CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,311 enrolled / 1,311 target
Drug / intervention
Vaginal progesterone +2 moredrug
Likely dose
Vaginal progesterone 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02518594
NCT02518594Phase 3CompletedOn Track (10.3/mo)Completion was 18mo ago
CompareCT.gov

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

The George Washington University Biostatistics Center·interventional·Posted Aug 10, 2015·Updated Jun 25, 2026

In Brief

A Phase 3 clinical trial evaluating Vaginal progesterone, Placebo, and 1 other intervention for Short Cervical Length. Completed, enrolled 1,311 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Cervical Length
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 10, 2015
Enrollment StartNov 13, 2015
Primary CompletionDec 15, 2024
Study CompletionFeb 18, 2025
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 10.9 years ago

Arms & Interventions

Progesteroneactive_comparator

vaginal progesterone capsule

Drug: Vaginal progesterone
Placeboplacebo_comparator

placebo capsule

Drug: Placebo
Arabin Pessaryactive_comparator

Arabin Pessary

Device: Arabin Pessary

Interventions

Vaginal progesteronedrug

200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks

Placebodrug

placebo softgel capsule, daily from randomization to \< 35 wks

Arabin Pessarydevice

placement and management of an Arabin Pessary from randomization to \< 35 wks