152
Participants
Start Date
October 31, 2011
Primary Completion Date
April 30, 2014
Study Completion Date
October 31, 2014
17-alpha-hydroxy-progesterone caproate, Makena®
Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
Castor Oil (Placebo)
IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
University of South Alabama Medical Center, Mobile
Norton Kosair Children's Hospital, Louisville
Spectrum Health Hospital, Grand Rapids
Saint Luke's Hospital, Kansas City, Kansas City
Swedish Medical Center, Denver
Presbyterian/St Luke's Hospital, Denver
Banner Good Samaritan Hospital, Phoenix
Desert Good Samaritan Hospital, Mesa
Tucson Medical Center, Tucson
Sunrise Medical Center, Las Vegas
Good Samaritan Hospital, San Jose
OConnor Hospital, San Jose
Long Beach Memorial Medical Center, Long Beach
University of Cincinnati, Cincinnati
Swedish Medical Center, Seattle
Lead Sponsor
Obstetrix Medical Group
INDUSTRY