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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

调整黄体酮和雌二醇水平以防止产后吸烟复吸并减少婴儿和儿童的二手烟暴露

基本信息

批准号：
10430230
负责人：
SHARON S ALLEN
金额：
$ 62.12万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2026-06-30
项目状态：
未结题

项目摘要

Project Summary/Abstract Postpartum smoking relapse rates have remained stagnant for over a decade with more than 50% of those who are able to achieve smoking abstinence during pregnancy relapsing within the first few months after childbirth. Maternal cigarette smoking results in significant increases in a variety of negative health consequences for both mother and child. Second-hand smoke exposure to newborns and infants increases their risk of both acute and chronic illness. Therefore, research to identify safe and novel postpartum smoking relapse prevention intervention is warranted. Our preliminary data indicates that the delivery of exogenous progesterone (Prog) in the early postpartum period reduces several smoking relapse related risk factors (e.g., craving) and was also associated with a higher prevalence of smoking abstinence at 12-weeks postpartum. These observations concur with a wealth of prior literature that demonstrates the protective effects of progesterone on a variety of addictive behaviors. In our other preliminary work looking at non-pregnant premenopausal women, depot medroxyprogesterone acetate or DMPA, which blocks ovulation for 12-weeks which subsequently decreases estradiol levels, was associated with longer previous quit attempts and reduced smoking motives. These observations have shaped our central hypothesis which is that the combination of Prog + DMPA; i.e., increased progesterone and decreased estradiol will prevent postpartum smoking relapse. To examine this hypothesis, we will conduct a double-blind, placebo-controlled, randomized clinical trial that will be implemented by an experienced, transdisciplinary, and productive team of investigators from two sites to enhance the diversity of the study sample and generalizability of the results. We will enroll healthy pregnant women (n=320) who have recently quit smoking and intend to stay abstinent postpartum. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog + DMPA, (2) Prog + placebo, (3) placebo + DMPA, and (4) placebo + placebo. Participants will be followed for days to smoking relapse (primary outcome), smoking relapse-related risk factors (e.g., craving), and infant health outcomes from gestational week 36 through 9 months postpartum. This study proposes a safe and innovative intervention to examine the impact of manipulating postpartum physiological to influence the behavior of a new mother which will lead to improved health outcomes for her and her infant. The implications of this novel study will directly advance the current state of the science by expanding on the role of Prog and DMPA in addressing smoking-related behaviors within this highly vulnerable population. Further, should our central hypothesis be supported, the clinical translatability of this intervention is high and may be immediately pursued.

项目总结/摘要产后吸烟复吸率十多年来一直停滞不前，其中超过50%的人在怀孕期间能够戒烟的妇女在怀孕后的头几个月内复发分娩母亲吸烟导致各种负面健康显着增加对母亲和孩子都有影响。新生儿和婴儿接触二手烟增加急性和慢性疾病的风险。因此，研究确定安全和新颖的产后吸烟需要采取预防复发的干预措施。我们的初步数据表明，孕激素（Prog）在产后早期降低了几种吸烟复发相关的风险因素（例如，渴望），并与产后12周戒烟率较高有关。这些观察结果与大量先前文献一致，这些文献证明了孕酮对各种成瘾行为的影响。在我们的另一项初步工作中，绝经前妇女，长效醋酸甲羟孕酮或DMPA，阻断排卵12周随后降低雌二醇水平，与先前较长的戒烟尝试相关，吸烟动机这些观察形成了我们的中心假设，即 Prog + DMPA;即，增加孕酮和减少雌二醇将防止产后吸烟复发。为了验证这一假设，我们将进行一项双盲、安慰剂对照、随机临床试验，将由来自两个研究中心的经验丰富、跨学科和富有成效的研究者团队实施以增加研究样本的多样性和结果的普遍性。我们将招募健康的孕妇最近戒烟并打算在产后保持禁欲的女性（n=320）。使用2×2阶乘设计，参与者将被随机分配到四个分配之一：（1）Prog + DMPA，（2）Prog +安慰剂，（3）安慰剂+ DMPA，和（4）安慰剂+安慰剂。将对参与者进行为期数天的随访，直至吸烟复发（主要结果），吸烟复发相关的风险因素（例如，渴望），以及妊娠期产后36周到9个月。这项研究提出了一种安全和创新的干预措施，以检查操纵产后生理的影响，以影响新妈妈的行为，这将导致改善了她和她婴儿的健康状况。这项新研究的意义将直接推动通过扩大Prog和DMPA在解决吸烟相关问题中的作用，这一高度弱势群体的行为。此外，如果我们的中心假设得到支持，这种干预的临床可转化性很高，可以立即进行。