1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [prabhudayal.aiims@gmail.com].
   


6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-04-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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.