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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH075921 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Pregnant women with bipolar disorder | ||
| 2 | Pregnant women without bipolar disorder |
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| Measure | Description | Time Frame |
|---|---|---|
| SIGH-ADS | 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum | |
| Mania Rating Scale | 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum | |
| Bayley Scales of Infant Development | 12, 28, 52 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain in pregnancy | 20,30,36 weeks gestation | |
| Structured Clinical Interview for DSM-IV | 20 weeks gestation at enrollment | |
| Nutritional Blood Levels |
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Inclusion Criteria for Bipolar Subjects:
Inclusion Criteria for non-Bipolar Control Subject:
Exclusion Criteria for all:
Additional Exclusion Criteria for Control Subjects:
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Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any subtype
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| Name | Affiliation | Role |
|---|---|---|
| Katherine L Wisner, MD MS | Department of Psychiatry, School of Medicine, University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30248632 | Derived | Wisner KL, Sit D, O'Shea K, Bogen DL, Clark CT, Pinheiro E, Yang A, Ciolino JD. Bipolar disorder and psychotropic medication: Impact on pregnancy and neonatal outcomes. J Affect Disord. 2019 Jan 15;243:220-225. doi: 10.1016/j.jad.2018.09.045. Epub 2018 Sep 18. | |
| 28570796 | Derived | Yang A, Ciolino JD, Pinheiro E, Rasmussen-Torvik LJ, Sit DKY, Wisner KL. Neonatal Discontinuation Syndrome in Serotonergic Antidepressant-Exposed Neonates. J Clin Psychiatry. 2017 May;78(5):605-611. doi: 10.4088/JCP.16m11044. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum |
| Maternal Functioning and Gratification | 2, 12, 28, 52 weeks postpartum |
| Infant physical exam | 2,12,28,52 weeks post delivery |
| 28068465 | Derived | Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Sit DK, Wisner KL. One-Year Developmental Outcomes for Infants of Mothers With Bipolar Disorder. J Clin Psychiatry. 2017 Sep-Oct;78(8):1083-1090. doi: 10.4088/JCP.15m10535. |
| 26692255 | Derived | Kim DR, Pinheiro E, Luther JF, Eng HF, Dills JL, Wisniewski SR, Wisner KL. Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res. 2016 Feb;73:79-85. doi: 10.1016/j.jpsychires.2015.11.005. Epub 2015 Nov 19. |