NCT02026804

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

December 30, 2013

Last Update Submit

January 20, 2015

Conditions

Mental Disorder During Pregnancy - Baby Not Yet Delivered

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • pregnancy outcomes

    from 8 weeks of pregnancy to 6 months after delivery

Study Arms (1)

Prenatal mental disorders

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women who had perinatal health care in a Women's \& Children's Health Hospital of zhejiang province, China

You may qualify if:

  • Aged at least 18 years of age
  • to 12 weeks of pregnancy
  • There is no history of mental illness
  • Had perinatal health care in a Women's \& Children's Health Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhoushan Women's & Children's Health Hospital

Zhoushan, Zhejiang, 316000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, white cells, placenta tissue

Central Study Contacts

Youding Zhang, MD

CONTACT

86-580-2065188tougaoing@163.com

Study Design

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

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 3, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

CN(1)