NCT01011088

Brief Summary

A large number of studies have investigated the psychological disorders occurred in postpartum women, and found that postpartum psychosis is common in new mothers. However, the situation of paternal psychological status after they had their first baby is not assessed. The investigators hypothesized that they had a high occurrence of paternal psychosis after first baby born. In addition, different factors might influence its onset and development in new fathers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 4, 2010

Status Verified

June 1, 2010

Enrollment Period

6 months

First QC Date

November 9, 2009

Last Update Submit

June 3, 2010

Conditions

Psychosis

Keywords

PaternityPsychologyRisk factor

Outcome Measures

Primary Outcomes (1)

  • Incidence of psychoses

    Within the first 90 days and 90 days to 12 months postpartum

Secondary Outcomes (5)

  • Economic level before baby born

    One year before baby born

  • Social status before baby born

    One year before baby born

  • Psychological level before baby born

    From birth of the fathers to the time of their baby born,this is varing from different fathers and received by history records

  • Maternal intrapartum complications

    From the onset of painful labor (0 min of delivery) to the completion of birth (varying in different women and/or different labor procedures)

  • Baby characteristics

    One minute, 5min, 15min after baby was born

Study Arms (2)

Early phase

Psychoses within the first 3 months after baby born

Delayed phase

Psychoses \> 3 months to one year after baby born

Eligibility Criteria

Age19 Years - 49 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Fathers with their first baby born

You may qualify if:

  • Men will be the would-be fathers
  • Chinese

You may not qualify if:

  • Age \< 18 years or \> 50years
  • Not willing to participating or completing the whole study at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 4, 2010

Record last verified: 2010-06

Locations

CN(1)