Progesterone & Postpartum Relapse to Smoking
The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Progesterone & Postpartum Relapse to Smoking|
- Relapse Rate [ Time Frame: Week 4 Postpartum ] [ Designated as safety issue: No ]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.
- Relapse Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Days to Relapse [ Time Frame: Day 0 to 84 ] [ Designated as safety issue: No ]Defined by continuous abstinence (CA) and prolonged abstinence (PA). CA defined as a single puff of a cigarette as a relapse. PA measure reflects sustained abstinence and defines relapse as seven consecutive slip (e.g., a puff or more) without a 24 hours period between any slip.
- Protocol Compliance [ Time Frame: Gestational Week 35 and Weeks 2, 6, and 12 Postpartum ] [ Designated as safety issue: No ]Defined as the complete requirements (e.g.,number of visits attended, doses of medication taken, electronic data capture completed) divided by number possible multiplied by 100%.
- Compliance Determinants [ Time Frame: Gestational Week 36 and Weeks 2, 6 and 12 Postpartum ] [ Designated as safety issue: No ]This is a questionnaire assessing participant expectations, satisfaction and study protocol, study medication and electronic data capture. It contains 10 scaled items adapted from a published instrument; all questions are answered with a four-point Likert-type scale. The score of the feasibility questionnaire will be determined by computing a sum, yielding an acceptability score.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1 - Progesterone Group
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Placebo Comparator: Arm 2 - Placebo
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
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 counseling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798394
|Contact: Nicole L Tosun, M.S.||firstname.lastname@example.org|
|United States, Minnesota|
|University of Minnesota, 717 Delaware Street SE||Recruiting|
|Minneapolis, Minnesota, United States, 55414|
|Contact: Nicole L. Tosun, M.S. 612-624-5350 email@example.com|
|Principal Investigator: Sharon S. Allen, M.D., Ph.D.|
|Principal Investigator:||Sharon S. Allen, M.D., Ph.D.||Masonic Cancer Center, University of Minnesota|