Paternal Psychosis After Baby Born (PAPABAB)
This study has been completed.
Sponsor:
Nanjing Medical University
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01011088
First received: November 9, 2009
Last updated: June 3, 2010
Last verified: June 2010
| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2009 | ||||
| Last Updated Date | June 3, 2010 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of psychoses [ Time Frame: Within the first 90 days and 90 days to 12 months postpartum ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01011088 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Paternal Psychosis After Baby Born | ||||
| Official Title ICMJE | Paternal Psychosis Evaluation After First Baby Born | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Fathers with their first baby born |
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| Condition ICMJE | Psychosis | ||||
| Intervention ICMJE | Other: Not available
Not any artificial interventions were given |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 387 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 19 Years to 49 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01011088 | ||||
| Other Study ID Numbers ICMJE | NMU-200911-MZ018, NJFY09331M012 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | XiaoFeng Shen, Nanjing Medical University | ||||
| Study Sponsor ICMJE | Nanjing Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nanjing Medical University | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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