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Paternal Psychosis After Baby Born (PAPABAB)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01011088
First received: November 9, 2009
Last updated: June 3, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Psychosis
 Other: Not available

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Paternal Psychosis Evaluation After First Baby Born

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Incidence of psychoses [ Time Frame: Within the first 90 days and 90 days to 12 months postpartum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Economic level before baby born [ Time Frame: One year before baby born ] [ Designated as safety issue: No ]
  • Social status before baby born [ Time Frame: One year before baby born ] [ Designated as safety issue: No ]
  • Psychological level before baby born [ Time Frame: From birth of the fathers to the time of their baby born,this is varing from different fathers and received by history records ] [ Designated as safety issue: No ]
  • Maternal intrapartum complications [ Time Frame: From the onset of painful labor (0 min of delivery) to the completion of birth (varying in different women and/or different labor procedures) ] [ Designated as safety issue: Yes ]
  • Baby characteristics [ Time Frame: One minute, 5min, 15min after baby was born ] [ Designated as safety issue: No ]

Enrollment: 387
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early phase
Psychoses within the first 3 months after baby born
 Other: Not available
Not any artificial interventions were given
Delayed phase
Psychoses > 3 months to one year after baby born
 Other: Not available
Not any artificial interventions were given

  Eligibility

Ages Eligible for Study:   19 Years to 49 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Fathers with their first baby born

Criteria

Inclusion Criteria:

  • Men will be the would-be fathers
  • Chinese

Exclusion Criteria:

  • Age < 18 years or > 50years
  • Not willing to participating or completing the whole study at any time
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011088

Locations
China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01011088     History of Changes
Other Study ID Numbers: NMU-200911-MZ018, NJFY09331M012
Study First Received: November 9, 2009
Last Updated: June 3, 2010
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Paternity
Psychology
Risk factor

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 17, 2013