Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix
Authors: Hoffman Matthew K. , Clifton Rebecca G. , Biggio Joseph R. , Saade George R. , Ugwu Lynda G. , Longo Monica , Bousleiman Sabine Z. , Clark Kelly , Grobman William A. , Frey Heather A. , Chauhan Suneet P. , Dugoff Lorraine , Manuck Tracy A. , Chien Edward K. , Rouse Dwight J. , Simhan Hyagriv N. , Esplin M. Sean , Macones George A. ,   National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network, Bickus Melissa T. , Facco Francesca L. , Tita Alan T.N. , Grant Janatha S. , Casey Brian M. , Harris Stacy L. , Harper Lorie M. , Dunn Donna M. , Longo Sherri A. , Hendricks Melissa A. , Lata-Arias Kathleen , Costantine Maged M. , Bartholomew Anna B. C. , Cline Dawn M. , Harper Stephanie L. , Ward Calvin L. , Gardner Nicole M. , Brindle Stephanie J. , Weigand Samantha L. , McKenna David S. , Snow Esther K. , Fennig Kathleen A. , Habli Mounira A. , Lambers Donna S. , McClellan Marta C. , Metz Torri D. , Sowles Amber N. , Varner Michael W. , Hill Kim A. , Morby Valerie S. , Meadows Catherine E. , Allard Donna M. , Werner Erika F. , Rousseau Janet L. , Milano Jane , Pettker Christian M. , Leventhal Jessica , Gyamfi-Bannerman Cynthia , Wapner Ronald J. , Carmona Vilmarie M. , Firman Brandy S. , Vanneman Ashley Q. , Palomares Kristy T. , Beche Imene , Skupski Daniel W. , Chan-Akeley Rosalyn A. , Salazar Ashley E. , Pacheco Luis D. , McCoy Leah M. , Saad Antonio F. , Jain Sangeeta , Omere Chasey I. , Clifford Corey C. , McDonnold Mollie A. , Chien Edward K. , Dalton Wendy B. , Polito LuAnn A. , Milluzi Cynthia J. , Kushner Kathleen M. , Maile Ashley , Bell Jodi N. , Hackney David N. , Ortiz Felecia E. , Timlin Sally A. , Goodnight William H. , Manuck Tracy A. , Beamon Carmen J. , Nun Hannah B. , Eichelberger Kacey Y. , Moore Alison B. , Hughes Brenna L. , Ferrara Jennifer W. , Grobman William A. , Mallett Gail L. , Stein Lara J. , Miller Emily S. , Plunkett Beth A. , Kearns Kathy M. , Palatnik Anna , Malone Tyler , Parry Samuel I. , Pizzi Christina , Craig Jennifer , Filipczak Anna , Thom Elizabeth A. , Doherty Lindsay K. , Hubbard Aubrey K. , Erikson Patricia , Pinto Tara , Marcharchand Pramiksha , Reddy Uma M. , Miodovnik Menachem , Archer Stephanie W. 
Published: July 2023

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