 3, 4, 6, 8, 10 years postpartum
Maternal weight measured by calibrated weighing scale
Time Frame: Between preconception, pregnancy and 10 years postpartum
Between preconception, pregnancy and 10 years postpartum
Changes in maternal weight before, during and after gestation
Time Frame: Between preconception, pregnancy and 10 years postpartum
Between preconception, pregnancy and 10 years postpartum
Maternal body weight status determined by body mass index based on weight (kg) /height (m)2
Time Frame: At preconception visit; 3 months-10 years postpartum
At preconception visit; 3 months-10 years postpartum
Maternal body composition measured by skinfold calipers, air-displacement plethysmography, bioelectrical impedance analysis and dual-energy X-ray absorptiometry (DXA)
Time Frame: Up to 123 months, between preconception, pregnancy (only using skinfold caliper) and 10 years postpartum
Up to 123 months, between preconception, pregnancy (only using skinfold caliper) and 10 years postpartum
Changes in maternal body composition before, during and after gestation
Time Frame: Up to 123 months, between preconception, pregnancy and 10 years postpartum
Up to 123 months, between preconception, pregnancy and 10 years postpartum
Maternal blood pressure measured by semi-automatic blood pressure device
Time Frame: Between preconception, pregnancy and 10 years postpartum
Between preconception, pregnancy and 10 years postpartum
Maternal mental health/emotional wellbeing measured by questionnaires and behavioural tasks
Time Frame: Between preconception, pregnancy and 10 years postpartum
Between preconception, pregnancy and 10 years postpartum
Maternal metabolomics, lipidomics and pollutant profile measured from biospecimens such as blood, urine, hair
Time Frame: From preconception to pregnancy and up to 10 years postpartum
From preconception to pregnancy and up to 10 years postpartum
Maternal epigenetic profile measured from blood and buccal smear samples
Time Frame: From preconception to pregnancy and up to 10 years postpartum
From preconception to pregnancy and up to 10 years postpartum
Maternal transcription profile measured from blood samples
Time Frame: From preconception to pregnancy and up to 10 years postpartum
From preconception to pregnancy and up to 10 years postpartum
Maternal, paternal and offspring genotyping (blood or buccal samples)
Time Frame: From preconception to pregnancy and up to 10 years postpartum
From preconception to pregnancy and up to 10 years postpartum
Maternal micronutrient status measured from blood samples
Time Frame: From preconception to pregnancy and up to 10 years postpartum
From preconception to pregnancy and up to 10 years postpartum
Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes
Time Frame: Between preconception, pregnancy and 10 years postpartum
Between preconception, pregnancy and 10 years postpartum

Other Outcome Measures

Outcome Measure
Time Frame
Offspring health obtained from questionnaires and clinical documents
Time Frame: From birth until 10 years of age
From birth until 10 years of age
Maternal health obtained from questionnaires and clinical documents
Time Frame: Between preconception, pregnancy and 10 years postpartum
Between preconception, pregnancy and 10 years postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jerry Kok Yen Chan, KK Women's and Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2015

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 27, 2017

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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