Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00580268

Enrollment

118

Registered

2007-12-24

Start date

2005-08-31

Completion date

2013-07-31

Last updated

2014-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Neonatal Outcome, Psychiatric Morbidity

Brief summary

The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period; 2. euthymic at the time of conception; 3. able to give informed consent and comply with study procedures; 4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

Exclusion criteria

1. active suicidality or homicidality; 2. active substance use disorder with 6 months prior to enrollment, or 3. positive urine drug screen at enrollment.

Design outcomes

Primary

Measure	Time frame
psychiatric morbidity	15 months

Secondary

Measure	Time frame
obstetrical outcomes	6 months

Countries

United States

Outcome results