University of Minnesota, 717 Delaware Street SE
Minneapolis, Minnesota, 55414, United States
NCT Number: NCT01798394
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.
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Minneapolis, Minnesota, 55414, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Other names: Prometrium
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Time frame: 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 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: Postpartum Day 0 to 84
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
Time frame: Gestational Week 36 - Postpartum Week 12
Compliance was measured as the number of visits attended (maximum of 5).
Time frame: Postpartum Week 12
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 0 - Week 12
Compliance was measured by doses of medication taken (maximum of 56).
Time frame: Gestational Week 36 - Postpartum Week 12
Compliance was measured as the number by number of EDCs completed (maximum of 84).
University of Minnesota
Other
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