Progesterone & Postpartum Relapse to Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of Participants Who Relapsed by Week 4 Postpartum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-35 years old
- •Zero CPD for past 4 weeks
- •5 or more CPD for at least 6 out of past 12 months
- •Motivated to remain abstinent (7 or higher out of 10)
- •Stable physical/mental health
- •Established prenatal care
- •Stable physical/mental health
- •Willing to take Progesterone
- •Willing to use double-barrier protection if sexually active
- •English fluency
- •Able to provide informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Progesterone (Drug)
Placebo
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Who Relapsed by Week 4 Postpartum
时间窗: 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.
次要结局
- Compliance Determinants(Postpartum Week 12)
- Number of Participants Who Relapsed by Week 12 Postpartum(Week 12 Postpartum)
- Number of Participants Who Relapsed at All During Postpartum (up to Day 84)(Postpartum Day 0 to 84)
- Protocol Compliance - Number of Visits Attended(Gestational Week 36 - Postpartum Week 12)
- Protocol Compliance - Doses of Medication Taken(Postpartum Week 0 - Week 12)
- Protocol Compliance - EDC's Completed(Gestational Week 36 - Postpartum Week 12)