Evidence map›Paper›PMID 28190780›Full record

ArticleJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2017

Pregnancy among cystic fibrosis women in the era of CFTR modulators.

Sonya L Heltshe, Emily M Godfrey, Tatiana Josephy, Moira L Aitken, Jennifer L Taylor-Cousar

Abstract read
In one paragraph

Article in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
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

19 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
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  5. Use of elexacaftor/tezacaftor/ivacaftor combination in pregnancy.Archives of gynecology and obstetrics · 2024
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Elexacafator/tezacaftor/ivacaftor resolves subfertility in females with CF: A two center case series.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Measured fetal and neonatal exposure to Lumacaftor and Ivacaftor during pregnancy and while breastfeeding.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2018
    Article
  19. Let's talk about sex: Behaviors, experience and health care utilization in young women with CF.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2018
    Article
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

5 authors.

Sonya L HeltsheUniversity of Washington School of Medicine, Department of Pediatrics, Division of Pulmonology, 4800 Sand Point Way NE, Seattle, WA 98105, USA; Seattle Children's Research Institute, Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, PO Box 5371, Seattle, WA 98145, USA. Electronic address: Sonya.Heltshe@Seattlechildrens.org.
Emily M GodfreyUniversity of Washington School of Medicine, Department of Family Medicine, 4311 11th Ave. NE, Seattle, WA 98105, USA; University of Washington School of Medicine, Department of Obstetrics and Gynecology, 4311 11th Ave. NE, Seattle, WA 98105, USA. Electronic address: godfreye@uw.edu.
Tatiana JosephyUniversity of Washington School of Medicine, Department of Family Medicine, 4311 11th Ave. NE, Seattle, WA 98105, USA; University of Washington School of Medicine, Department of Obstetrics and Gynecology, 4311 11th Ave. NE, Seattle, WA 98105, USA.
Moira L AitkenUniversity of Washington School of Medicine, Division of Pulmonary and Critical Care Medicine, 1959 N.E. Pacific, Campus Box 356522, Seattle, WA 98195-6522, USA. Electronic address: Moira@uw.edu.
Jennifer L Taylor-CousarNational Jewish Health Departments of Medicine and Pediatrics, Division of Pulmonary, Critical Care, and Sleep Medicine, 1400 Jackson St. Denver, CO 80206, USA. Electronic address: Taylor-CousarJ@NJHealth.org.

Funding

Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss, Lucas R Hoffman · 2010 to 2026
$21.4M
NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

backgroundLittle is known about how new therapies that partially correct the basic cystic fibrosis (CF) defect (ivacaftor and lumacaftor) might alter hormonal contraceptive effectiveness, impact pregnancy outcomes, or affect pregnancy timing. Examination of pregnancy rates among CF women during periods of CFTR modulator therapy initiation will provide foundation for further research in this area.

methodsThe Cystic Fibrosis Foundation Patient Registry was used to examine pregnancy rates and outcomes by genotype class before, during, and after the introduction of CFTR modulator therapies between 2005 and 2014.

resultsAmong women with CF, ages 15-44years, there was a slight downward trend in annual pregnancy rates from 2005 to 2014 (2% reduction per year, p=0.041). Among women with G551D, pregnancy rates during phase 3 ivacaftor trial years was 14.4/1000 women-years compared to 34.0/1000 prior to the trial period (relative risk [RR]=0.65; 95% CI=0.43-0.96; p=0.011) and 38.4/1000 after drug approval in June 2012 (RR=1.52 post-approval compared to trial period; 95% CI=1.26, 1.83; p<0.001). Pregnancy outcomes did not significantly change between 2005 and 2014 for any genotype class.

conclusionEvidence of significantly increased numbers of pregnancies among women taking approved CFTR modulators is important because of the unknown risk to pregnancy and fetal outcomes. Increases may be temporary following pregnancy prevention during controlled clinical trials, or from altered perceptions about maternal survival with new approved treatments. As more women with CF become eligible to receive modulators, the CF community must study their effect on contraceptive efficacy and safety during pregnancy. With increased health and survival due to modulation, family planning topics will become more common in CF.

Indexed as

Cystic FibrosisPregnancy ComplicationsAdolescentAdultAminophenolsAminopyridinesBenzodioxolesChloride Channel AgonistsCystic Fibrosis Transmembrane Conductance RegulatorFemaleHumansPregnancyPregnancy, High-RiskPregnancy OutcomePregnancy RateQuinolonesAminophenolsAminopyridinesBenzodioxolesChloride Channel AgonistsCystic Fibrosis Transmembrane Conductance RegulatorivacaftorlumacaftorQuinolonesG551DIvacaftorLumacaftorPregnancy

Identifiers

PMID28190780
PMCPMC5550358

What OpenQuestion holds

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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.