Postpartum PeriodRIFPPNCT00872313
Risk Factors for Postpartum Psychosis
An observational study of Postpartum Period and Psychosis, run by Nanjing Medical University at 1 site in China.
Trial summary
A range of psychological disorders occur in women in the postpartum period. These include "the blues", which occurs in the first days after birth and which is very common and self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in the first weeks after birth; and mild to moderate… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Period, Psychosis
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Aug 2012
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Parturients undergoing spontaneous or induced labor or cesarean delivery
Who may be able to join
- Pregnant women
- Chinese
Who cannot join
- Age < 18 years or > 50 years
- Gestational age < 32 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Potential Risk Factors for Postpartum Psychosis
A range of psychological disorders occur in women in the postpartum period. These include "the blues", which occurs in the first days after birth and which is very common and self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in the first weeks after birth; and mild to moderate depression, occurring weeks to months after birth. Studies have been done focused on postpartum psychosis using a retrospective investigation, which gave only a limited material on the prevalence of psychological disorders in postpartum women. The investigators hypothesized that different pathways to psychosis function as the risk factors which may be overlapped, truly independent, mediating, or moderating, in new mothers who are at high risk and/or during the early period of delivery. In addition, the investigators purposed that the temporal sequence of biological, social and demographic variables are also the potential factors contributing to the development of postpartum psychosis.
- Conditions
- Postpartum Period, Psychosis
- Keywords
- Labor, Psychology, Postpartum Psychology
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Psychoses within the first 3 months postpartum | |
| 2 | Psychoses > 3 months to 6 months postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of psychoses
Measured: 3 months and 6 months postpartum
Secondary outcomes (9)
Antepartum economic level
Measured: One year before labor and delivery (recorded by antepartum communication)
Antepartum social status
Measured: One year before labor and delivery (recorded by antepartum communication)
Antepartum psychological level
Measured: 1 day before birth
Intrapartum complications
Measured: 1 day after birth
Baby characteristics
Measured: One minute, 5min, 15min after baby was born
Maternal characteristics
Measured: One day after birth
Medical caregiver characteristics
Measured: One day before and after the labor completion
Parturient family characteristics
Measured: One week before labor and delivery, recorded by investigators through patients' antepartum communication
Intrapartum medical procedures
Measured: One day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies 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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Zhou Wang, Nanjing Medical University
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872313
- Sponsor's protocol ID
- NMU-200903-MZ003
- Other IDs
- NJFY09102M107
- Acronym
- RIFPP
- Status last verified
- Jan 2014
- First submitted
- 30 Mar 2009
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Risk Factors for Postpartum Psychosis
- ClinicalTrials.gov ID
- NCT00872313
- Acronym / sponsor ID
- RIFPP / NMU-200903-MZ003
- Conditions
- Postpartum Period, Psychosis
- Keywords
- Labor, Psychology, Postpartum Psychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 Mar 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 range of psychological disorders occur in women in the postpartum period. These include "the blues", which occurs in the first days after birth and which is very common and self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in the first weeks after birth; and mild to moderate depression, occurring weeks to months after birth. Studies have been done focused on postpartum psychosis using a retrospective investigation, which gave only a limited material on the prevalence of psychological disorders in postpartum women. The investigators hypothesized that different pathways to psychosis function as the risk factors which may be overlapped, truly independent, mediating, or moderating, in new mothers who are at high risk and/or during the early period of delivery. In addition, the investigators purposed that the temporal sequence of biological, social and demographic variables are also the potential factors contributing to the development of postpartum psychosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Psychoses within the first 3 months postpartum |
| 2 | – | –Psychoses > 3 months to 6 months postpartum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturients undergoing spontaneous or induced labor or cesarean delivery
Key inclusion criteria (2 listed)
- Pregnant women
- Chinese
Key exclusion criteria (2 listed)
- Age < 18 years or > 50 years
- Gestational age < 32 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of psychoses
Time frame: 3 months and 6 months postpartum
9 secondary outcomes
Antepartum economic level
Time frame: One year before labor and delivery (recorded by antepartum communication)
Antepartum social status
Time frame: One year before labor and delivery (recorded by antepartum communication)
Antepartum psychological level
Time frame: 1 day before birth
Intrapartum complications
Time frame: 1 day after birth
Baby characteristics
Time frame: One minute, 5min, 15min after baby was born
Maternal characteristics
Time frame: One day after birth
Medical caregiver characteristics
Time frame: One day before and after the labor completion
Parturient family characteristics
Time frame: One week before labor and delivery, recorded by investigators through patients' antepartum communication
Intrapartum medical procedures
Time frame: One day after birth
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 14 Jan 2014.
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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 Postpartum Period and 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 14 Jan 2014. 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: 3 months and 6 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 14 Jan 2014.