Domperidone and Risk of Serious Cardiac Events in Postpartum Women

NCT04024865 | Completed

• 1 other identifier: Q16-10
• Study Type: observational
• Target: 184,929
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the use of domperidone is associated with an increased risk of serious cardiac events among postpartum women in the six months following delivery. The hypothesis is that the use of domperidone will be associated with an increased risk of serious cardiac events among postpartum women. The investigators will carry out separate population-based cohort studies using health care databases in five Canadian provinces. Women with live births will be eligible to enter the cohort. We will identify all women who start domperidone during the six months following delivery and match them to similar women who do not start domperidone, with all included women followed until the occurrence of an adverse cardiac event or for up to six months after delivery. The results from the separate sites will be combined to provide an overall assessment of the risk of serious cardiac events in users of domperidone.

Conditions

Ventricular Tachyarrhythmia; Sudden Cardiac Death; Lactation; Breast Feeding

Keywords

Domperidone; Postpartum; Ventricular Tachyarrhythmia; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• Ventricular tachyarrhythmia (VT) or sudden cardiac death (SCD)

  VT or SCD will be identified with the following ICD codes: VT: ICD-9 codes 427.1, 427.4x; ICD-10 codes I47.0, I47.2, I49.0x SCD: ICD-9 codes: V12.53, 427.5, 798.1, 798.2, 798.9; ICD-10 codes: Z86.74, I46.x, R99, R96.0, R96.1, R98 All potential SCD cases will be subjected to a computer algorithm to exclude non-relevant events (such as deaths occurring in hospital or due to non-cardiac pathology). At each site, computerized administrative records of potential SCD cases will be reviewed blinded to the exposure status to verify the accuracy of the algorithm. Finally, all potential cases that are not excluded by the algorithm will be manually reviewed in each site to ensure that all cases meet the event definition.

  Women will be followed from cohort entry until a diagnosis of VT or SCD, death, diagnosis of another indication for domperidone, end of healthcare coverage, or end of the study period (whichever occurs first), or for up to six months after delivery.

Secondary Outcomes (1)

• All-cause mortality

  Women will be followed from cohort entry until death from any cause, diagnosis of another indication for domperidone, end of healthcare coverage, or end of the study period (whichever occurs first), or for up to six months after delivery.

Study Arms (2)

Treated with domperidone

Women who received a prescription for domperidone during the six months following delivery.

Drug: Domperidone

Unexposed group (reference)

Women with no prescription for domperidone during the six months following delivery.

Drug: No domperidone

Interventions

Domperidone DRUG

Women who received a prescription for domperidone (ATC A03FA03) during the six months following delivery.

Also known as: ATC A03FA03

Treated with domperidone

No domperidone DRUG

Women with no prescription for domperidone during the six months following delivery.

Unexposed group (reference)

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

In each jurisdiction, the investigators will assemble a base cohort that includes all women aged between 15 and 55 years old with live births between April 1, 1997 and December 31, 2016 (or the latest available data at each site). Base cohort entry will be defined by the hospital discharge date after delivery. From this base cohort, a study cohort will be formed including all women who received a prescription for domperidone during the six months following delivery and matched women who have a physician visit at the same follow-up time and do not receive domperidone. Study cohort entry will be defined by the prescription date of domperidone for exposed women or the corresponding date of the physician visit for the unexposed women.

You may qualify if:

• Women aged between 15 and 55 years old with live births between April 1, 1997 and December 31, 2016 (or the latest available data at each site)

You may not qualify if:

• Women with less than 365 days of healthcare coverage prior to the start of pregnancy
• Women with a domperidone prescription in the year prior to or during pregnancy
• Women with a diagnosis of Parkinson's disease or other diseases that cause autonomic dysfunction or use of antiparkinsonian agents anytime before delivery
• Women with a diagnosis of gastroparesis in the year prior to or during pregnancy
• Women with a diagnosis of ventricular tachyarrhythmia in the year prior to or during pregnancy

Sponsors & Collaborators

• Canadian Network for Observational Drug Effect Studies, CNODES: lead
• Drug Safety and Effectiveness Network, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Lady Davis Institute for Medical Research, Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Related Publications (2)

• Suissa S, Moodie EE, Dell'Aniello S. Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores. Pharmacoepidemiol Drug Saf. 2017 Apr;26(4):459-468. doi: 10.1002/pds.4107. Epub 2016 Sep 9.

  PMID: 27610604 BACKGROUND

• Moriello C, Paterson JM, Reynier P, Dahl M, Aibibula W, Fisher A, Gamble JM, Kuo IF, Ronksley PE, Winquist B, Filion KB; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Off-label postpartum use of domperidone in Canada: a multidatabase cohort study. CMAJ Open. 2021 May 14;9(2):E500-E509. doi: 10.9778/cmajo.20200084. Print 2021 Apr-Jun.

  PMID: 33990364 BACKGROUND

Related Links

• This is the organization\'s website describing general functions, other CNODES projects, and investigator profiles.

MeSH Terms

Conditions

Tachycardia, Ventricular; Death, Sudden, Cardiac; Breast Feeding

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kristian B Filion, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 18, 2019
• Study Start: September 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 19, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)