Data providing answers about taking medication during pregnancy
The Canadian Mother-Child Cohort Active Surveillance Initiative is bringing together data from across Canada to advance the understanding about the risks and benefits of medication for expectant mothers. istock.com
A Canadian research partnership is aiming to better understand the risks and benefits of taking medication during pregnancy to address acute or chronic health concerns.
While a vast majority of women take medications during pregnancy, a lack of evidence from clinical trials, from which pregnant women are typically excluded, means definitive data on the impacts of drugs on maternal and fetal health is often scarce.
Researchers are now confident, however, that an effort to collect, validate and harmonize relevant health-care information from across Canada will help to fill this crucial knowledge gap.
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Building a national platform is key – not only for mothers and health-care providers but also for decision-makers at the national and provincial levels. ”
“Statistics show that more than 75 per cent of pregnant women in Canada take medication, and evidence-based guidance on whether to advise them to continue or stop taking medications is urgently needed,” says Sherif Eltonsy, research scientist at the College of Pharmacy, Rady Faculty of Health Sciences and Children’s Hospital Research Institute of Manitoba. “Adverse drug events are very rare in pregnancy and might happen well after the child is born, so we need big data sets.”
Dr. Eltonsy co-leads the Canadian Mother-Child Cohort (CaMCCo) Active Surveillance Initiative with Anick Bérard of the Université de Montréal and the Sainte-Justine Health Centre, and the co-investigators recently received $2.9-million in funding support from the Canada Foundation for Innovation.
Health-care information exists across Canada, but it is currently siloed in each province, explains Dr. Eltonsy. “You could have records of 100 pregnant women using a particular medication in Manitoba, 200 in Quebec and different numbers in other provinces. Bringing the data together will allow us to find signals of any adverse effects for the short term and the long term. What makes this effort unique is that we have longitudinal databases in Canada.”
Quebec alone has 17 years’ worth of data on 450,000 pregnancies in the province, which links medication use at various stages of pregnancy with outcomes. When complete, the CaMCCo program will be unique for its validated data – and decades’ worth of information, says Dr. Bérard. “A little girl in our database born in 1998 could have a child in our database.”
Beyond creating province-specific databases for a total of over four million mothers and children with up to 22 years of follow-up, the project will build a country-wide database of existing data from Quebec, Ontario, Manitoba, Saskatchewan and Alberta (in collaboration with the University of Ottawa, the University of Saskatchewan and the University of Alberta).
As a key focus for the state-of-the-art data infrastructure, the research team will work to ensure that the information is accurate, says Dr. Eltonsy. “In order to gain robust insights, the data has to be collected in a systematic way as well as validated and harmonized. We are working with analysts with expertise in checking data quality.”
The project will follow women who go through pregnancies – and their children – over a number of years to assess outcomes that may develop long after the primary exposure, he notes. “For example, symptoms for ADHD or autism may be recognized later in a child’s life, and in order to map trends, we require a large sample size from across the country.”
Initially, the study will focus on opioids and antidepressants, but there are many pressing questions the database can potentially help to address. Dr. Bérard, for example, has observed the need to investigate antiepileptic medications. “We know pregnant women with epilepsy will sometimes stop their medication because they’re afraid for their baby,” she says.
For Dr. Eltonsy, the effort has the potential to catalyze a world-class active research and surveillance program in perinatal pharmaco-epidemiology. “Researchers can request access to our data,” he says. “And we can provide content, database and analysis expertise to help them reach their goals.”
There are many examples where Health Canada and other provincial health agencies can benefit from rapid analyses of administrative data for decision-making purposes, Dr. Eltonsy says. “Building a national platform is key – not only for mothers and health-care providers but also for decision-makers at the national and provincial levels.”
By quantifying the risks and benefits of prescription drug use during pregnancy on short- and long-term maternal and child health outcomes, the initiative can help to provide valuable insights for boosting community health, he adds.
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