Evidence map›Paper›PMID 33227283›Full record

Observational studyGastroenterology2021

Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease.

Uma Mahadevan, Millie D Long, Sunanda V Kane, Abhik Roy, Marla C Dubinsky, Bruce E Sands, Russell D Cohen, Christina D Chambers, William J Sandborn, Crohn’s Colitis Foundation Clinical Research Alliance

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 111 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 6 pooled it
26.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00904878 recruitingnot on this map

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

TypeobservationalSponsorUniversity of California, San FranciscoRan2007 to 2028Enrolled1,500ConditionsInflammatory Bowel Disease
NCT05562726 unknown statusnot on this map

Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording

Typeobservational_patient_registrySponsorAlexandra Hospital, Athens, GreeceRan2020 to 2024Enrolled100ConditionsInflammatory Bowel Diseases, Pregnancy Related
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 6 syntheses or guidelines pooled it, 286 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Update on Pregnancy in Inflammatory Bowel Disease.Gastroenterology & hepatology · 2026
    Article
  14. Article
  15. Conception, pregnancy and inflammatory bowel disease-Current concepts for the practising clinician.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Review
  16. Pregnancy outcomes among women with inflammatory bowel disease: A UK tertiary centre experience.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
    Observational
  17. Article
  18. Article
  19. Review
  20. Review

51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

Uma MahadevanDivision of Gastroenterology and Hepatology, University of California San Francisco, San Francisco, California. Electronic address: uma.mahadevan@ucsf.edu.
Millie D LongDivision of Gastroenterology and Hepatology, Data Management Center, University of North Carolina, Chapel Hill, North Carolina.
Sunanda V KaneDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Abhik RoyDivision of Gastroenterology, Kaiser Permanente, San Leandro, California.
Marla C DubinskyDr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Bruce E SandsDr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Russell D CohenSection of Gastroenterology, Hepatology and Nutrition, University of Chicago, Chicago, Illinois.
Christina D ChambersDepartment of Pediatrics, University of California San Diego, La Jolla, California.
William J SandbornDivision of Gastroenterology and Hepatology, University of California San Diego, La Jolla, California.
Crohn’s Colitis Foundation Clinical Research Alliance
Icahn School of Medicine at Mount Sinai · USUniversity of California, San Diego · USKaiser Permanente San Leandro Medical Center · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of North Carolina at Chapel Hill · USWinnMed · US

Funding

UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Temitope O. Keku · 1985 to 2026
$30.5M
ULTRASTRUCTURE AND CYTOMORPHOLOGY COREP30DK042086 · NIDDK · UNIVERSITY OF CHICAGO · PI CHANG, EUGENE B · 1990 to 2025
$29.8M
Probing short and long term consequences of Small and Large Bowel Microbiota Transplants on Host Physiology: Implications for the development of future live biotherapeuticsR01DK138072 · NIDDK · UNIVERSITY OF CHICAGO · PI EUGENE B CHANG, Kristina Brooke Martinez-Guryn · 2024 to 2026
$2.1M
NIDDK NIH HHS P30 DK034987NIDDK NIH HHS P30 DK042086NIDDK NIH HHS P30 DK056350NIDDK NIH HHS R01 DK138072
6 · The paper itself

Abstract

BACKGROUND &

aimsPregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy, with health repercussions to mother and child.

methodsBetween 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States. The primary analysis was a comparison of 5 outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infant infections) among pregnancies exposed vs unexposed in utero to biologics, thiopurines, or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were used to determine the independent effects of specific drug classes on outcomes of interest.

resultsAmong 1490 completed pregnancies, there were 1431 live births. One-year infant outcomes were available in 1010. Exposure was to thiopurines (n = 242), biologics (n = 642), or both (n = 227) vs unexposed (n = 379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, low birth weight, and infections during the first year of life. Higher disease activity was associated with risk of spontaneous abortion (hazard ratio, 3.41; 95% confidence interval, 1.51-7.69) and preterm birth with increased infant infection (odds ratio, 1.73; 95% confidence interval, 1.19-2.51).

conclusionsBiologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or in the first year of life. Therapy with these agents can be continued throughout pregnancy in women with IBD to maintain disease control and reduce pregnancy-related adverse events. ClinicalTrials.gov, Number: NCT00904878.

Indexed as

Pregnancy OutcomeAdultAnti-Inflammatory AgentsAzathioprineBiological ProductsColitis, UlcerativeCrohn DiseaseDrug Therapy, CombinationFemaleHumansInfant, NewbornIntestinal MucosaMercaptopurinePregnancyPregnancy ComplicationsPrenatal Exposure Delayed EffectsAnti-Inflammatory AgentsAzathioprineBiological ProductsMercaptopurineCrohn’s DiseasePregnancyUlcerative Colitis

Identifiers

PMID33227283
PMCPMC7956164
OpenAlexW3102628359

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.