Consensus StatementThe Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy
Section snippets
Scope and Purpose
On review of the literature on IBD, specific questions about the management of IBD during pregnancy were identified and discussed by the participants. The guideline development process was initiated in July 2014 with the first meeting of the steering committee, and it lasted approximately 1 year; the full meeting of the consensus group took place in March 2015, and the final manuscript was submitted for publication in September 2015.
Sources and Searches
The editorial office of the Cochrane Upper Gastrointestinal
Recommendation Statements
The individual recommendation statements are provided and include the “GRADE” of supporting evidence and the voting results, after which a discussion of the evidence considered for the specific statement is presented. A summary of the recommendation statements is provided in Table 1.
Future Directions
Vedolizumab and ustekinumab are 2 relatively new options for the management of IBD. In a report of 24 vedolizumab-treated women who became pregnant during clinical trials, outcomes were known in 20 cases and included 10 live births (2 preterm), 1 congenital anomaly, 4 spontaneous abortions, and 5 elective terminations.146 Five case reports of pregnancy during ustekinumab treatment included one that resulted in miscarriage.147, 148, 149, 150, 151
Given the limited experience with vedolizumab and
Summary
These guidelines present recommendations for women with IBD during pregnancy, during the postpartum period, and while breast-feeding. Consensus was reached on 29 statements, and one statement was rejected. The statements focused on the impact of IBD during pregnancy, including the role of optimal disease management; medical management and the use of imaging, endoscopy, and surgery during pregnancy; and issues regarding delivery, breast-feeding, and vaccination of newborns of women with IBD (
Acknowledgments
The CAG would like to thank Janssen Inc. and Shire Canada for their generous support of the guideline process. The consensus group thanks the following people for their contributions: Paul Sinclair (obtaining funding, providing administrative and technical support, and representing the CAG), Dr William Paterson (consensus meeting moderator), Louise Hope (logistics assistance), Pauline Lavigne and Steven Portelance (unaffiliated, editorial assistance), Cathy Yuan (Cochrane Group), Nicole Talsma
References (224)
- et al.
Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review
Gastroenterology
(2012) - et al.
Mortality risk in preterm and small-for-gestational-age infants in low-income and middle-income countries: a pooled country analysis
Lancet
(2013) - et al.
Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus
Gastroenterology
(2015) - et al.
The AGA Institute process for developing clinical practice guidelines part one: grading the evidence
Clin Gastroenterol Hepatol
(2013) - et al.
Consensus statements on the risk, prevention, and treatment of venous thromboembolism in inflammatory bowel disease: Canadian Association of Gastroenterology
Gastroenterology
(2014) - et al.
Inflammatory bowel disease and pregnancy: lack of knowledge is associated with negative views
J Crohns Colitis
(2013) - et al.
Pregnancy and IBD treatment: this challenging interplay from a patients' perspective
J Crohns Colitis
(2010) - et al.
Preconception care in IBD women leads to less disease relapses during pregnancy (abstr Su1351)
Gastroenterology
(2014) - et al.
Crohn's disease is a risk factor for preterm birth
Clin Gastroenterol Hepatol
(2010) - et al.
Outcomes of obstetric hospitalizations among women with inflammatory bowel disease in the United States
Clin Gastroenterol Hepatol
(2009)
Maternal inflammatory bowel disease has short and long-term effects on the health of their offspring: a multicenter study in Israel
J Crohns Colitis
Pregnancy outcomes in women with inflammatory bowel disease: a large community-based study from Northern California
Gastroenterology
Complications from inflammatory bowel disease during pregnancy and delivery
Clin Gastroenterol Hepatol
Conception and pregnancy outcome in women with inflammatory bowel disease: a multicentre study from Japan
J Crohns Colitis
Medications as a potential source of exposure to phthalates among women of childbearing age
Reprod Toxicol
Efficacy of topical 5-aminosalicylates in preventing relapse of quiescent ulcerative colitis: a meta-analysis
Clin Gastroenterol Hepatol
Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysis
Reprod Toxicol
Limited risks of major congenital anomalies in children of mothers with IBD and effects of medications
Gastroenterology
American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-alpha biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease
Gastroenterology
The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: current management
