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Active, Not Recruiting

NCT Number: NCT03531658

Singapore PREconception Study of Long-Term Maternal and Child Outcomes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

of Mother Participants:

  • 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

Exclusion criteria

of Mother Participants:

  • 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
  • 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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Duration of gestation

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

  2. Fetal growth measured by ultrasound scan

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

  3. Offspring body weight measured by calibrated weighing scale

    Time frame: From birth until 10 years of age

  4. Offspring pubertal assessment

    Time frame: From 7 until 10 years of age

    Pubertal assessment by Tanner staging

  5. Offspring growth trajectories

    Time frame: From birth until 10 years of age

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

    Time frame: From birth until 10 years of age

  7. Offspring anogenital distance measured by Vernier calipers

    Time frame: Up to 12 months, from birth until 12 months of age

  8. 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

  9. Offspring skin microbiome collected by sterile tape strips

    Time frame: 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

    Time frame: From birth until 24 months of age

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

    Time frame: From birth until 6 years of age

  12. Offspring gut microbiome measured through stool samples

    Time frame: From birth until 10 years of age

  13. 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

  14. Maternal weight measured by calibrated weighing scale

    Time frame: Between preconception, pregnancy and 10 years postpartum

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

    Time frame: Between preconception, pregnancy and 10 years postpartum

  16. 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

  17. 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

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

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

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

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

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

    Time frame: Between preconception, pregnancy and 10 years postpartum

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

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

  22. Maternal skin microbiome collected by sterile tape strips

    Time frame: 34-36 weeks of gestation and 18 months postpartum

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

    Time frame: Between preconception, pregnancy and 10 years postpartum

  24. Mode of delivery

    Time frame: Delivery

  25. Pregnancy complications obtained from questionnaires and clinical documents

    Time frame: Up to 41 weeks, between early pregnancy and delivery

  26. 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)

  27. Pregnancy and live birth rates based on ultrasound scan

    Time frame: Between early pregnancy and delivery

  28. 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

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

    Time frame: From preconception to pregnancy and up to 10 years postpartum

  30. Maternal transcription profile measured from blood samples

    Time frame: From preconception to pregnancy and up to 10 years postpartum

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

    Time frame: From preconception to pregnancy and up to 10 years postpartum

  32. Maternal micronutrient status measured from blood samples

    Time frame: 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

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

  34. Breast milk macronutrient profile

    Time frame: Up to 6 months, from 1 week to 6 months postpartum

  35. Breast milk micronutrient profile

    Time frame: Up to 6 months, from 1 week to 6 months postpartum

  36. Breast milk metabolomic profile

    Time frame: Up to 6 months, from 1 week to 6 months postpartum

  37. Breast milk epigenetic profile

    Time frame: Up to 6 months, from 1 week to 6 months postpartum

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

    Time frame: 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

    Time frame: Between preconception, pregnancy and 10 years postpartum

Other outcomes

  1. Offspring health obtained from questionnaires and clinical documents

    Time frame: From birth until 10 years of age

  2. Maternal health obtained from questionnaires and clinical documents

    Time frame: Between preconception, pregnancy and 10 years postpartum

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Institute for Human Development and Potential (IHDP), Singapore
  • National University Health System, Singapore

Registry information

Official study title

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

Acronym: S-PRESTO

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
May 22, 2018
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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