Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder

NCT02970721 | Completed

• 1 other identifier: 108217
• Study Type: observational
• Target: 3,357
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of the proposed project are:

1. 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. 2.To identify the factors associated with use of antipsychotics, antidepressants, and antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar disorder.
3. 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. 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.

Conditions

Bipolar Disorder; Pregnancy Complications

Keywords

bipolar disorder; adverse outcomes; readmission; polytherapy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Bipolar disorder-treated

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

Drug: Antipsychotic; Drug: Antidepressant; Drug: Antipsychotic and Antidepressant

Bipolar Disorder-Not Treated

Individuals in this group are not taking any medications during pregnancy

Interventions

Antipsychotic DRUG

Antipsychotic monotherapy

Bipolar disorder-treated

Antidepressant DRUG

Antidepressant monotherapy

Bipolar disorder-treated

Antipsychotic and Antidepressant DRUG

Polytherapy

Bipolar disorder-treated

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Western University, Canada: lead

Related Publications (3)

• 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.

  PMID: 23137820 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.

  PMID: 25972273 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.

  PMID: 28040641 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Pregnancy Complications

Interventions

Antipsychotic Agents; Antidepressive Agents

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05