Progesterone & Postpartum Relapse to Smoking

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Psychotropic medications
Illicit drugs
Other types of tobacco, NRT, smoking cessation medications
Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of >2 miscarriages)
Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Progesterone	Progesterone	Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Relapsed by Week 4 Postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Relapsed by Week 12 Postpartum	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.
Number of Participants Who Relapsed at All During Postpartum (up to Day 84)	Postpartum Day 0 to 84	Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
Protocol Compliance - Number of Visits Attended	Gestational Week 36 - Postpartum Week 12	Compliance was measured as the number of visits attended (maximum of 5).
Compliance Determinants	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.
Protocol Compliance - Doses of Medication Taken	Postpartum Week 0 - Week 12	Compliance was measured by doses of medication taken (maximum of 56).
Protocol Compliance - EDC's Completed	Gestational Week 36 - Postpartum Week 12	Compliance was measured as the number by number of EDCs completed (maximum of 84).