437
Participants
Start Date
November 13, 2015
Primary Completion Date
December 15, 2024
Study Completion Date
February 18, 2025
Vaginal progesterone
200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks
Placebo
placebo softgel capsule, daily from randomization to \< 35 wks
Arabin Pessary
Placement management from randomization to \< 35 wks
Columbia University, New York
Magee Women's Hospital, Pittsburgh
Hospital of the University of Pennsylvania, Philadelphia
University of North Carolina - Chapel Hill, Chapel Hill
Duke University, Durham
University of Alabama - Birmingham, Birmingham
Ohio State University, Columbus
Case Western Reserve University, Cleveland
Northwestern University-Prentice Hospital, Chicago
University of Texas - Houston, Houston
University of Texas - Galveston, Galveston
University of Colorado, Denver
University of Utah Medical Center, Salt Lake City
The Regents of the University of California, San Francisco, San Francisco
Baylor College of Medicine, Houston
Brown University, Providence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER