CFI funds major study of the health impact of medications taken during pregnancy

Padma Kaul, PhD

A University of Alberta researcher and collaborators in four other provinces have launched a groundbreaking Canadian initiative to investigate the impact of prescription drug use during pregnancy on long-term health outcomes for mothers and children.

The Canada Foundation for Innovation (CFI) is contributing almost $1.2 million toward the project, called the Canadian Mother-Child Cohort (CaMCCo) Active Surveillance Program. Quebec will host the cohort’s co-ordinating centre, under the leadership of University of Montreal’s Anick Bérard, a world leader in this field.

In Alberta, the project will be led by U of A cardiology professor and epidemiologist Padma Kaul. For the CFI-funded initiative, she joins researchers in Ontario, Manitoba, Saskatchewan and Quebec.

Evidence suggests that 75 per cent of expectant mothers take at least one medication during their pregnancy, a number that initially surprised Kaul. But, she explains, this may be due in part to many women delaying childbirth until they are older and therefore having more pre-existing medical conditions that require prescription drugs at the time of pregnancy. And much of the medication use may occur in the first trimester, when a woman may not even know she is pregnant.

There is currently little data on the safety and efficacy of medications taken during pregnancy, including their effect on the developing fetus and long-term repercussions for the health of the mother and child. Pregnant women are excluded from randomized clinical trials of new drugs because of concerns about potential harm to the fetus, so longitudinal, observational studies often offer the best level of evidence in this population.

Kaul’s team has been collecting data on a cohort of mothers and children in Alberta for 10 years, tracking what drugs the mothers took during pregnancy (based on medication claims submitted to pharmacies). They have used these data to look at gestational diabetes, birth outcomes, childhood obesity and other health issues.

Similar cohorts are being created in other provinces, with Quebec leading the way by gathering data going back to 1998. The CaMCCo project will develop standardized tools and definitions across the provincial cohorts, allowing the group to create a database that will have access to about four million pregnancies and three million children, going back to 1998.

This would make it one of the biggest cohorts of mothers and children in the world. CaMCCo collaborators, who met last year in Montreal just before the COVID-19 pandemic began, would like to eventually unite cohort studies from all Canadian provinces.

The researchers plan to focus first on two frequently used drugs─antidepressants and opioids─and include other drugs as the program evolves. They will be looking for information on prematurity, low birth weight, autism, attention deficit disorders and rare malformations, as well as prenatal and postpartum health issues for the mothers.

Kaul, who is a member of the Women and Children’s Health Research Institute (WCHRI), hopes that the database and infrastructure developed as part of CaMCCo will serve as a resource for the larger WCHRI research community as well as Alberta family physicians and obstetricians who provide care for expectant mothers.

“I see the clinicians as partners. Not only will they be the end users of this information, but I also see them as generators of the questions that need answering with these data.”

Ultimately, Kaul hopes CaMCCo becomes a resource that public health agencies in Canada and around the world turn to when looking for information on the impact of medication use during pregnancy. “If the evidence is consistent across five provinces, it would make it much stronger.”