Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix
Rattachement africain : us, jp, Cameroun. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Importance: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting. Objective: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix. Design, Setting, and Participants: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded. Interventions: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians. Main Outcome and Measures: The primary outcome was delivery or fetal death prior to 37 weeks. Results: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32). Conclusions and Relevance: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT02901626.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix
- Date Crossref
- 25/07/2023
- Éditeur
- American Medical Association (AMA)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Columbia University Department of Obstetrics and Gynecology pays non établi dans la noticeUniversité ou école supérieure
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George Washington University pays non établi dans la noticeUniversité ou école supérieure
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University of Alabama at Birmingham pays non établi dans la noticeUniversité ou école supérieure
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The University of Texas Medical Branch at Galveston pays non établi dans la noticeUniversité ou école supérieure
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Eunice Kennedy Shriver National Institute of Child Health and Human Development pays non établi dans la noticeStructure de recherche
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University of North Carolina at Chapel Hill pays non établi dans la noticeUniversité ou école supérieure
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Northwestern University pays non établi dans la noticeUniversité ou école supérieure
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National Center For Child Health and Development pays non établi dans la noticeOrganisme public
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Health and Human Development (2HD) Research Network Cameroun (code pays fourni par la source)Institution
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The Ohio State University pays non établi dans la noticeUniversité ou école supérieure
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Memorial Hermann pays non établi dans la noticeÉtablissement de santé
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Hospital of the University of Pennsylvania pays non établi dans la noticeÉtablissement de santé
Department of Obstetrics and Gynecology — Columbia University, George Washington University et University of Alabama at Birmingham, avec 9 autres affiliations. Pays d’affiliation : Cameroun.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.