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CTRI Number  CTRI/2020/07/026458 [Registered on: 09/07/2020] Trial Registered Prospectively
Last Modified On: 06/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [nursing]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to assess effectiveness of nurse led information package on oral health of aantenatal mothers. 
Scientific Title of Study   A Quasi-experimental study to assess the effectiveness of a“Nurse led information package on Oral health”to maintain oral hygiene among antenatal mothers attending Obstetrics and Gynaecology, OPD, PGIMER, Chandigarh, 2019-21 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parul Negi 
Designation  Msc nursing student 
Affiliation  National institute of nursing education, Post graduate institute of medical education and research 
Address  Room no 208,second floor,National Institute of nursing education , Post Graduate Institute of Medical Education and research,sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  7973459636  
Fax    
Email  negiparul91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhjit Kaur 
Designation  Tutor 
Affiliation  National institute of nursing education, Post graduate institute of medical education and research 
Address  Room no 134,first floor National institute of nursing education, Post graduate institute of medical education and research,sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9914536469  
Fax    
Email  drsukhjitkaur13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parul Negi 
Designation  Msc Nursing student 
Affiliation  National institute of nursing education, Post graduate institute of medical education and research 
Address  Room no 208, second floor,National institute of nursing education, Postgraduate Institute of Medical education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  7973459636  
Fax    
Email  negiparul91@gmail.com  
 
Source of Monetary or Material Support  
National institute of nursing education,post graduate institute of medical education and research,sector 12, chandigarh 
 
Primary Sponsor  
Name  National institute of nursing education 
Address  national institute of nursing education, Post graduate institute of medical education and research,sector 12, chandigarh, 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Post graduate institute of medical education and research  Post graduate institute of medical education and research, sector 12, chandigarh, pin 160012 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Parul Negi  Post graduate institute of medical education and research  Antenatal clinic, New OPD,second floor,Post graduate institute of medical education and researc,sector 12
Chandigarh
CHANDIGARH 		 7973459636

negiparul91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O989||Unspecified maternal infectious and parasitic disease complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse led information package on oral health  Nurse led information package for oral health – It refers to the booklet containing information about anatomy of oral mucosa and teeth, changes in oral mucosa during pregnancy, importance of oral hygiene in pregnancy, how to maintain dental hygiene in antenatal and postnatal period for antenatal mothers attending Obstetrics and Gynaecology OPD, PGIMER, Chandigarh. 
Comparator Agent  Routine antenatal care  Routine antenatal care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Antenatal mothers attending Obstetrics and Gynaecology, OPD, PGIMER, Chandigarh. 
 
ExclusionCriteria 
Details  Antenatal mothers attending dental OPD, PGIMER, Chandigarh 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To maintain oral hygiene  First trimester woman after one month and second trimester after 15 days, third trimester after one week 
 
Secondary Outcome  
Outcome  TimePoints 
To maintain oral hygiene  First trimester after one month, second trimester after 15 days and third trimester after one week 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 3 
Date of First Enrollment (India)   16/07/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary    During clinical experience researcher observed that antenatal mother visiting antenatal clinic have inadequate knowledge regarding importance of oral health  and those having knowledge might not be able to practice due to various myths regarding dental health. Hence attempt has been taken to assess the effectiveness of “Nurse led information package on oral health”  to maintain oral hygiene among antenatal mothers attending Obstetrics and Gynaecology OPD, PGIMER.
Objectives of the study are-
To develop and implement “Nurse led information package on Oral health” among antenatal mothers attending Obstetrics and Gynaecology OPD, PGIMER, Chandigarh.
To assess the effectiveness of “Nurse led information package on Oral health” on oral hygiene  among antenatal mothers attending Obstetrics and Gynaecology OPD, PGIMER, Chandigarh.

 
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