Progesterone & Postpartum Relapse to Smoking
Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during
pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery,
women will be randomly assigned to receive 4 weeks of active or placebo exogenous
progesterone starting on the 4th day postpartum. Participants will be in contact with study
staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking
status and protocol compliance, measure serum progesterone levels and receive behavioral
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.
Week 4 Postpartum
Sharon S. Allen, M.D., Ph.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
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