A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix — TOPS  

Preterm Delivery Clinical Trial

Official title: A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix

Status Terminated

Clinical Trial Summary

The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.

Clinical Trial Description

While cervical length is one of the most powerful predictors of subsequent preterm birth, the best treatment to reduce subsequent preterm birth remains unknown. This study is a randomized trial of women who have a singleton pregnancy and a short cervical length on transvaginal ultrasound as determined by a study-certified sonographer. It is being conducted at 12 clinical centers across the country and the recruitment target is enrollment of 850 pregnant women. Participants will be randomized to 1) Arabin pessary or 2) usual care as per by local hospital protocol. Pessary is a promising low-cost, non-surgical intervention that appears to be well-tolerated. The pessary will be placed by obstetric providers trained in appropriate placement of the Arabin pessary. The primary outcome of the study is delivery or fetal death prior to 37 weeks 0 days gestational age.

In the literature, there are two large trials that have produced conflicting results (M Goya et al, 2012, K Nicolaides et al, 2016). Thus, the results of an adequately powered and appropriately conducted trial from the United States will be important in determining whether pessary is a useful intervention for the prevention of subsequent preterm birth in women with singleton gestation. ;

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery
• Short Cervix

• NCT number: NCT02901626
• Study type: Interventional
• Source: The George Washington University Biostatistics Center
• Status: Terminated
• Phase: Phase 3
• Start date: February 14, 2017
• Completion date: May 10, 2022