Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970721
• Other study ID #: 108217
• Status: Completed
• Start date: September 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3357
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Pregnancy Complications

Intervention

Drug:
• Antipsychotic
Antipsychotic monotherapy
• Antidepressant
Antidepressant monotherapy
• Antipsychotic and Antidepressant
Polytherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

References & Publications (3)

Bodén 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Outcomes (pregnancy)	Venous Thromboembolism, gestational diabetes, gestational hypertension, preeclampsia or eclampsia, placental abruption, placental infarction	2002-2014
Primary	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
Primary	Fetal Outcomes	Stillbirth, congenital malformation	2002-2014
Primary	Labour and Delivery Outcomes	Caesarean, forceps/ventouse, induced labour, episiotomy or delivery with tear (3rd or 4th degree)	2002-2014
Primary	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