- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07432217
Mapping Antenatal Maternal Stress (MAMS)
Mapping Antenatal Maternal Stress (MAMS)
Study Overview
Status
Detailed Description
Prenatal maternal mental health has a significant long-lasting impact on both maternal functioning and child development. In Singapore and other developed nations, approximately 40% of pregnant women report symptoms of depression or anxiety at levels that predict poor maternal psychosocial functioning, as well as altered neurodevelopment and emotional-cognitive difficulties in their children. Despite the high prevalence and well-established consequences of prenatal mood disorders, the biological mechanisms underlying these conditions remain poorly understood. Prior research has implicated stress hormones, gonadal steroids, and genes, particularly within the serotonergic system, in contributing to perinatal depression and anxiety. However, candidate gene approaches have limitations. Mental health disorders arise from the combined effects of multiple genetic variants across distributed networks, rather than isolated loci. This understanding has led to the use of polygenic risk scores (PRS), which aggregate genetic variants associated with psychiatric conditions, to capture cumulative biological susceptibility. This MAMS study aims to build a predictive model for maternal antenatal i) anxiety, ii) depression, as well as iii) identify the genomic contribution to a composite score representing maternal mental health/well-being across a series of instruments. The research will also examine predictors of co-morbid conditions, notably depression and anxiety, where the effects on child developmental outcomes appear to be greater. Participants will be followed up from pregnancy through the child turning at least four years old. A subset of participants is enrolled in a sub-study Mapping Antenatal Maternal Stress - Child Outcomes (MAMS-CO).
Data will be collected through questionnaires done online, biological samples collection, and assessments done during lab-based visits.
- Questionnaires related to depression, anxiety, psychosocial risk factors such as life stressors, social and partner support, socioeconomic factors, medical history, behavior, cognition, lifestyle, health status, parental bonding, childhood adversity experienced, socio-emotional factors, executive function, family dynamics, sleep quality, personality traits
- Collection of samples such as blood, buccal swabs, and saliva
- Sleep actigraphy measures on pregnant mothers and infants
- Child developmental assessments
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Singapore, Singapore, 117609
- Institute for Human Development and Potential
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Mothers aged 21 - 40 years
- Below 24 weeks of pregnancy by ultrasonography
- Proficient and able to respond to questionnaires in English
- Intends for herself and her child to stay in Singapore for the next 5 years
- Access to a smartphone or standard laptop/desktop
- All participants whose data on pregnancy follow-up and delivery would be available from healthcare professionals
- Willing to take part in this study and able to provide written consent
Exclusion Criteria:
- Women with pre-existing or a history of psychotic depression, schizophrenia and bipolar disorders
- Women currently on oral/IV steroids and/or thyroids medication
- Women with a history of thyroid disease
- Women who are pregnant via any assisted reproduction
- Women carrying multiples
- Women currently enrolled into any interventional randomized controlled trials
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pregnant mothers, infants and children
Mothers who are aged 21 - 40 years, below 24 weeks of pregnancy by ultrasonography, are willing to respond to questionnaires in English, and intend to stay in Singapore with her child for the next 5 years are eligible for the study.
Babies born from these mothers will be followed up until the child is at least 4 years old.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cumulative psychosocial risk index of maternal depression and anxiety
Time Frame: From pregnancy up to 2 years postnatal
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To create a cumulative risk index by collecting data using existing validated measures on known risk factors for maternal depression and anxiety, including 1) low socio-economic status, 2) poor marital relations, 3) low social support, 4) high levels of perceived stress, 5) high levels of neuroticism, 6) low self-esteem, 7) poor family function, and 8) childhood adversity in the form of maltreatment and/or poor parental relations.
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From pregnancy up to 2 years postnatal
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Polygenic risk score for differential susceptibility to environmental susceptibility
Time Frame: From pregnancy up to 2 years postnatal
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To identify genotypic variation associated with perinatal maternal mental health
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From pregnancy up to 2 years postnatal
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Determinants of maternal symptoms of depression and anxiety with those that predict positive maternal mental health
Time Frame: From pregnancy up to 2 years postnatal
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To compare the determinants of maternal symptoms of depression and anxiety with those that predict the level of positive mental health
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From pregnancy up to 2 years postnatal
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Influence of perinatal maternal mental health in relation to child development outcomes
Time Frame: From pregnancy to postnatal 6 years
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To examine the impact of perinatal maternal mental health on child development outcomes using standardized clinical measures that have predictive validity for cognitive, emotional and social outcomes in young children.
Our analyses will feature candidate moderators of the association between maternal mental health and child outcomes, including socioeconomic status, family cohesion and parental attitudes.
We will also examine the moderating influence of the polygenic risk scores in determining the strength of the association between maternal mental health and specific child cognitive - emotional outcomes.
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From pregnancy to postnatal 6 years
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Determine specific contribution of maternal prenatal mood factor components to specific developmental outcomes in children
Time Frame: From pregnancy to postnatal 6 years
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Analyses of maternal prenatal mood factors (e.g., maternal positive mental health, somatic complaints, anxiety, etc.) to determine which components contribute to specific developmental outcomes in children.
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From pregnancy to postnatal 6 years
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Influence of genetic susceptibility on maternal mental health and child outcomes
Time Frame: From pregnancy to postnatal 6 years
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Exploratory analysis of the hypothesized moderating effect of the polygenic risk scores to examine those SNP's that best account for the association between the psychosocial risk index, maternal mental health and child outcomes.
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From pregnancy to postnatal 6 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/00967
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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