Evidence map›Paper›PMID 12524407›Full record

ArticleGut2003

Birth outcome in women exposed to 5-aminosalicylic acid during pregnancy: a Danish cohort study.

B Nørgård, K Fonager, L Pedersen, B A Jacobsen, H T Sørensen

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Gut, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05703425 (The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT05703425 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial

TypeinterventionalSponsorRutgers, The State University of New JerseyRan2023 to 2028Enrolled50ConditionsPreterm BirthArmsSulfasalazine
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 132 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Review
  5. Review
  6. Inflammatory bowel disease in pregnancy and breastfeeding.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  7. Article
  8. Review
  9. Review
  10. Managing IBD Therapies in Pregnancy.Current treatment options in gastroenterology · 2017
    Review
  11. Treatment of pregnant women with a diagnosis of inflammatory bowel disease.World journal of gastrointestinal pharmacology and therapeutics · 2016
    Review
  12. Managing inflammatory bowel disease in pregnancy: current perspectives.Clinical and experimental gastroenterology · 2016
    Review
  13. Article
  14. Review
  15. Crohn's disease in women.International journal of women's health · 2013
    Review
  16. Review
  17. Article
  18. Pros and cons of medical management of ulcerative colitis.Clinics in colon and rectal surgery · 2010
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

B NørgårdDepartment of Clinical Epidemiology, Aarhus University Hospital, DK-8000 Aarhus C, Denmark. bn@soci.au.dk
K Fonager
L Pedersen
B A Jacobsen
H T Sørensen
Aarhus University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background5-Aminosalicylic acid (5-ASA) preparations are the firstline drugs in the treatment of inflammatory bowel disease. Data on the safety of these drugs in pregnancy are sparse.

aimsTo examine the risk of adverse birth outcome in women who were prescribed 5-ASA drugs during pregnancy. PATIENTS: Women were included in the study if they were prescribed 5-ASA drugs immediately before or during pregnancy. To examine the risk of malformations, we included 60 pregnancies exposed to 5-ASA drugs 30 days before pregnancy or in the first trimester. To examine stillbirths, preterm births, and low birth weight, we included 88 pregnancies exposed during the entire pregnancy. Outcomes were compared with those of 19 418 pregnancies in which no drugs were prescribed for mothers during the study period.

methodsWe conducted a Danish cohort study based on data from a population based prescription registry, the Danish Birth Registry, and the Hospital Discharge Registry in North Jutland County.

resultsOdds ratios for malformations, stillbirth, preterm birth, and low birth weight in women who received prescriptions for 5-ASA drugs were 1.9 (95% confidence interval 0.7-5.4), 6.4 (1.7-24.9), 1.9 (0.9-3.9), and 1.2 (0.4-3.3), respectively. The increased risk of stillbirth and preterm birth were found only in patients with ulcerative colitis.

conclusionsWe found an increased risk of stillbirth and preterm birth in women who had been prescribed 5-ASA drugs during pregnancy but no substantial increased risk of malformations. It was difficult to distinguish the specific effects of disease activity and 5-ASA drugs.

Indexed as

Abnormalities, Drug-InducedAdultAnti-Inflammatory Agents, Non-SteroidalCohort StudiesColitis, UlcerativeCrohn DiseaseDenmarkFemaleFetal DeathGestational AgeHumansInfant, Low Birth WeightInfant, NewbornInfant, PrematureMaleMesalamineAnti-Inflammatory Agents, Non-SteroidalMesalamine

Identifiers

PMID12524407
PMCPMC1774957
OpenAlexW2130644721

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.