Singapore PREconception Study of Long-Term Maternal and Child Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1054 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-27

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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 9 years of age. Metabolic and mental health of women will also be measured from preconception until 9 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.

Conditions

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Metabolic Disease Neurological and Mental Health Conditions Genetics Predisposition Skin Condition Environmental Exposure Socioeconomic Factors Psychology, Social

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes