دورية أكاديمية
PROMPT: Prospective Meta-analysis for Pessary Trials Study Protocol.
| العنوان: | PROMPT: Prospective Meta-analysis for Pessary Trials Study Protocol. |
|---|---|
| المؤلفون: | Thom EA; The George Washington University Biostatistics Center, Washington, District of Columbia., Saade GR; Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas., Askie LM; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia., Ugwu LG; The George Washington University Biostatistics Center, Washington, District of Columbia., Mol BWJ; Department of Obstetrics and Gynecology, Monash University, Monash, Australia., Vayssiere C; Department of Obstetrics and Gynecology, Toulouse III University, Toulouse, France., Norman JE; University of Nottingham, Nottingham, United Kingdom., Pajkrt E; Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands., Clifton RG; The George Washington University Biostatistics Center, Washington, District of Columbia., Biggio JR; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama., Arnaud C; Department of Obstetrics and Gynecology, Toulouse III University, Toulouse, France., Berghella V; Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania., Canino MG; Department of Obstetrics and Gynaecology, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Carreras E; Department of Obstetrics and Gynaecology, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Dugoff L; Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania., Hoffman MK; Department of Obstetrics and Gynecology, Columbia University, New York, New York., Pacagnella RC; Department of Obstetrics and Gynecology, State University of Campinas-UNICAMP, São Paulo, Brazil., Reddy UM; Division of Extramural Research Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland., Saccone G; Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy., Hooft JV'; Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands., Dang VQ; Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Vietnam. |
| مؤلفون مشاركون: | Prospective Meta-analysis for Pessary Trials Collaboration |
| المصدر: | American journal of perinatology [Am J Perinatol] 2024 May; Vol. 41 (S 01), pp. e2230-e2237. Date of Electronic Publication: 2023 Jul 10. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Thieme-Stratton Country of Publication: United States NLM ID: 8405212 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1098-8785 (Electronic) Linking ISSN: 07351631 NLM ISO Abbreviation: Am J Perinatol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Thieme-Stratton, 1983- |
| مواضيع طبية MeSH: | Pessaries* , Premature Birth*/prevention & control, Humans ; Female ; Pregnancy ; Prospective Studies ; Cervix Uteri ; Randomized Controlled Trials as Topic ; Meta-Analysis as Topic ; Pregnancy, Twin ; Infant, Newborn ; Research Design |
| مستخلص: | Objective: Preterm birth, defined as birth before 37 weeks of gestation, is a leading cause of perinatal and infant mortality throughout the world. Preterm birth is also associated with long-term neurological disabilities and other significant health issues in children. A short cervix in the second trimester has been noted to be one of the strongest predictors of subsequent spontaneous preterm birth in both singleton and multiple pregnancies. Some studies have shown that cervical support in the form of an Arabin pessary lowers the risk of preterm birth in women with a singleton gestation and short cervical length; however, other studies have conflicting results. Our objective was to form an international collaborative of planned or ongoing randomized trials of pessary in singleton and twin gestations with a short cervix. Study Design: In November 2014, an international group of investigators, who had initiated or were planning randomized trials of pessary for pregnant people with a short cervix and singleton or twin gestation to prevent preterm birth, formed a collaboration to plan a prospective individual patient data (IPD) meta-analysis of randomized trials (PROspective Meta-analysis of Pessary Trials [PROMPT]). The PROMPT investigators agreed on meta-analysis IPD hypotheses for singletons and twins, eligibility criteria, and a set of core baseline and outcome measures. The primary outcome is a composite of fetal death or preterm delivery before 32 weeks' gestation. Secondary outcomes include maternal and neonatal morbidities. The PROMPT protocol may be viewed as a written agreement among the study investigators who make up the PROMPT consortium (PROSPERO ID# CRD42018067740). Results: Results will be published in phases as the individual participating studies are concluded and published. Results of the first phase of singleton and twin pessary trials are expected to be available in late 2022. Updates are planned as participating trials are completed and published. Key Points: · Short cervical length predicts preterm birth.. · Results of prior cervical pessary trials are mixed.. · Meta-analysis of pessary trials protocol.. Competing Interests: None declared. (Thieme. All rights reserved.) |
| References: | J Perinat Med. 2003;31(2):122-33. (PMID: 12747228) Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. (PMID: 22284156) Am J Perinatol. 2013 Apr;30(4):283-8. (PMID: 22875662) Obstet Gynecol. 2005 Jul;106(1):181-9. (PMID: 15994635) Obstet Gynecol. 2016 Jan;127(1):49-58. (PMID: 26646133) Lancet. 2015 Jan 31;385(9966):430-40. (PMID: 25280870) Reprod Health. 2013;10 Suppl 1:S2. (PMID: 24625129) Obstet Gynecol. 2012 Jun;119(6):1308-17. (PMID: 22617615) Am J Obstet Gynecol. 1990 Sep;163(3):859-67. (PMID: 2206073) Ultrasound Obstet Gynecol. 2022 Feb;59(2):263-266. (PMID: 34941003) N Engl J Med. 2016 Mar 17;374(11):1044-52. (PMID: 26981934) Lancet. 2012 May 12;379(9828):1800-6. (PMID: 22475493) Am J Obstet Gynecol. 2010 Aug;203(2):128.e1-12. (PMID: 20576253) Acta Obstet Gynecol Scand. 2015 Apr;94(4):352-8. (PMID: 25644964) Cochrane Database Syst Rev. 2012 Apr 18;(4):CD008991. (PMID: 22513970) BJOG. 2018 Jan;125(1):8-11. (PMID: 29055092) Lancet. 2013 Oct 19;382(9901):1341-9. (PMID: 23924878) Ultrasound Obstet Gynecol. 2017 Mar;49(3):303-314. (PMID: 28067007) Am J Obstet Gynecol. 1996 Oct;175(4 Pt 1):1047-53. (PMID: 8885774) Am J Obstet Gynecol. 2016 Jan;214(1):3.e1-9. (PMID: 26321037) |
| معلومات مُعتمدة: | U10 HD034208 United States HD NICHD NIH HHS; U24 HD036801 United States HD NICHD NIH HHS; UG1 HD027915 United States HD NICHD NIH HHS; UG1 HD087192 United States HD NICHD NIH HHS; UG1 HD040544 United States HD NICHD NIH HHS; UG1 HD034208 United States HD NICHD NIH HHS; UG1 HD040512 United States HD NICHD NIH HHS |
| تواريخ الأحداث: | Date Created: 20230710 Date Completed: 20240530 Latest Revision: 20240730 |
| رمز التحديث: | 20240730 |
| مُعرف محوري في PubMed: | PMC10776795 |
| DOI: | 10.1055/s-0043-1771018 |
| PMID: | 37429323 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1098-8785 |
|---|---|
| DOI: | 10.1055/s-0043-1771018 |