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The objectives of the proposed project are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bipolar disorder-treated | Individuals in this group are taking any medication (mood stabilizer, antipsychotic, antidepressants, antianxiety) during pregnancy |
| |
| Bipolar Disorder-Not Treated | Individuals in this group are not taking any medications during pregnancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antipsychotic | Drug | Antipsychotic monotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Outcomes (pregnancy) | Venous Thromboembolism, gestational diabetes, gestational hypertension, preeclampsia or eclampsia, placental abruption, placental infarction | 2002-2014 |
| Neonatal Outcomes | Preterm birth, small for gestational age, large for gestational age, sepsis, mortality, infection, neonatal adaption syndrome, respiratory distress syndrome, seizure, intraventricular haemorrhage | 2002-2014 |
| Fetal Outcomes | Stillbirth, congenital malformation | 2002-2014 |
| Labour and Delivery Outcomes | Caesarean, forceps/ventouse, induced labour, episiotomy or delivery with tear (3rd or 4th degree) | 2002-2014 |
| Psychiatric Readmission | Readmission for mental health reasons ≤ 7 days post-delivery, readmission for mental health reasons within 1 to 12 weeks post-delivery | 2002-2014 |
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Inclusion Criteria:
Women were included in our study cohort if they met at least one of the following criteria: (i) an inpatient hospitalization with a primary discharge diagnosis of BD prior to the index pregnancy; (ii) an outpatient OHIP fee code for a mood disorder plus a prescription of a mood stabilizer prior to the index pregnancy (note that the outpatient OHIP fee code (296) without a prescription would not have been sufficient to identify BD patients because the fee code is used concurrently used for diagnosis of unipolar depression). Additionally, women were included in the study cohort if they were continuously covered for ODB throughout their pregnancy, defined as having filled any provincially funded drug prescription within six months prior to conception and another either during their pregnancy or within six months after delivery.
Exclusion Criteria:
(1) women with gestational weeks less than 20 and more than 45 at delivery; (2) pregnancies with multiple overlapping records over the study time period; (3) any data with inconsistencies and duplicate records for pregnancy; (4) any woman sharing the newborn's IKN, given that we would be unable to differentiate between the two persons; (5) observations with missing birth date for the baby and the time period between the mother's admission and discharge date greater than 14 days (since we were unable to determine the conception date for these women; and (6) women who filled a treatment prescription up to 30 days prior to pregnancy and none during the period of pregnancy.very
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Women between the ages of 13 and 50 years who were hospitalized for a singleton obstetrical delivery between 2002-2014. Additionally, these women must be covered under the provincial drug benefit plan during index pregnancy, which is defined as having filled a drug prescription in the period from six months prior to pregnancy to six months after delivery. For women who had multiple pregnancies over the study period, we will select their first pregnancy as the index pregnancy.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23137820 | Background | Boden R, Lundgren M, Brandt L, Reutfors J, Andersen M, Kieler H. Risks of adverse pregnancy and birth outcomes in women treated or not treated with mood stabilisers for bipolar disorder: population based cohort study. BMJ. 2012 Nov 8;345:e7085. doi: 10.1136/bmj.e7085. | |
| 25972273 | Background | Vigod SN, Gomes T, Wilton AS, Taylor VH, Ray JG. Antipsychotic drug use in pregnancy: high dimensional, propensity matched, population based cohort study. BMJ. 2015 May 13;350:h2298. doi: 10.1136/bmj.h2298. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D014150 | Antipsychotic Agents |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Antidepressant |
| Drug |
Antidepressant monotherapy |
|
| Antipsychotic and Antidepressant | Drug | Polytherapy |
|
| 28040641 | Background | Broeks SC, Thisted Horsdal H, Glejsted Ingstrup K, Gasse C. Psychopharmacological drug utilization patterns in pregnant women with bipolar disorder - A nationwide register-based study. J Affect Disord. 2017 Mar 1;210:158-165. doi: 10.1016/j.jad.2016.12.001. Epub 2016 Dec 8. |
| D000091642 | Urogenital Diseases |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |