Evidence map›Paper›PMID 28441992›Full record

Observational studyAllergy and asthma proceedings2017

Safety of a C1-inhibitor concentrate in pregnant women with hereditary angioedema.

James Fox, Arthur B Vegh, Inmaculada Martinez-Saguer, Walter A Wuillemin, Jonathan Edelman, Debora Williams-Herman, Mikhail Rojavin, Tanja Rosenberg

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Allergy and asthma proceedings, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.1field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 36 citations in OpenAlex.

  1. The International/Canadian hereditary angioedema guideline.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2026
    Review
  2. Review
  3. Considerations in the management of hereditary angioedema due to C1-INH deficiency in women of childbearing age.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Review
  4. Article
  5. Review
  6. Article
  7. Hereditary Angioedema Attack in Utero and Treatment of the Mother and Fetus.Mayo Clinic proceedings. Innovations, quality & outcomes · 2020
    Article
  8. Peanuta non grata revisited.Allergy and asthma proceedings · 2019
    Article
  9. Allergy and asthma proceedings · 2019
    Article
  10. Article
  11. Article
  12. Article
  13. The International/Canadian Hereditary Angioedema Guideline.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2019
    Review
  14. Review
  15. Article
  16. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

James Fox
Arthur B Vegh
Inmaculada Martinez-Saguer
Walter A Wuillemin
Jonathan Edelman
Debora Williams-Herman
Mikhail Rojavin
Tanja Rosenberg

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncreased estrogen levels during pregnancy can exacerbate hereditary angioedema (HAE), yet disease and treatment ramifications remain poorly studied in pregnant women.

objectiveData from the international Berinert Patient Registry were used to evaluate outcomes of pregnancies exposed to plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH) during routine HAE management.

methodsThis observational registry, conducted between 2010 and 2014 at 30 U.S. and 7 European sites, gathered data on 318 subjects and 15,000 pnfC1-INH infusions. Whenever possible, the subjects who used pnfC1-INH during pregnancy were followed up to term to assess neonatal outcomes and to collect maternal adverse events (AE) that occurred up to 1 month after pnfC1-INH administration.

resultsThe registry data base included 11 pregnancies in 10 subjects who used pnfC1-INH for HAE attack treatment and/or prophylaxis (>261 doses during pregnancy). Eight pregnancies concluded in the birth of a healthy baby. Of the remaining three pregnancies: one was voluntarily terminated at 9 weeks of gestation; a second ended as a first-trimester spontaneous abortion 1 week after the subject's most recent pnfC1-INH infusion and was considered unrelated to pnf-C1INH treatment; and the third occurred in a subject who exited the registry approximately 2 months before her due date, with no further follow up. As assessed for 30 days after each pnfC1-INH infusion, there were no AEs that were considered related to pnfC1-INH therapy.

conclusionAdministration of pnfC1-INH during pregnancy was generally safe and not associated with any treatment-related AEs. In all registry pregnancies followed up to term, the birth of a healthy baby was reported.

Indexed as

AdultAngioedemas, HereditaryComplement C1 Inhibitor ProteinFemaleHumansPregnancyPregnancy Complications, CardiovascularPregnancy OutcomeRegistriesYoung AdultComplement C1 Inhibitor Protein

Identifiers

PMID28441992
OpenAlexW2609540741

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.