Singapore PREconception Study of Long-Term Maternal and Child Outcomes

Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03531658
• Other study ID #: 2014/692/D
• Status: Active, not recruiting
• Start date: February 27, 2015
• Est. completion date: December 2026

Study information

• Verified date: January 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to evaluate how preconception and early prenatal environmental factors can potentially influence health outcomes for both mother and child during pregnancy and postnatally.

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 8 years of age. Metabolic and mental health of women will also be measured from preconception until 8 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1054
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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. Upon informed consent, fathers will have blood, urine, hair sampling, buccal swabs, body measurements and cognitive assessment. These will be done along with health and lifestyle questionnaire within one to two study visits.

The mothers will consent for their children to have body measurements, cognitive assessment, buccal, hair, stool samples and allergy testing from birth to 8 years of age. Assent will also be taken when the child turns 6.

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Neurological and Mental Health Conditions

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	National University Health System, Singapore, Singapore Institute for Clinical Sciences

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Offspring health obtained from questionnaires and clinical documents		Up to 96 months, from birth until 8 years of age
Other	Maternal health obtained from questionnaires and clinical documents		Up to 123 months, between preconception, pregnancy and 8 years postpartum
Primary	Offspring adiposity	Offspring adiposity (total and percentage fat mass) measured by skinfold calipers, air-displacement plethysmography, quantitative magnetic resonance (QMR) and Magnetic resonance imaging (MRI).	Up to 96 months, from birth until 8 years of age
Primary	Offspring neurocognitive and behavioural development	Offspring neurocognitive and behavioural development measured by questionnaires, behavioural tasks and brain MRI.	Up to 9 months, from 3-12 months of age
Secondary	Duration of gestation		Up to 42 weeks, between estimated date of conception based on ultrasound scan and date of delivery
Secondary	Fetal growth measured by ultrasound scan		Up to 30 weeks, between 6-36 weeks of gestation
Secondary	Offspring body weight measured by calibrated weighing scale		Up to 96 months, from birth until 8 years of age
Secondary	Offspring growth trajectories		Up to 96 months, from birth until 8 years of age
Secondary	Offspring adiposity trajectories (total and percentage fat mass)		Up to 96 months, from birth until 8 years of age
Secondary	Offspring anogenital distance measured by Vernier calipers		Up to 12 months, from birth until 12 months of age
Secondary	Offspring allergic wellbeing measured by skin examination and skin prick test		Up to 60 months, from 1 week until 5 years of age
Secondary	Offspring skin microbiome collected by sterile tape strips		Up to 60 months, from 1 week until 5 years of age
Secondary	Offspring metabolomics, lipidomics and pollutant profile measured through biospecimens such as cord, cord blood, heel prick blood, and hair samples		Up to 96 months, from birth until 8 years of age
Secondary	Offspring epigenetic profile measured through cord, cord blood, and buccal smear samples		Up to 96 months, from birth until 8 years of age
Secondary	Offspring gut microbiome measured through stool samples		Up to 96 months, from birth until 8 years of age
Secondary	Maternal glucose tolerance status measured by Oral Glucose Tolerance Test (OGTT)		At preconception, 27-28 weeks of gestation, 3 months and 2, 3, 4, 6, 8 years postpartum
Secondary	Maternal weight measured by calibrated weighing scale		Up to 123 months, between preconception, pregnancy and 8 years postpartum
Secondary	Changes in maternal weight before, during and after gestation		Up to 123 months, between preconception, pregnancy and 8 years postpartum
Secondary	Maternal body weight status determined by body mass index based on weight (kg) /height (m)2		At preconception visit; 3 months- 8 years postpartum
Secondary	Maternal body composition measured by skinfold calipers, air-displacement plethysmography, bioelectrical impedance analysis and dual-energy X-ray absorptiometry (DXA)		Up to 123 months, between preconception, pregnancy (only using skinfold caliper) and 8 years postpartum
Secondary	Changes in maternal body composition before, during and after gestation		Up to 123 months, between preconception, pregnancy and 8 years postpartum
Secondary	Maternal cardiovascular health (subsample) measured through clinical examination		At preconception, 27-28 weeks of gestation, 6 months postpartum
Secondary	Maternal blood pressure measured by semi-automatic blood pressure device		Up to 123 months, between preconception, pregnancy and 8 years postpartum
Secondary	Maternal allergic wellbeing measured by questionnaires and skin prick test		Up to 40 months, between preconception, pregnancy and 18 months postpartum
Secondary	Maternal skin microbiome collected by sterile tape strips		34-36 weeks of gestation and 18 months postpartum
Secondary	Maternal mental health/emotional wellbeing measured by questionnaires and behavioural tasks		Up to 123 months, between preconception, pregnancy and 8 years postpartum
Secondary	Mode of delivery		Delivery
Secondary	Pregnancy complications obtained from questionnaires and clinical documents		Up to 41 weeks, between early pregnancy and delivery
Secondary	Time to pregnancy		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)
Secondary	Pregnancy and live birth rates based on ultrasound scan		Between early pregnancy and delivery
Secondary	Maternal metabolomics, lipidomics and pollutant profile measured from biospecimens such as blood, urine, hair		Up to 123 months, from preconception to pregnancy and up to 8 years postpartum
Secondary	Maternal epigenetic profile measured from blood and buccal smear samples		Up to 123 months, from preconception to pregnancy and up to 8 years postpartum
Secondary	Maternal transcription profile measured from blood samples		Up to 123 months, from preconception to pregnancy and up to 8 years postpartum
Secondary	Maternal, paternal and offspring genotyping (blood or buccal samples)		Up to 123 months, from preconception to pregnancy and up to 8 years postpartum
Secondary	Maternal micronutrient status measured from blood samples		Up to 123 months, from preconception to pregnancy and up to 8 years postpartum
Secondary	Maternal microbiota composition profile measured from stool and epithelial (breast, vaginal and rectal) swab samples		Up to 24 months, preconception, to pregnancy, pre-delivery and 6 weeks postpartum
Secondary	Breast milk macronutrient profile		Up to 6 months, from 1 week to 6 months postpartum
Secondary	Breast milk micronutrient profile		Up to 6 months, from 1 week to 6 months postpartum
Secondary	Breast milk metabolomic profile		Up to 6 months, from 1 week to 6 months postpartum
Secondary	Breast milk epigenetic profile		Up to 6 months, from 1 week to 6 months postpartum
Secondary	Maternal and infant transcriptomics (including of breast milk)		Up to 28 months, between preconception, pregnancy and 6 months postpartum
Secondary	Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes		Up to 123 months, between preconception, pregnancy and 8 years postpartum