Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix
Author:
Hoffman Matthew K.1, Clifton Rebecca G.2, Biggio Joseph R.3, Saade George R.4, Ugwu Lynda G.2, Longo Monica5, Bousleiman Sabine Z.1, Clark Kelly6, Grobman William A.7, Frey Heather A.8, Chauhan Suneet P.9, Dugoff Lorraine10, Manuck Tracy A.6, Chien Edward K.11, Rouse Dwight J.12, Simhan Hyagriv N.13, Esplin M. Sean14, Macones George A.15, Bickus Melissa T.16, Facco Francesca L.16, Tita Alan T.N.16, Grant Janatha S.16, Casey Brian M.16, Harris Stacy L.16, Harper Lorie M.16, Dunn Donna M.16, Longo Sherri A.16, Hendricks Melissa A.16, Lata-Arias Kathleen16, Costantine Maged M.16, Bartholomew Anna B. C.16, Cline Dawn M.16, Harper Stephanie L.16, Ward Calvin L.16, Gardner Nicole M.16, Brindle Stephanie J.16, Weigand Samantha L.16, McKenna David S.16, Snow Esther K.16, Fennig Kathleen A.16, Habli Mounira A.16, Lambers Donna S.16, McClellan Marta C.16, Metz Torri D.16, Sowles Amber N.16, Varner Michael W.16, Hill Kim A.16, Morby Valerie S.16, Meadows Catherine E.16, Allard Donna M.16, Werner Erika F.16, Rousseau Janet L.16, Milano Jane16, Pettker Christian M.16, Leventhal Jessica16, Gyamfi-Bannerman Cynthia16, Wapner Ronald J.16, Carmona Vilmarie M.16, Firman Brandy S.16, Vanneman Ashley Q.16, Palomares Kristy T.16, Beche Imene16, Skupski Daniel W.16, Chan-Akeley Rosalyn A.16, Salazar Ashley E.16, Pacheco Luis D.16, McCoy Leah M.16, Saad Antonio F.16, Jain Sangeeta16, Omere Chasey I.16, Clifford Corey C.16, McDonnold Mollie A.16, Chien Edward K.16, Dalton Wendy B.16, Polito LuAnn A.16, Milluzi Cynthia J.16, Kushner Kathleen M.16, Maile Ashley16, Bell Jodi N.16, Hackney David N.16, Ortiz Felecia E.16, Timlin Sally A.16, Goodnight William H.16, Manuck Tracy A.16, Beamon Carmen J.16, Nun Hannah B.16, Eichelberger Kacey Y.16, Moore Alison B.16, Hughes Brenna L.16, Ferrara Jennifer W.16, Grobman William A.16, Mallett Gail L.16, Stein Lara J.16, Miller Emily S.16, Plunkett Beth A.16, Kearns Kathy M.16, Palatnik Anna16, Malone Tyler16, Parry Samuel I.16, Pizzi Christina16, Craig Jennifer16, Filipczak Anna16, Thom Elizabeth A.16, Doherty Lindsay K.16, Hubbard Aubrey K.16, Erikson Patricia16, Pinto Tara16, Marcharchand Pramiksha16, Reddy Uma M.16, Miodovnik Menachem16, Archer Stephanie W.16,
Affiliation:
1. Department of Obstetrics and Gynecology, Columbia University, New York, New York 2. George Washington University Biostatistics Center, Washington, DC 3. University of Alabama at Birmingham, Birmingham 4. University of Texas Medical Branch at Galveston, Galveston 5. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland 6. University of North Carolina at Chapel Hill, Chapel Hill 7. Northwestern University, Chicago, Illinois 8. The Ohio State University, Columbus 9. University of Texas Health Science at Houston–Children’s Memorial Hermann Hospital, Houston 10. Hospital of the University of Pennsylvania, Philadelphia 11. MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio 12. Brown University, Providence, Rhode Island 13. The University of Pittsburgh, Pittsburgh, Pennsylvania 14. University of Utah Health Sciences Center, Salt Lake City 15. University of Texas at Austin, Austin 16. for the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network
Abstract
ImportanceA 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.ObjectiveTo 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 ParticipantsWe 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.InterventionsParticipants 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 MeasuresThe primary outcome was delivery or fetal death prior to 37 weeks.ResultsA 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 RelevanceCervical 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 RegistrationClinicalTrials.gov Identifier: NCT02901626
Publisher
American Medical Association (AMA)
Cited by
16 articles.
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