Impact of Pregnancy and the Postpartum Period on Women With Bipolar Disorder

Bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy,
and ability to function. In women, it is particularly prevalent during the childbearing
years. It is estimated that 100,000 of the women who give birth each year have bipolar
disorder. Very little is known, however, about the impact of pregnancy and the postpartum
period on the disorder. Evidence-based guidelines are necessary for the management of
bipolar disorder during and after pregnancy. In order to develop such guidelines, more
information is needed about the clinical, psychosocial, and pharmacologic predictors of a
bipolar disorder recurrence during pregnancy. This study will determine the risk factors for
a depressive, manic, or hypomanic episode during pregnancy and the postpartum period in
women with bipolar disorder.

Women interested in participating in this observational study will first attend a study
visit to determine their eligibility for participation. At this visit, a complete medical
and psychiatric history will be taken, as well as blood and urine samples. The visit will
last approximately 2.5 hours. If eligible, participants will attend study visits monthly
during pregnancy and every 6 weeks for 6 months postpartum. At each visit, which will last
45 to 60 minutes, participants will be interviewed by a study physician and a research
assistant. Additionally, participants will fill out questionnaires about Bipolar disorder
symptoms and treatment, life stressors, and any medications or substances that have been
taken since their last visit. Participants who are not yet pregnant at the time of study
entry will attend a study visit once every 3 months until conception. Upon becoming
pregnant, they will follow the same study visit schedule as participants who were pregnant
at the time of study entry. No treatment will be provided in this study. Participants will
continue receiving treatment from their regular physicians throughout the study.

Inclusion Criteria:

- Meets DSM-IV criteria for bipolar disorder of any type (1 or 2)

- Currently pregnant and within 14 weeks gestation (as measured by date of last
menstrual period) or planning to become pregnant

- No mood abnormalities at the time of conception

- Currently being treated by a psychiatrist, physician, or mental health clinician

Exclusion Criteria:

- Actively suicidal or homicidal

- Any serious medical illness