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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.
Insights
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.
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.
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..
