NCT07432217

Brief Summary

This study recruits women from early-mid pregnancy and later follows their children after birth, tracking both the mother and child until the child reaches at least 4 years of age. The study aims to examine the determinants of maternal mental health during pregnancy and how genetic factors could influence maternal mental health and child outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,419

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Sep 2019Jun 2029

Study Start

First participant enrolled

September 30, 2019

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2029

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

9.7 years

First QC Date

February 12, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

NeurodevelopmentGeneticsMental Health

Outcome Measures

Primary Outcomes (3)

  • Cumulative psychosocial risk index of maternal depression and anxiety

    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.

    From pregnancy up to 2 years postnatal

  • Polygenic risk score for differential susceptibility to environmental susceptibility

    To identify genotypic variation associated with perinatal maternal mental health

    From pregnancy up to 2 years postnatal

  • Determinants of maternal symptoms of depression and anxiety with those that predict positive maternal mental health

    To compare the determinants of maternal symptoms of depression and anxiety with those that predict the level of positive mental health

    From pregnancy up to 2 years postnatal

Secondary Outcomes (3)

  • Influence of perinatal maternal mental health in relation to child development outcomes

    From pregnancy to postnatal 6 years

  • Determine specific contribution of maternal prenatal mood factor components to specific developmental outcomes in children

    From pregnancy to postnatal 6 years

  • Influence of genetic susceptibility on maternal mental health and child outcomes

    From pregnancy to postnatal 6 years

Study Arms (1)

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.

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Singapore

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Human Development and Potential

Singapore, 117609, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of human biological materials, such as buccal, saliva and blood

MeSH Terms

Conditions

Neurologic ManifestationsGenetic Predisposition to DiseasePsychological Well-Being

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease SusceptibilityDisease AttributesPathologic ProcessesPersonal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 25, 2026

Study Start

September 30, 2019

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 16, 2029

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations