Development & Pilot Testing of a Novel Multi-component Intervention Using Biomarker Feedback and Cognitive-Social Health Information-Processing (C-SHIP) Model Based Intervention for Smokeless Tobacco Cessation during Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Estimate recruitment and retention rates.
研究概览
简要总结
Studies have reported that tobacco use during pregnancy has been associated with pregnancy complications (ie, placenta praevia, placental abruption, and pre-eclampsia) and poor fetal outcomes (ie, low birthweight, premature birth, and overall perinatal mortality). Global Adult Tobacco Survey (GATS) India reported that the prevalence of overall tobacco use among females is 14.2 percent. Prevalence of smoking among females is 2 percent whereas the prevalence of smokeless tobacco products (Gutkha, Khaini, Paan Masala,Gul, Mawa, Misri, etc.) among females is 12.8% .Various studies report that no differences have been noted between pregnant and non-pregnant women in smokeless tobacco prevalence and use patterns.
Healthcare professionals routinely ask a pregnant woman about tobacco use during antenatal visits and provide counselling to pregnant women to give up tobacco at least during pregnancy and possibly forever. Unfortunately, most of the pregnant women continue to use smokeless tobacco after getting registration at Antenatal Clinic (ANC). It reflects that only counselling is not effective intervention for smokeless to tobacco cessation in pregnancy. Also, several forms of smokeless tobacco are sometimes considered by pregnant women as a form of medicine to treat common ailments. Use of smokeless tobacco by women is well accepted in Indian society, and use of Mishri (tobacco containing teeth cleaning powder) is very common. Most of the pregnant women are not aware about any harmful effects of smokeless tobacco. There is a dearth of studies on effective interventions for smokeless tobacco use in pregnancy in most of low- and middle- income countries. There are currently no up-to-date, evidence based guidelines for identifying and managing smokeless tobacco use in pregnancy in India. There have been no trials to study effect of multicomponent intervention in pregnant women using smokeless tobacco. A 2011 Cochrane review of interventions for smokeless tobacco cessation identified 12 trials involving behavioural interventions in the adults, but these trials did not involve pregnant women. Pregnancy is a ‘teachable moment’ for women. Such a study has still not been conducted in the Indian population. Hence there is a great need to design effective smokeless tobacco cessation interventions for healthcare professionals to help pregnant women in quitting smokeless tobacco as cessation of tobacco during the pregnancy is very important for primary prevention of low birth weight and other adverse perinatal health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •for pregnant females Women with 12 weeks or less than 12 weeks pregnancy Smokeless tobacco uses within last 2 days Visiting in the antenatal clinic Aged 18 or above Communicate in Hindi or English Inclusion criteria for non pregnant females Smokeless tobacco uses within last 2 days Aged 18 or above Communicate in Hindi or English Age, education, and socio-economic status matched with pregnant females.
排除标准
- •for pregnant females Those with unstable medical conditions as advised by the doctor in charge Poor cognitive state Having mental illness Those participating in other tobacco cessation program Exclusion criteria for non pregnant females Those with unstable medical conditions as advised by the doctor in charge Poor cognitive state Having mental illness Those participating in other tobacco cessation program.
结局指标
主要结局
Estimate recruitment and retention rates.
时间窗: 32 weeks Pregnancy
30 days Point prevalence abstinence in late pregnancy (32 weeks) (self-reported tobacco use status will be obtained and will be biochemically verified through use urine cotinine testing)
时间窗: 32 weeks Pregnancy
次要结局
- Continued abstinence in late pregnancy (32 weeks) after quitting in early pregnancy (self-reported tobacco use status will be obtained & will be biochemically verified through use of urine cotinine testing).(Smokeless tobacco reduction from the first antenatal visit to late pregnancy (32weeks): Any reducing quantity of smokeless tobacco (self-Reported))
研究者
Dr Parbhoo Dayal
All India Institute of Medical Sciences, New Delhi