J Crohns Colitis
A randomized, double-blind, controlled withdrawal trial in Crohn's disease patients in long-term remission on azathioprine
Gastroenterology
Long-term follow-up of babies exposed to azathioprine in utero and via breastfeeding
J Crohns Colitis
Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis
Gastroenterology
Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials
Clin Gastroenterol Hepatol
Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease
Clin Gastroenterol Hepatol
Effects of discontinuing anti-tumor necrosis factor therapy during pregnancy on the course of inflammatory bowel disease and neonatal exposure
Clin Gastroenterol Hepatol
Therapeutic infliximab drug level in a child born to a woman with ulcerative colitis treated until gestation week 31
J Crohns Colitis
Inflammatory bowel disease: a Canadian burden of illness review
Can J Gastroenterol
A meta-analysis on the influence of inflammatory bowel disease on pregnancy
Gut
Birth outcomes in women with inflammatory bowel disease: effects of disease activity and drug exposure
Inflamm Bowel Dis
Importance of appropriate pharmaceutical management in pregnant women with ulcerative colitis
BMC Res Notes
Relapses of inflammatory bowel disease during pregnancy: in-hospital management and birth outcomes
Am J Gastroenterol
Congenital abnormalities and other birth outcomes in children born to women with ulcerative colitis in Denmark and Sweden
Inflamm Bowel Dis
Meta-analysis: the impact of disease activity at conception on disease activity during pregnancy in patients with inflammatory bowel disease
Aliment Pharmacol Ther
The course of inflammatory bowel disease during pregnancy and postpartum: a prospective European ECCO-EpiCom Study of 209 pregnant women
Aliment Pharmacol Ther
The contribution of mild and moderate preterm birth to infant mortality. Fetal and Infant Health Study Group of the Canadian Perinatal Surveillance System
JAMA
Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule
Fed Regist
Treatment of hospitalized adult patients with severe ulcerative colitis: Toronto consensus statements
Am J Gastroenterol
The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease
J Crohns Colitis
GRADE: an emerging consensus on rating quality of evidence and strength of recommendations
BMJ
Going from evidence to recommendations
BMJ
Systematic review: fertility in non-surgically treated inflammatory bowel disease
Aliment Pharmacol Ther
Voluntary childlessness is increased in women with inflammatory bowel disease
Inflamm Bowel Dis
Fear and fertility in inflammatory bowel disease: a mismatch of perception and reality affects family planning decisions
Inflamm Bowel Dis
Impact of ileal pouch-anal anastomosis on female fertility: meta-analysis and systematic review
Int J Colorectal Dis
In vitro fertilization is successful in women with ulcerative colitis and ileal pouch anal anastomosis
Am J Gastroenterol
Pregnancy related issues in inflammatory bowel disease: evidence base and patients' perspective
World J Gastroenterol
Association between preconception counseling and folic acid supplementation before pregnancy and reasons for non-use
Matern Child Health J
Associations between preconception counseling and maternal behaviors before and during pregnancy
Matern Child Health J
Preconception care: screening and management of chronic disease and promoting psychological health
Reprod Health
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Conflicts of interest The authors disclose the following: Advisory Board: AbbVie (AB, CHS, GCN, JKM, CJV, LT, SF), AstraZeneca (JKM), Celltrion (JKM), Cubist (JKM), Ferring (AB, BB, JKM), Forest (JKM), Hospira (JKM), Janssen (AB, CHS, GCN, JKM, LT, SF), MSD (CJV), Procter & Gamble (JKM), Shire (AB, BB, CHS, JKM), Takeda (AB, CHS, JKM, LT).
Consultation Fees: AbbVie (BB, JJ, JKM, UM, YL), AstraZeneca (JKM), Celgene (UM), Celltrion (BB, JKM), Cubist (JKM), Ferring (JJ, JKM), Forest (JKM), Genentech (BB), Hospira (JKM), Janssen (AB, BB, CHS, JJ, JKM, UM, YL), Procter & Gamble (JKM), Prometheus (UM), Shire (AB, JJ, JKM, YL), Takeda (BB, JJ, JKM, UM, YL), UCB (UM).
Research Grants/Clinical Trial Funding: Amgen (BB), BI (BB), BMS (BB), Genentech (BB), GSK (BB), Janssen (CHS, CJV, YL), Redhill Pharma (BB), Pfizer (CHS, LT), Prometheus (UM), UCB (UM).
Speaker's Bureau: AbbVie (AB, BB, JJ, JKM, SF, YL), Aptalis (JKM), Falk Benelux (CJV), Ferring (BB, JJ, JKM), Forest (JKM), Janssen (BB, CHS, JJ, JKM, SF, YL), Pfizer (CHS, LT), Proctor & Gamble (JKM), Shire (BB, JJ, JKM, SF), Takeda (BB, JJ, JKM), Warner Chilcott (BB, CHS, JKM).
The remaining authors disclose no conflicts.
Funding Supported by unrestricted grants to the Canadian Association of Gastroenterology by Shire Canada and Janssen, which had no involvement in any aspect of guideline development.
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Authors share co-first authorship.