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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
46
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
University of Minnesota, 717 Delaware Street SE
Minneapolis, Minnesota, United States
Number of Participants Who Relapsed by Week 4 Postpartum
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.
Time frame: Week 4 Postpartum
Number of Participants Who Relapsed by Week 12 Postpartum
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.
Time frame: Week 12 Postpartum
Number of Participants Who Relapsed at All During Postpartum (up to Day 84)
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
Time frame: Postpartum Day 0 to 84
Protocol Compliance - Number of Visits Attended
Compliance was measured as the number of visits attended (maximum of 5).
Time frame: Gestational Week 36 - Postpartum Week 12
Compliance Determinants
This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.
Time frame: Postpartum Week 12
Protocol Compliance - Doses of Medication Taken
Compliance was measured by doses of medication taken (maximum of 56).
Time frame: Postpartum Week 0 - Week 12
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Protocol Compliance - EDC's Completed
Compliance was measured as the number by number of EDCs completed (maximum of 84).
Time frame: Gestational Week 36 - Postpartum Week 12