Development of the First Global Guidelines for Managing Pregnancy in Women with Inflammatory Bowel Disease

Recent advancements have led to the formulation of the world's first comprehensive, evidence-based guidelines to optimize care for pregnant women with inflammatory bowel disease (IBD). Historically, managing IBD during pregnancy was challenging due to limited data on how medications affect both maternal health and fetal development, often leaving clinicians and patients uncertain about best practices.

Because pregnant women are typically excluded from clinical trials of new IBD therapies, much of the current understanding relies on animal safety data or post-marketing surveillance, which leaves gaps in knowledge about human pregnancy outcomes. Discontinuing medications during pregnancy can lead to disease flare-ups, increasing the risk of complications for both mother and child. Despite these risks, many healthcare providers continue to face uncertainties regarding the safety of specific drugs.

To address these concerns, the Helmsley PIANO (Pregnancy Inflammatory Bowel Disease and Neonatal Outcomes) Expert Global Consensus was assembled. This international panel of specialists, including gastroenterologists, maternal-fetal medicine experts, and patient advocates, reviewed existing literature to develop standardized, practical recommendations for treatment and care during pregnancy. The guidelines emphasize the importance of preconception counseling, aiming for women to achieve and maintain remission for three to six months before conception.

Key recommendations include continuing low-risk medications such as 5-aminosalicylic acids (5-ASAs), sulfasalazine, thiopurines, and monoclonal antibodies throughout pregnancy and breastfeeding. For drugs with less established safety profiles, such as small molecule therapies, the guidelines advise caution and possible discontinuation before conception. Notably, women with IBD can breastfeed safely while on biologic therapies, including newer IL-23 inhibitors, based on physiological evidence rather than clinical trial data.

Prophylactic interventions also feature prominently, with the consensus endorsing the initiation of low-dose aspirin between weeks 12-16 of pregnancy to lower the risk of preterm preeclampsia. Additionally, vigilant monitoring for venous thromboembolism (VTE) risk is recommended, along with administering the rotavirus vaccine to infants regardless of in utero exposure to IBD medications.

These guidelines aim to provide a globally applicable framework, considering diverse healthcare settings, and incorporate patient perspectives to ensure recommendations are patient-centered. The overarching goal is to foster hope and provide reassurance to women with IBD, promoting optimal pregnancy outcomes and healthy infants.

The landmark PIANO study and the consensus encompass data from over 2,200 pregnancies, revealing that while certain medications like steroids may be associated with adverse outcomes such as preterm birth, they are often markers of active disease rather than direct causes. Importantly, there is no evidence linking IBD medications to increased birth defects or impaired brain development, with infants generally developing normally, even when exposed in utero.

By synthesizing expert knowledge and current research, these guidelines serve as a crucial resource for clinicians worldwide, ensuring women with IBD receive consistent, high-quality care from preconception through postpartum, ultimately improving maternal and neonatal health outcomes.