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Am J Perinatol
DOI: 10.1055/s-0043-1771018
Original Article

PROMPT: Prospective Meta-analysis for Pessary Trials Study Protocol

Elizabeth A. Thom   †
1   The George Washington University Biostatistics Center, Washington, District of Columbia
,
George R. Saade
2   Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas
,
Lisa M. Askie
3   National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia
,
Lynda G. Ugwu
1   The George Washington University Biostatistics Center, Washington, District of Columbia
,
Ben W.J. Mol 
4   Department of Obstetrics and Gynecology, Monash University, Monash, Australia
,
Christophe Vayssiere
5   Department of Obstetrics and Gynecology, Toulouse III University, Toulouse, France
,
Jane E. Norman
6   University of Nottingham, Nottingham, United Kingdom
,
Eva Pajkrt
7   Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands
,
Rebecca G. Clifton
1   The George Washington University Biostatistics Center, Washington, District of Columbia
,
Joseph R. Biggio
8   Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama
,
Catherine Arnaud
5   Department of Obstetrics and Gynecology, Toulouse III University, Toulouse, France
,
Vincenzo Berghella
9   Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania
,
Maria G. Canino
10   Department of Obstetrics and Gynaecology, Hospital Universitari Vall d'Hebron, Barcelona, Spain
,
Elena Carreras
10   Department of Obstetrics and Gynaecology, Hospital Universitari Vall d'Hebron, Barcelona, Spain
,
Lorraine Dugoff
11   Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania
,
Matthew K. Hoffman 
12   Department of Obstetrics and Gynecology, Columbia University, New York, New York
,
Rodolfo C. Pacagnella
13   Department of Obstetrics and Gynecology, State University of Campinas—UNICAMP, São Paulo, Brazil
,
Uma M. Reddy
14   Division of Extramural Research Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland
,
Gabriele Saccone
15   Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy
,
Janneke van 't Hooft
7   Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands
,
Vinh Q. Dang
16   Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam
,
for the Prospective Meta-analysis for Pessary Trials Collaboration › Author Affiliations Funding Each individual trial has received funding from its own individual funding body. The Eunice Kennedy Shriver NICHD MFMU Network Data Coordinating Center is serving as the data coordinating center for this collaboration.
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Abstract

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.

Keywords

pessary - short cervix - prospective meta-analysis - protocol

Note

Results of the first phase of singleton and twin pessary trials are expected to be available late 2022, with updates planned as participating trials are completed and published.


Ethical Approval

All individual trials are required to have a consent form approved by the local ethics board before trial start-up, and all participants provide consent.


† Deceased




Publication History

Received: 11 December 2022

Accepted: 30 May 2023

Article published online:
10 July 2023

© 2023. Thieme. All rights reserved.

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