| CTRI Number |
CTRI/2021/09/036944 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Antenatal Tobacco Cessation Support Program among pregnant women availing ANC care at Pravara Rural Hospital, Loni |
|
Scientific Title of Study
|
Effectiveness of Antenatal Tobacco Cessation Support Program among pregnant women availing ANC care at Pravara Rural Hospital, Loni: A feasibility study |
| Trial Acronym |
ANTCP trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AKANSHA SEHGAL |
| Designation |
Student, Rural Medical College, Pravara Institute of Medical Sciences |
| Affiliation |
Rural Medical College, Pravara Institute of Medical Sciences |
| Address |
Room 313, Ladies hostel, Pravara Institute of medical sciences, District Ahmednagar, Taluka Rahata, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8375831035 |
| Fax |
|
| Email |
akansha2398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MC Tayade |
| Designation |
Professor of Physiology, Pravara Institute of Medical Sciences |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Staff quarters, Pravara Institute of medical sciences, District Ahmednagar, Taluka Rahata, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9604102508 |
| Fax |
|
| Email |
drmctayade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akansha Sehgal |
| Designation |
Student, Rural Medical College, Pravara Institute of Medical Sciences |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Room 313, Ladies Hostel, Pravara Institute of medical sciences, District Ahmednagar, Taluka Rahata, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
|
| Fax |
|
| Email |
akansha2398@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Health Research and Education, UK |
| Pravara Institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Rural Medical College |
| Address |
Pravara Institute of medical sciences, District Ahmednagar, Taluka Rahata, Loni, 413736 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Centre for Health Research and Education |
2 Venture Road,
University of Southampton Science Park,
Chilworth, Hampshire, SO16 7NP |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akansha Sehgal |
Pravara Rural Hospital |
Department of Obstetrics and Gynaecology, Taluka Rahata, District Ahmednagar, Loni
Ahmadnagar
MAHARASHTRA |
8375831035
akansha2398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee PIMS DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health Education |
Those not willing to quit, will be subjected to Health Education and given pamphlets with information regarding cessation |
| Intervention |
Very Brief counselling, Brief Advice and Nicotine Replacement Therapy if required |
The participants will be identified by screening during ANC visit by the OBGY Department and women consuming tobacco will be subjected to detailed history taking and Very Brief Counselling. Thereafter, the candidates willing to quit will be referred to the Tobacco Research and Cessation Centre, Loni for Brief Advice with the help of Five A’s Framework and offered Nicotine Replacement Therapy (NRT) for duration ascertained by the treating doctor, as required by each patient. Those not willing to quit, will be subjected to Health Education and given pamphlets with information regarding cessation. They will also be provided with adequate follow up contact details. Follow up will be done to assess any behavioural change regarding tobacco consumption. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women aged above 18 years
2.Women attending ANC clinic at PRH, Loni
3.Women consuming any tobacco products
4.Those who give written informed consent for participating in the study
|
|
| ExclusionCriteria |
| Details |
1.Women less than 18 years of age
2.Pregnant women not regularly taking follow up at ANC
3.Women not consuming tobacco during pregnancy
4.Women not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Abstinence during pregnancy as ascertained by urine cotinine test. |
at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Referral rates to TRCC from OBGY Department.
2. Uptake rates at TRCC for intervention.
3. Barriers to cessation ascertained by Focus Group Discussions with patients and providers.
4. Fidelity with intervention as assessed by independent observer.
5. Client satisfaction.
6. Adverse effects.
7. Pregnancy outcomes.
8. Follow up completion
|
at 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Consuming tobacco during pregnancy may lead to adverse perinatal outcomes and harm to the health of the baby. The project aims to study the effectiveness of screening women for tobacco consumption during ANC visit, to recruit women who consume tobacco products for Antenatal Tobacco Cessation Support Program and identify barriers therein and study the effectiveness of brief counselling for tobacco cessation support among ANC mothers. And find the proportion of women who abstain from tobacco use at the end of the study. The participants will be identified by screening during ANC visit by the OBGY Department and women consuming tobacco will be subjected to detailed history taking and Very Brief Counselling. Thereafter, the candidates willing to quit will be referred to the TRCC Clinic for Brief Advice with the help of Five A’s Framework and offered Nicotine Replacement Therapy (NRT) as required. Those not willing to quit, will be subjected to Health Education and given pamphlets with information regarding cessation. They will also be provided with adequate follow up contact details. Follow up will be done to assess any behavioural change regarding tobacco consumption and urine cotinine test will be used to confirm abstinence. |