- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872313
Risk Factors for Postpartum Psychosis (RIFPP)
January 11, 2014 updated by: Fu Zhou Wang, Nanjing Medical University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Health Care Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Parturients undergoing spontaneous or induced labor or cesarean delivery
Description
Inclusion Criteria:
- Pregnant women
- Chinese
Exclusion Criteria:
- Age < 18 years or > 50 years
- Gestational age < 32 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Psychoses within the first 3 months postpartum
|
|
2
Psychoses > 3 months to 6 months postpartum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of psychoses
Time Frame: 3 months and 6 months postpartum
|
3 months and 6 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Antepartum economic level
Time Frame: One year before labor and delivery (recorded by antepartum communication)
|
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)
|
One year before labor and delivery (recorded by antepartum communication)
|
|
Antepartum psychological level
Time Frame: 1 day before birth
|
1 day before birth
|
|
Intrapartum complications
Time Frame: 1 day after birth
|
1 day after birth
|
|
Baby characteristics
Time Frame: One minute, 5min, 15min after baby was born
|
One minute, 5min, 15min after baby was born
|
|
Maternal characteristics
Time Frame: One day after birth
|
One day after birth
|
|
Medical caregiver characteristics
Time Frame: One day before and after the labor completion
|
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
|
One week before labor and delivery, recorded by investigators through patients' antepartum communication
|
|
Intrapartum medical procedures
Time Frame: One day after birth
|
One day after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
March 30, 2009
First Submitted That Met QC Criteria
March 30, 2009
First Posted (Estimate)
March 31, 2009
Study Record Updates
Last Update Posted (Estimate)
January 14, 2014
Last Update Submitted That Met QC Criteria
January 11, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMU-200903-MZ003
- NJFY09102M107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.