RIFPP: Risk Factors for Postpartum Psychosis

Sponsor

Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00872313

Collaborator

(none)

4,000

Enrollment

Location

Duration (Months)

95.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Postpartum Period Psychosis

Study Design

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 :

Feb 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1 Psychoses within the first 3 months postpartum
2 Psychoses > 3 months to 6 months postpartum

Outcome Measures

Primary Outcome Measures

Incidence of psychoses [3 months and 6 months postpartum]

Secondary Outcome Measures

Antepartum economic level [One year before labor and delivery (recorded by antepartum communication)]
Antepartum social status [One year before labor and delivery (recorded by antepartum communication)]
Antepartum psychological level [1 day before birth]
Intrapartum complications [1 day after birth]
Baby characteristics [One minute, 5min, 15min after baby was born]
Maternal characteristics [One day after birth]
Medical caregiver characteristics [One day before and after the labor completion]
Parturient family characteristics [One week before labor and delivery, recorded by investigators through patients' antepartum communication]
Intrapartum medical procedures [One day after birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pregnant women
Chinese

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fu Zhou Wang, Dr, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT00872313

Other Study ID Numbers:

NMU-200903-MZ003
NJFY09102M107

First Posted:

Mar 31, 2009

Last Update Posted:

Jan 14, 2014

Last Verified:

Jan 1, 2014

Keywords provided by Fu Zhou Wang, Dr, Nanjing Medical University

Labor

Psychology

Postpartum Psychology

Additional relevant MeSH terms:

Psychotic Disorders

Mental Disorders

Study Results

No Results Posted as of Jan 14, 2014