Investigating how pregnancy health affects children's development and behavior

A Prospective Cohort Study of the Association Between Pregnancy Health and Offspring Developmental & Behavioral Outcomes(Multi-Centered)

This study is trying to see how different factors during pregnancy, like a mother's health and environment, can affect how children develop and behave as they grow up.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 3 Months to 72 Months
• Sex: All
• Sponsor: Children's Hospital of Chongqing Medical University (Academic / other)
• Locations: 5 sites (Chongqing, Chongqing Municipality and 4 other locations)
• Trial ID: NCT04017286 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between various genetic and environmental factors during pregnancy and their impact on the cognitive development of offspring. Pregnant women aged 20-49 will be enrolled, and data will be collected through questionnaires, blood samples, and developmental screenings at various stages of their child's growth. The study will assess factors such as maternal nutrition, mental health, and exposure to environmental toxins, and how these may correlate with developmental disorders in children. The goal is to identify potential risk factors for conditions like ADHD and developmental delays.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 20-49 who can complete the necessary assessments and have normal to mild-moderate depression scores.

Not a fit: Patients with severe depression, cognitive dysfunction, or other mental disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how maternal health during pregnancy influences child development, potentially leading to improved prenatal care practices.

How similar studies have performed: While similar studies have explored the impact of maternal health on child development, this study's specific focus on genetic and environmental interactions is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Inclusion criteria for pregnant women: Aged 20\~49;
2. no cognitive impairment, able to complete the scale test;
3. Hamilton Depression Scale (HAMD questionnaire) is normal (HAMD score \<8 points) or mild to moderate positive (HAMD questionnaire score: 8\~35 points);
4. Participants are asked for their own written informed content for the study;

Exclusion Criteria:

1. Patients receiving anti-depression therapy during the first 6 months of gestation or during pregnancy;
2. Patients with severe depression with scores of no less than 35 points in the HAMD questionnaire;
3. Patients with other mental disorders;
4. Patients with neurological diseases;
5. Patients with cognitive dysfunction.

Where this trial is running

Chongqing, Chongqing Municipality and 4 other locations

• The People's Hospital of Yubei District of Chongqing City — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Chongqing First People's Hospital of Liangjiang New Area — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The Central Hospital of Jiangjin District of Chongqing City — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Wanzhou Health Center for Women and Children — Chongqing, Chongqing Municipality, China (Recruiting)
• The Maternal and Child Health Hospital of Hainan Province — Haikou, Hainan, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Tanya Froehlich, MD,MS — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Li Chen, MD

Conditions Children Behavior Problem; Pregnancy; Developmental assessment; Homocysteine; physique growth; nutrients