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Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder

Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder: Patterns, Determinants, and Impact on Perinatal Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02970721
Enrollment
3357
Registered
2016-11-22
Start date
2016-09-30
Completion date
2018-05-31
Last updated
2018-05-11

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

Conditions

Bipolar Disorder, Pregnancy Complications

Keywords

bipolar disorder, adverse outcomes, readmission, polytherapy

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.

Interventions

Antipsychotic monotherapy

Antidepressant monotherapy

DRUGAntipsychotic and Antidepressant

Polytherapy

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal Outcomes (pregnancy)2002-2014Venous Thromboembolism, gestational diabetes, gestational hypertension, preeclampsia or eclampsia, placental abruption, placental infarction
Neonatal Outcomes2002-2014Preterm birth, small for gestational age, large for gestational age, sepsis, mortality, infection, neonatal adaption syndrome, respiratory distress syndrome, seizure, intraventricular haemorrhage
Fetal Outcomes2002-2014Stillbirth, congenital malformation
Labour and Delivery Outcomes2002-2014Caesarean, forceps/ventouse, induced labour, episiotomy or delivery with tear (3rd or 4th degree)
Psychiatric Readmission2002-2014Readmission for mental health reasons ≤ 7 days post-delivery, readmission for mental health reasons within 1 to 12 weeks post-delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026