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Risk Factors for Postpartum Psychosis (RIFPP)

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. Identifier: NCT00872313
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Fu Zhou Wang, Nanjing Medical University

Brief 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 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 or disease
Postpartum Period Psychosis

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Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Potential Risk Factors for Postpartum Psychosis
Study Start Date : February 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Psychoses within the first 3 months postpartum
Psychoses > 3 months to 6 months postpartum

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

Secondary Outcome Measures :
  1. Antepartum economic level [ Time Frame: One year before labor and delivery (recorded by antepartum communication) ]
  2. Antepartum social status [ Time Frame: One year before labor and delivery (recorded by antepartum communication) ]
  3. Antepartum psychological level [ Time Frame: 1 day before birth ]
  4. Intrapartum complications [ Time Frame: 1 day after birth ]
  5. Baby characteristics [ Time Frame: One minute, 5min, 15min after baby was born ]
  6. Maternal characteristics [ Time Frame: One day after birth ]
  7. Medical caregiver characteristics [ Time Frame: One day before and after the labor completion ]
  8. Parturient family characteristics [ Time Frame: One week before labor and delivery, recorded by investigators through patients' antepartum communication ]
  9. Intrapartum medical procedures [ Time Frame: One day after birth ]

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

Inclusion Criteria:

  • Pregnant women
  • Chinese

Exclusion Criteria:

  • Age < 18 years or > 50 years
  • Gestational age < 32 weeks

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 identifier (NCT number): NCT00872313

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China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
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Study Director: XiaoFeng Shen, MD Nanjing Medical University
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Responsible Party: Fu Zhou Wang, Dr, Nanjing Medical University Identifier: NCT00872313    
Other Study ID Numbers: NMU-200903-MZ003
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Fu Zhou Wang, Nanjing Medical University:
Postpartum Psychology
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders