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

NCT02518594 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1311

Last updated 2026-03-10

Study results available
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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.

Conditions

  • Short Cervical Length

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Joseph Biggio, MD · Maternal Fetal Medicine Units (MFMU) Network

  • Monica Longo, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-13
Primary Completion
2024-12-15
Completion
2025-02-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02518594 on ClinicalTrials.gov