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Record W2790217653 · doi:10.1093/jcag/gwy009.104

A104 PREGNANCY OUTCOMES IN WOMEN WITH INFLAMMATORY BOWEL DISEASE AND EXPOSURE TO BIOLOGICS - A PROSPECTIVE COHORT STUDY

2018· article· en· W2790217653 on OpenAlexaffabout
S Wang, Juan Nicolás Peña-Sánchez, Sharyle Fowler

Bibliographic record

VenueJournal of the Canadian Association of Gastroenterology · 2018
Typearticle
Languageen
FieldMedicine
TopicPregnancy and Medication Impact
Canadian institutionsUniversity of Saskatchewan
Fundersnot available
KeywordsMedicinePregnancyVedolizumabAdalimumabInflammatory bowel diseaseProspective cohort studyInfliximabUlcerative colitisUstekinumabCrohn's diseaseObstetricsInternal medicinePopulationCohortDisease

Abstract

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Inflammatory bowel disease (IBD) has a peak incidence rate in women of reproductive age. Biologic agents are commonly used in IBD management. However, prospective safety data on biologics exposure in the pregnant population remain limited. To assess baseline differences, and to compare obstetrical and neonatal outcomes in women with IBD who are exposed and non-exposed to biologics during pregnancy. Since November 2014, pregnant women with ulcerative colitis (UC) or Crohn’s disease (CD) were enrolled in a prospective registry. Patients were assessed every trimester, and at three, six, and 12-months post-partum. Disease activity, pregnancy complications, and delivery and newborn outcomes were recorded. Women were divided into exposed (adalimumab [ADA], infliximab [IFX], vedolizumab [VDZ], or ustekinumab [UST]) and non-exposed (no medications or 5-aminosalicylic acid [5-ASA]) groups. Patients taking only immunomodulators were excluded. Mann–Whitney U and Fisher’s exact tests were used to identify differences between groups. To date, 36 patients have been enrolled in the study, totalling 38 pregnancy events. Sixteen pregnancy events were exposed to biologics: 9 (56.2%) ADA, 4 (25.0%) IFX, 2 (12.5%) VDZ, 1 (6.2%) UST. Twenty-two pregnancy events were not exposed: 8 (36.4%) 5-ASAs and 14 (64.6%) no medications. Within the exposed and non-exposed groups, 13 (81.3%) and 14 (63.6%) women had CD, respectively. The exposed group had fewer patients with a smoking history (1 [6.3%] vs 11 [50.0%], p=0.04), while a higher proportion had an annual household income above $100,000 (11 [78.6%] vs 7 [35.0%], p=0.012). No differences were observed between groups for adverse pregnancy diagnoses (gestational hypertension and diabetes, preeclampsia/eclampsia), post-partum infections, and neonatal outcomes (low birth weight, prematurity, and infections). Disease relapse during pregnancy (5 [31.3%] vs 8 [36.4%], p=0.74) and steroid use (4 [25%] vs 3 [13.6%], p=0.42) were similar between exposed and non-exposed groups, respectively. Caesarian section (CS) occurred in 7 (46.7%) of exposed and 10 (62.5%) of non-exposed group (p=0.38), while 6 (16.7%) patients in total had active perianal disease. There was a trend towards significance for increased emergency CS within the non-exposed (6 [37.5%]) compared to exposed group (1 [6.7%], p=0.08). No significant difference was observed for breast feeding rates between groups. Biologics exposure does not appear to be associated with adverse pregnancy and neonatal outcomes. Higher socioeconomic status was linked to women using biologics during pregnancy. A high CS rate was also observed overall while few had an IBD-related indication. Future studies should explore any barriers to accessing biologics in Canada, and the propensity for CS in women with IBD. Saskatchewan Health Research Foundation (SHRF)

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.003
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.010

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.003
Meta-epidemiology (narrow)0.0000.001
Meta-epidemiology (broad)0.0000.001
Bibliometrics0.0010.002
Science and technology studies0.0010.000
Scholarly communication0.0010.001
Open science0.0000.001
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0030.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.006
GPT teacher head0.240
Teacher spread0.234 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations1
Published2018
Admission routes2
Has abstractyes

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