Clinical trial NCT02970721: Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Official title: Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder: Patterns, Determinants, and Impact on Perinatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Pregnancy Complications
Keywords: bipolar disorder
adverse outcomes
readmission
polytherapy
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 3357
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The objectives of the proposed project are:

1. To describe the patterns of mood stabilizer, antipsychotic, antidepressant, and anxiolytic prescriptions during pregnancy over a period of 12 years (2002-2014) in women aged 13 to 50 years who are diagnosed with bipolar disorder in Ontario.
2. To identify the factors associated with use of antipsychotics, antidepressants, and antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar disorder.
3. To assess the impact of antipsychotics, antidepressants, and antipsychotic-antidepressant polytherapy on the risk of maternal, neonatal, and labour and delivery outcomes in women with bipolar disorder.
4. To assess the impact of antipsychotics, antidepressants, antipsychotic-antidepressant polytherapy on psychiatric readmission rates during the early postpartum period in women with bipolar disorder.


Eligibility criteria: 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

Primary outcomes:
measure: Maternal Outcomes (pregnancy)
timeFrame: 2002-2014
measure: Neonatal Outcomes
timeFrame: 2002-2014
measure: Fetal Outcomes
timeFrame: 2002-2014
measure: Labour and Delivery Outcomes
timeFrame: 2002-2014
measure: Psychiatric Readmission
timeFrame: 2002-2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.