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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02026804
Other study ID # Y21000505
Secondary ID
Status Recruiting
Phase N/A
First received December 30, 2013
Last updated January 20, 2015
Start date January 2013

Study information

Verified date January 2015
Source Zhejiang Provincial Natural Science Foundation of China
Contact Youding Zhang, MD
Phone 86-580-2065188
Email tougaoing@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Aged at least 18 years of age

- 8 to 12 weeks of pregnancy

- There is no history of mental illness

- Had perinatal health care in a Women's & Children's Health Hospital

Exclusion Criteria:

- The obvious body disease

- Having anxiety, phobia, hypochondriasis, obsessive-compulsive disorder or depression before pregnancy

- Having severe complications during pregnancy

- Fetal malformation or abortion

- Can't understand the questionnaire

- Without informed consent

- More than 13 weeks of pregnancy

- Less than 18 years of age

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhoushan Women's & Children's Health Hospital Zhoushan Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Provincial Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of mental disorders during different periods of pregnancy We would like to find the incidence of mental disorders in early (8-12 weeks),middle (18-22 weeks) and later(32 weeks to delivery) period of pregnancy from 8 weeks of pregnancy to delivery No
Secondary pregnancy outcomes We would like to explore which period of mental disorders had the most significant infuences on pregnancy outcomes including obstetrical complications(e.g.gestational diabetes mellitus(GDM),hypertensive disorder complicating pregnancy(HDCP)),outcome of fetus(e.g.preterm,low birth weight and fetal anomaly) and health of infant and puerpera. from 8 weeks of pregnancy to 6 months after delivery No