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临床试验/NCT07528664
NCT07528664尚未招募不适用

Randomized, Multicenter, Regional Study in 3 Parallel Arms to Evaluate the Effectiveness of a Prevention Program Based on a Financial Incentive Aimed at the Pregnant Woman and Her Smoking Partner, Designed to Reduce Tobacco Consumption During Pregnancy.

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Tobacco use

研究概览

简要总结

Nearly one in five pregnant women still smoke in the third trimester of pregnancy. This is the highest rate in Europe. Smoking during pregnancy is an established risk factor for the unborn child: risk of ectopic pregnancy, intrauterine growth restriction and prematurity, risk of sudden infant death syndrome (increased two- to threefold), and risk of respiratory problems for the newborn. The risks increase with the frequency and duration of the mother's smoking during pregnancy.

Quitting smoking is essential to prevent the risks associated with tobacco use during pregnancy. The evidence of benefits for the child from pharmacotherapeutic interventions (nicotine replacement therapy) is insufficient. New treatment options must be explored to help pregnant women quit smoking.

Financial incentives are recognized as an effective means of motivating behavior change. It is about impacting the trade-off of quitting smoking. The trade-off consists of the benefits of quitting (improved health and reduced monetary costs because tobacco is no longer purchased) and the costs of quitting (suppressing the satisfaction and pleasure derived from smoking). One consortium member conducted a large clinical trial showing that a financial incentive is an effective intervention to help pregnant women who smoke to quit smoking.

Previous studies have shown that 70% of partners of women who use tobacco are themselves smokers. The partner's smoking is a risk factor for continued tobacco use during pregnancy and can be a source of passive smoking for the mother and child. Women who quit smoking before and after pregnancy are more often in relationships with nonsmoking partners than those who continue to smoke.

The investigator hypothesize that a financial incentive aimed at the partner's abstinence from tobacco will enhance the beneficial effects of the financial incentive on reducing or stopping tobacco use during pregnancy. The investigator also hypothesize that incentivizing the partner to stop smoking will help strengthen their engagement in family life.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Consent to participate in the study
  • Agree to monthly prenatal follow-up at the maternity unit
  • Understand French
  • Are enrolled in health insurance or benefit from AME (Aide Médicale d'État)
  • 18 years of age or older

排除标准

  • Who do not wish to quit smoking
  • Whose partner does not wish to quit smoking
  • Who use electronic cigarettes in a complementary or exclusive manner (not applied to the partner) at inclusion
  • Who will separate from the father of the unborn child and/or no longer cohabit with him
  • Who will not be able to participate in the entirety of the study (e.g., planning to move after the birth of the child)
  • Who do not wish to give birth in one of the study maternities.

研究组 & 干预措施

"pregnant woman and partner"

Experimental

Experimental arm "pregnant woman and partner": A medical consultation will be scheduled every 4 weeks from the inclusion visit (between the 12th and 16th week of pregnancy) and until delivery. This visit will assess cigarette consumption during the previous 4 weeks. This assessment will be based on questions/answers (self-reported) and the measurement of exhaled CO. It will determine whether the pregnant woman and her partner (pregnant woman and partner arm) may be awarded a financial incentive.

干预措施: Financial incentive contingent on tobacco abstinence. (Behavioral)

"pregnant woman"

Experimental

Experimental arm "pregnant woman": A medical consultation will be scheduled every 4 weeks from the inclusion visit (between the 12th and 16th week of pregnancy) and until delivery. This visit will assess cigarette consumption during the previous 4 weeks. This assessment will be based on questions/answers (self-reported) and the measurement of exhaled CO. It will determine whether the pregnant woman (pregnant woman arm) may be awarded a financial incentive.

干预措施: Financial incentive contingent on tobacco abstinence. (Behavioral)

Control arm

Active Comparator

In the control group, parental care will follow the current practices in maternity care and the guidelines of Santé publique France in effect at the start of the study.

干预措施: Standar care (Radiation)

结局指标

主要结局

Tobacco use

时间窗: Birth of the child

Number of months the pregnant woman has abstained from smoking from enrollment (12th to 16th week) until birth.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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