Randomized, Double-Blind, Multi-center. Phase III Study Comparing the Efficacy and Safety of Retosiban versus Placebo for Women in Spontaneous Labor
Prolonging pregnancy in women with unexpected early labor using study drug Retosiban
Sponsor: GlaxoSmithKline
Enrolling: Female Patients Only
IRB Number: AAAQ5800
U.S. Govt. ID: NCT02377466
Contact: Caroline Torres: 212-305-2158 / ct2179@cumc.columbia.edu
Additional Study Information: The purpose of this study is to test the effect of a drug called retosiban on stopping preterm labor and delaying the birth of her baby. We will also study the safety of the drug to find out what effects; good or bad, retosiban has on women in preterm labor and their fetuses. A previous small study, involving 93 women with preterm labor, found that retosiban increased the time to delivery and had a favourable safety profile. Retosiban is undergoing additional testing but has not yet been approved for the treatment of preterm labor.
This study is closed
Investigator
Cynthia Gyamfi Bannerman, MD
Do You Qualify?
Are you or your child 24 to 33 weeks into pregnancy? Yes No
Has you or your child been diagnosed with preterm labor? Yes No
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For more information, please contact:
Caroline Torres
ct2179@cumc.columbia.edu
212-305-2158
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