Risk Factors for Postpartum Psychosis

Psychosis Clinical Trial

— RIFPP  

Official title:

Potential Risk Factors for Postpartum Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872313
• Other study ID #: NMU-200903-MZ003
• Secondary ID: NJFY09102M107
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: January 11, 2014
• Start date: February 2009
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women

• Chinese

Exclusion Criteria:

• Age < 18 years or > 50 years

• Gestational age < 32 weeks

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Postpartum Period
• Psychosis
• Psychotic Disorders

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of psychoses		3 months and 6 months postpartum	Yes
Secondary	Antepartum economic level		One year before labor and delivery (recorded by antepartum communication)	No
Secondary	Antepartum social status		One year before labor and delivery (recorded by antepartum communication)	No
Secondary	Antepartum psychological level		1 day before birth	No
Secondary	Intrapartum complications		1 day after birth	Yes
Secondary	Baby characteristics		One minute, 5min, 15min after baby was born	No
Secondary	Maternal characteristics		One day after birth	Yes
Secondary	Medical caregiver characteristics		One day before and after the labor completion	No
Secondary	Parturient family characteristics		One week before labor and delivery, recorded by investigators through patients' antepartum communication	No
Secondary	Intrapartum medical procedures		One day after birth	Yes