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Retrospective observational cohort study of fertility intentions and of outcomes among women exposed to anti-TNF-α therapy for Inflammatory Bowel Disease (IBD).

Project: Research

  • Julsgaard, Mette (Project manager)
  • Christensen, Lisbet Ambrosius (Project manager)
  • Fallingborg, J. (Collaborator)
  • Kjeldsen, Jens (Collaborator)
  • Bell, Sally (Collaborator)
  • Gearry, Richard (Collaborator)
  • Gibson, Peter (Participant)
  • Andrews, Jane (Participant)
  • Connor, Susan (Participant)
  • Walsh, Alissa (Participant)
  • Lawrence, Ian (Participant)
  • Radford-Smith, Graham (Participant)
  • Moore, Greg (Participant)
  • Bampton, Peter (Participant)
  • Gastromedicinsk afdeling, Odense Universitets Hospital
  • St. Vincents hospital, Melbourne
  • ChristChurch University Hospital, ChristChurch
  • Dept. of Gastroenterology, Alfred Hospital, Melbourne, VIC
  • Royal Adelaide Hospital, Adelaide, SA
  • 8Dept. of Gastroenterology, Liverpool Hospital, Sydney, NSW
  • 9Dept. of Gastroenterology, St. Vincent’s Hospital, Sydney, NSW
  • Dept. of Gastroenterology, Fremantle Hospital, Fremantle, WA
  • Dept. of Gastroenterology, Royal Brisbane Hospital, Queensland
  • Dept. of Gastroenterology, Flinders Medical Center, SA
See relations at Aarhus University


Inflammatory bowel disease’s (IBD) are idiopathic, chronic inflammatory diseases of the intestine. The peak age of incidence of IBD in Denmark, Australia and New Zealand between 20-30 is during maximum fertility. Clinical remission in IBD is important for the outcome of pregnancy. To induce and maintain remission, medical treatment is often needed during both asymptomatic and symptomatic stages of the disease.
Active disease at the time of conception seems to be the main factor predisposing to adverse pregnancy outcomes such as premature delivery, low birth weight and stillbirth. Physicians often recommend their patients with active disease to avoid pregnancy, although IBD patients may have an active pregnancy wish.
Anti Tumour Necrosis Factor Alfa antibodies (Anti TNF-α), are now used early in the course of aggressive IBD that fails to settle with conventional medical therapy. With anti-TNF-α therapy it has become possible to rapidly induce and maintain remission. This improved therapy of IBD makes it possible to women to consider pregnancy, but concerns regarding the use of drugs during pregnancy and lactation are often raised by IBD patients.
Anti-TNF-α therapy is classified as category B agents (no documented human toxicity in pregnancy). Small series have suggested there is no increase in adverse outcomes or congenital anomalies. However, data on the safety of Anti-TNF-α therapy at conception, during pregnancy and lactation is limited.
Many clinicians from Denmark, Australia and New Zealand are continuing Anti-TNF-α therapy during pregnancy and the number of women in theses agents conceiving and delivering is increasing.
The usual approach to therapy in this situation and the outcomes of current practice in Denmark, Australia and New Zealand are unknown.
1. That current practice is to recommend women who conceive on Anti-TNF-α continue the treatment through the first two trimesters.
2. That Anti-TNF-α exposure at conception and during pregnancy is not associated with adverse pregnancy outcomes, including congenital anomalies, in women receiving these drugs for moderate-severe IBD.
1. To retrospectively describe the outcomes of pregnancies in women with IBD exposed to Anti-TNF-α around the time of pregnancy, divided into exposure groups.
2. To assess the experiences and risk perceptions of women with IBD receiving Anti-TNF-α during pregnancy
Women with IBD who have had a pregnancy and been treated with Anti-TNF-α will be recruited from major IBD centers in Denmark, Australia and New Zealand. Identified data will be collected from the women, their treating gastroenterologist, and if required, their obstetrician. Specific data collected will include date of birth, diagnosis, medical treatment, complication’s during pregnancy, pregnancy outcome, birthweight, congenital anomalies, breastfeeding practices, mother’s concerns, counseling regarding medical treatment, the child’s growth centile and vaccination compliance.
All enrolled women will receive an electronic questionnaire after pregnancy and when their child is one year old. The women will be surveyed about their pregnancy experiences and outcomes. Gastroenterologists in major centers in Australia and New Zealand will receive an electronic questionnaire regarding prescribing practice of Anti-TNF-α.
Effective start/end date01/02/201231/07/2018

ID: 128983273