KK Women's and Children's Hospital
Singapore
NCT Number: NCT03531658
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.
This study is active but is not currently recruiting participants.
All sexes
Observational
Singapore
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
of Mother Participants:
Exclusion criteria
of Mother Participants:
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.
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).
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.
Time frame: Up to 42 weeks, between estimated date of conception based on ultrasound scan and date of delivery
Time frame: Up to 30 weeks, between 6-36 weeks of gestation
Time frame: From birth until 10 years of age
Time frame: From 7 until 10 years of age
Pubertal assessment by Tanner staging
Time frame: From birth until 10 years of age
Time frame: From birth until 10 years of age
Time frame: Up to 12 months, from birth until 12 months of age
Time frame: Up to 60 months, from 1 week until 5 years of age
Time frame: Up to 60 months, from 1 week until 5 years of age
Time frame: From birth until 24 months of age
Time frame: From birth until 6 years of age
Time frame: From birth until 10 years of age
Time frame: At preconception, 27-28 weeks of gestation, 3 months and 2, 3, 4, 6, 8, 10 years postpartum
Time frame: Between preconception, pregnancy and 10 years postpartum
Time frame: Between preconception, pregnancy and 10 years postpartum
Time frame: At preconception visit; 3 months-10 years postpartum
Time frame: Up to 123 months, between preconception, pregnancy (only using skinfold caliper) and 10 years postpartum
Time frame: Up to 123 months, between preconception, pregnancy and 10 years postpartum
Time frame: At preconception, 27-28 weeks of gestation, 6 months postpartum
Time frame: Between preconception, pregnancy and 10 years postpartum
Time frame: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Time frame: 34-36 weeks of gestation and 18 months postpartum
Time frame: Between preconception, pregnancy and 10 years postpartum
Time frame: Delivery
Time frame: Up to 41 weeks, between early pregnancy and delivery
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)
Time frame: Between early pregnancy and delivery
Time frame: From preconception to pregnancy and up to 10 years postpartum
Time frame: From preconception to pregnancy and up to 10 years postpartum
Time frame: From preconception to pregnancy and up to 10 years postpartum
Time frame: From preconception to pregnancy and up to 10 years postpartum
Time frame: From preconception to pregnancy and up to 10 years postpartum
Time frame: Up to 24 months, preconception, to pregnancy, pre-delivery and 6 weeks postpartum
Time frame: Up to 6 months, from 1 week to 6 months postpartum
Time frame: Up to 6 months, from 1 week to 6 months postpartum
Time frame: Up to 6 months, from 1 week to 6 months postpartum
Time frame: Up to 6 months, from 1 week to 6 months postpartum
Time frame: Up to 28 months, between preconception, pregnancy and 6 months postpartum
Time frame: Between preconception, pregnancy and 10 years postpartum
Time frame: From birth until 10 years of age
Time frame: Between preconception, pregnancy and 10 years postpartum
KK Women's and Children's Hospital
Other Gov
Singapore PREconception Study of Long-Term Maternal and Child Outcomes (S-PRESTO)
Acronym: S-PRESTO
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