- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026804
Prevalence , Associated Factors and Influences of Prenatal Mental Disorders
January 20, 2015 updated by: Zhejiang Provincial Natural Science Foundation of China
The purpose of this study is to find the incidence of mental disorders during different periods of pregnancy and its associated factors and consequences.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Zhoushan, Zhejiang, China, 316000
- Recruiting
- Zhoushan Women's & Children's Health Hospital
-
Contact:
- Zhang
- Phone Number: 86-580-2065188
-
Principal Investigator:
- Youding Zhang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant women who had perinatal health care in a Women's & Children's Health Hospital of zhejiang province, China
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Prenatal mental disorders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of mental disorders during different periods of pregnancy
Time Frame: from 8 weeks of pregnancy to delivery
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pregnancy outcomes
Time Frame: from 8 weeks of pregnancy to 6 months after delivery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
December 30, 2013
First Submitted That Met QC Criteria
January 1, 2014
First Posted (Estimate)
January 3, 2014
Study Record Updates
Last Update Posted (Estimate)
January 22, 2015
Last Update Submitted That Met QC Criteria
January 20, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Y21000505
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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