Changing the Paradigm of IBD Care for Women Considering Motherhood

Women with Crohn’s disease and ulcerative colitis (UC) are often diagnosed during peak childbearing years, raising a host of wrenching questions and doubts in their minds around fertility and pregnancy. Unfortunately, physicians are typically short on answers, forced to rely on retrospective data and registries that fail to adequately assess their patients’ risk of complications and adverse outcomes as they look to start or grow their families.

Mount Sinai is launching an ambitious study to change that paradigm by providing accurate and high-quality data to counsel inflammatory bowel disease (IBD) patients on the impact that factors such as surgery, medications, and disease activity might have on their ability to conceive. The Women With Inflammatory Bowel Disease and Motherhood (WIsDoM) study, funded by a $1.7 million award from the Helmsley Charitable Trust, has engaged some 30 sites across the country that are recruiting women with IBD who are planning to become pregnant.

“For the first time in the history of the disease, we’ll be able to answer with confidence such basic questions as whether women with IBD could have more difficulty conceiving or, conversely and hopefully, if they’ll have no more difficulty than the general population,” says Marla Dubinsky, MD, Professor of Medicine (Gastroenterology), and Pediatrics, at the Icahn School of Medicine at Mount Sinai; Co-Director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai; and a co-Principal Investigator of the study. “If we’re able to know that a woman has or will have specific fertility issues, then we’d be able to send her early to our fertility partners or reproductive endocrinologists, rather than having her wait months or years to get specialized help.”

Women with IBD are known to be at greater risk for fertility and pregnancy complications. Past research suggests, for example, that active inflammation from Crohn’s disease and UC may impact the ability to get pregnant, and that active disease is a major risk factor for miscarriage. More specifically, literature shows that a woman with UC who has had her colon removed via open surgery is at three to five times greater risk of infertility. Moreover, roughly 17 percent of women with IBD voluntarily remain childless (versus 6 percent of the general population) out of fears over the safety of the medicines they’re taking, the impact of IBD on their pregnancy and vice versa, and the possibility of passing their disease down to their children.

The Mount Sinai researchers believe results from their study can go a long way to reassure women while they are trying to become pregnant, and even debunk some of their worst fears through reliable and updated information.

To that end, a primary goal of researchers is to develop, test, and validate a novel risk prediction calculator for infertility. “Through this model, we’ll be able to plug in a woman’s risk factors and health history to determine how they independently and cumulatively affect her fertility,” explains Zoë Gottlieb, MD, Assistant Professor of Medicine (Gastroenterology) at the Icahn School of Medicine, and co-Principal Investigator of the study. “We’ll also be looking at the impact of laparoscopic versus open IBD surgery on fertility, as well as the effects of other potential risk factors such as a patient’s IBD subtype and phenotype, extent and duration of their disease, medication history, and social determinants of health.”

Prior studies have focused on the impact of open J-pouch surgery in UC on female fertility, with minimal exploration of the effects of a laparoscopic approach, now much more common. Additionally, it is believed no previous research has examined the impact of other types of IBD surgery, particularly laparoscopic and open, on fertility within this patient population.

From this inquiry, Dr. Dubinsky points out, information will emerge that not only helps women make the right decisions, but their providers as well, including OB/GYNs and colorectal surgeons who need to be equipped to counsel IBD patients on the magnitude of risk and types of clinical issues they’ll face on the road to motherhood. “We hope our findings will significantly impact the way women are counseled about family planning, both pre- and postoperatively,” she says.

Dr. Gottlieb sees another significant benefit emanating from the Helmsley-funded research. “We feel very confident we’ll be able to apply results from our study to our clinical practice almost immediately,” she says, “and that it will provide a platform for meaningful change in the way we care for all our IBD patients.”