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Risk Factors for Postpartum Psychosis (RIFPP)

This study is currently recruiting participants.
Verified July 2011 by Nanjing Medical University
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00872313
First received: March 30, 2009
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 4000
Study Start Date: February 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (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

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

Criteria

Inclusion Criteria:

  • Pregnant women
  • Chinese

Exclusion Criteria:

  • Age < 18 years or > 50 years
  • Gestational age < 32 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872313

Contacts
Contact: FuZhou Wang, MD 86-25-84460777 ext 3301 zfwang50@gmail.com
Contact: ShiQin Xu, MD 86-25-84460777 ext 3301 xusqnj@sina.com

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD     86-25-84460777 ext 1508     pyz1131@hotmail.com    
Contact: XiRong Guo, MD     86-25-84460777 ext 1508     xrguonjmueducn@yahoo.com.cn    
Sub-Investigator: YuSheng Liu, MD            
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, 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: July 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Labor
Psychology
Postpartum Psychology

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013