Risk Factors for Postpartum Psychosis (RIFPP)

This study has been completed.
Information provided by (Responsible Party):
Fu Zhou Wang, Nanjing Medical University
ClinicalTrials.gov Identifier:
First received: March 30, 2009
Last updated: January 11, 2014
Last verified: January 2014
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.

Postpartum Period

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 Nanjing Medical University:

Primary Outcome Measures:
  • Incidence of psychoses [ Time Frame: 3 months and 6 months postpartum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antepartum economic level [ Time Frame: One year before labor and delivery (recorded by antepartum communication) ] [ Designated as safety issue: No ]
  • Antepartum social status [ Time Frame: One year before labor and delivery (recorded by antepartum communication) ] [ Designated as safety issue: No ]
  • Antepartum psychological level [ Time Frame: 1 day before birth ] [ Designated as safety issue: No ]
  • Intrapartum complications [ Time Frame: 1 day after birth ] [ Designated as safety issue: Yes ]
  • Baby characteristics [ Time Frame: One minute, 5min, 15min after baby was born ] [ Designated as safety issue: No ]
  • Maternal characteristics [ Time Frame: One day after birth ] [ Designated as safety issue: Yes ]
  • Medical caregiver characteristics [ Time Frame: One day before and after the labor completion ] [ Designated as safety issue: No ]
  • Parturient family characteristics [ Time Frame: One week before labor and delivery, recorded by investigators through patients' antepartum communication ] [ Designated as safety issue: No ]
  • Intrapartum medical procedures [ Time Frame: One day after birth ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00872313

China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
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 
Study First Received: March 30, 2009
Last Updated: January 11, 2014
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Postpartum Psychology

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

ClinicalTrials.gov processed this record on May 24, 2016