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PROMPT: Prospective Meta-analysis for Pessary Trials Study Protocol.

Elizabeth A Thom¹, George R Saade², Lisa M Askie³

¹The George Washington University Biostatistics Center, Washington, District of Columbia.

American Journal of Perinatology

|July 10, 2023

Summary

A short cervix is a strong predictor of preterm birth. An international collaboration formed the PROspective Meta-analysis of Pessary Trials (PROMPT) to analyze data from randomized trials of cervical pessary use to prevent preterm birth.

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Area of Science:

Maternal-fetal medicine
Perinatology
Obstetrics

Background:

Preterm birth (<37 weeks gestation) is a major cause of infant mortality and long-term disability.
A short cervix in the second trimester is a significant predictor of spontaneous preterm birth.
Previous studies on the effectiveness of Arabin pessary for preventing preterm birth in singleton gestations with short cervix have yielded conflicting results.

Purpose of the Study:

To establish an international collaborative of randomized trials investigating the use of pessary for singleton and twin gestations with a short cervix.
To conduct a prospective individual patient data (IPD) meta-analysis of these trials.

Main Methods:

Formation of the PROspective Meta-analysis of Pessary Trials (PROMPT) collaboration in November 2014.
Agreement on IPD meta-analysis hypotheses, eligibility criteria, and core outcome measures for singleton and twin gestations.
Primary outcome: composite of fetal death or preterm delivery before 32 weeks' gestation; secondary outcomes include maternal and neonatal morbidities.

Main Results:

Results are to be published in phases as individual studies conclude.
The first phase of results from singleton and twin pessary trials is anticipated in late 2022.
Updates will be provided as participating trials are completed and published.

Conclusions:

A meta-analysis of pessary trials is underway to clarify its efficacy in preventing preterm birth.
Short cervical length is a validated predictor of preterm birth.
Further results from the PROMPT collaboration will inform clinical practice regarding cervical support.