PsychosisPAPABABNCT01011088
Paternal Psychosis After Baby Born
An observational study of Psychosis, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, men only
- Conditions the study is for
- Psychosis
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Men only
- No healthy volunteers
- Adult
Study population: Fathers with their first baby born
Who may be able to join
- Men will be the would-be fathers
- Chinese
Who cannot join
- Age < 18 years or > 50years
- Not willing to participating or completing the whole study at any time
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Paternal Psychosis Evaluation After First Baby Born
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.
- Conditions
- Psychosis
- Keywords
- Paternity, Psychology, Risk factor
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Not any artificial interventions were given
| Study group | Role | What they receive |
|---|---|---|
| Early phase | Psychoses within the first 3 months after baby born | |
| Delayed phase | Psychoses > 3 months to one year after baby born |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of psychoses
Measured: Within the first 90 days and 90 days to 12 months postpartum
Secondary outcomes (5)
Economic level before baby born
Measured: One year before baby born
Social status before baby born
Measured: One year before baby born
Psychological level before baby born
Measured: 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
Measured: 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
Measured: One minute, 5min, 15min after baby was born
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011088
- Sponsor's protocol ID
- NMU-200911-MZ018
- Other IDs
- NJFY09331M012
- Acronym
- PAPABAB
- Status last verified
- Jun 2010
- First submitted
- 9 Nov 2009
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paternal Psychosis Evaluation After First Baby Born
- ClinicalTrials.gov ID
- NCT01011088
- Acronym / sponsor ID
- PAPABAB / NMU-200911-MZ018
- Conditions
- Psychosis
- Keywords
- Paternity, Psychology, Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early phase | – | –Psychoses within the first 3 months after baby born |
| Delayed phase | – | –Psychoses > 3 months to one year after baby born |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fathers with their first baby born
Key inclusion criteria (2 listed)
- Men will be the would-be fathers
- Chinese
Key exclusion criteria (2 listed)
- Age < 18 years or > 50years
- Not willing to participating or completing the whole study at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not any artificial interventions were given | Other | Delayed phase, Early phase |
Primary outcome
Incidence of psychoses
Time frame: Within the first 90 days and 90 days to 12 months postpartum
5 secondary outcomes
Economic level before baby born
Time frame: One year before baby born
Social status before baby born
Time frame: One year before baby born
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
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)
Baby characteristics
Time frame: One minute, 5min, 15min after baby was born
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of psychoses (time frame: Within the first 90 days and 90 days to 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.