Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder

Sponsor

Western University, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT02970721

Collaborator

(none)

3,357

Enrollment

19.9

Duration (Months)

Study Details

Study Description

Brief Summary

The objectives of the proposed project are:

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.
To identify the factors associated with use of antipsychotics, antidepressants, and antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar disorder.
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.
To assess the impact of antipsychotics, antidepressants, antipsychotic-antidepressant polytherapy on psychiatric readmission rates during the early postpartum period in women with bipolar disorder.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Pregnancy Complications	Drug: Antipsychotic Drug: Antidepressant Drug: Antipsychotic and Antidepressant

Study Design

Study Type:

Observational

Actual Enrollment :

3357 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Bipolar disorder-treated Individuals in this group are taking any medication (mood stabilizer, antipsychotic, antidepressants, antianxiety) during pregnancy	Drug: Antipsychotic Antipsychotic monotherapy Drug: Antidepressant Antidepressant monotherapy Drug: Antipsychotic and Antidepressant Polytherapy
Bipolar Disorder-Not Treated Individuals in this group are not taking any medications during pregnancy

Arm

Intervention/Treatment

Bipolar disorder-treated

Individuals in this group are taking any medication (mood stabilizer, antipsychotic, antidepressants, antianxiety) during pregnancy

Drug: Antipsychotic

Antipsychotic monotherapy

Drug: Antidepressant

Antidepressant monotherapy

Drug: Antipsychotic and Antidepressant

Polytherapy

Bipolar Disorder-Not Treated

Individuals in this group are not taking any medications during pregnancy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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