NCT02518594

A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,311 (actual)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Detailed description

This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. Multiple gestation increases the risk of preterm delivery. Babies born preterm have increased rates of neonatal mortality and long-term neurodevelopmental morbidities. Short cervical length is known to be an important risk factor for spontaneous preterm birth and to occur more frequently in women with a twin gestation. Although there is no evidence that progesterone reduces the risk of preterm birth in multifetal gestation, there is evidence that progesterone reduces the risk of prematurity in singleton gestations complicated with a short cervix. The Arabin pessary has also been shown to reduce the risk of preterm birth among singletons with a short cervix, and in a secondary subgroup analysis of a recent study of the use of pessary in multiple gestations, women with a cervical length \< 25th percentile had a significantly reduced risk of the primary composite neonatal adverse outcome. Secondary analysis of studies of vaginal progesterone in multiple gestation with a short cervix also suggest a possible beneficial effect on preterm delivery.

Conditions

• Short Cervical Length

Interventions

Type	Name	Description
DRUG	Vaginal progesterone	200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks
DRUG	Placebo	placebo softgel capsule, daily from randomization to \< 35 wks
DEVICE	Arabin Pessary	placement and management of an Arabin Pessary from randomization to \< 35 wks

Timeline

• Start date: 2015-11-13
• Primary completion: 2024-12-15
• Completion: 2025-02-18
• First posted: 2015-08-10
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study