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Risk Factors for Postpartum Psychosis (RIFPP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872313
First Posted: March 31, 2009
Last Update Posted: January 14, 2014
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.
Information provided by (Responsible Party):
Fu Zhou Wang, Nanjing Medical University
  Purpose
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.

Condition
Postpartum Period Psychosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Potential Risk Factors for Postpartum Psychosis

Resource links provided by NLM:


Further study details as provided by Fu Zhou Wang, Nanjing Medical University:

Primary Outcome Measures:
  • Incidence of psychoses [ Time Frame: 3 months and 6 months postpartum ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4000
Study Start Date: February 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Psychoses within the first 3 months postpartum
2
Psychoses > 3 months to 6 months postpartum

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parturients undergoing spontaneous or induced labor or cesarean delivery
Criteria

Inclusion Criteria:

  • Pregnant women
  • Chinese

Exclusion Criteria:

  • Age < 18 years or > 50 years
  • Gestational age < 32 weeks
  Contacts and Locations
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): NCT00872313


Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Responsible Party: Fu Zhou Wang, Dr, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00872313     History of Changes
Other Study ID Numbers: NMU-200903-MZ003
NJFY09102M107
First Submitted: March 30, 2009
First Posted: March 31, 2009
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Fu Zhou Wang, Nanjing Medical University:
Labor
Psychology
Postpartum Psychology

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders