Risk Factors for Postpartum Psychosis (RIFPP)

January 11, 2014 updated by: Fu Zhou Wang, Nanjing Medical University

Potential Risk Factors for Postpartum Psychosis

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Parturients undergoing spontaneous or induced labor or cesarean delivery

Description

Inclusion Criteria:

  • Pregnant women
  • Chinese

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Psychoses within the first 3 months postpartum
2
Psychoses > 3 months to 6 months postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of psychoses
Time Frame: 3 months and 6 months postpartum
3 months and 6 months postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 11, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NMU-200903-MZ003
  • NJFY09102M107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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