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Paternal Psychosis After Baby Born (PAPABAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01011088
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : June 4, 2010
Sponsor:
Information provided by:
Nanjing Medical University

Study Description
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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.


Condition or disease
Psychosis

Study Design
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Study Type : Observational
Actual Enrollment : 387 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Paternal Psychosis Evaluation After First Baby Born
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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Groups and Cohorts
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Group/Cohort
Early phase
Psychoses within the first 3 months after baby born
Delayed phase
Psychoses > 3 months to one year after baby born


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of psychoses [ Time Frame: Within the first 90 days and 90 days to 12 months postpartum ]

Secondary Outcome Measures :
  1. Economic level before baby born [ Time Frame: One year before baby born ]
  2. Social status before baby born [ Time Frame: One year before baby born ]
  3. 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 ]
  4. 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) ]
  5. Baby characteristics [ Time Frame: One minute, 5min, 15min after baby was born ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011088


Locations
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China, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Director: XiaoFeng Shen, MD Nanjing Medical University
More Information
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Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01011088    
Other Study ID Numbers: NMU-200911-MZ018
NJFY09331M012 ( Other Grant/Funding Number: Nanjing Medical University )
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: June 2010
Keywords provided by Nanjing Medical University:
Paternity
Psychology
Risk factor
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders