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CTRI Number  CTRI/2022/10/046743 [Registered on: 25/10/2022] Trial Registered Prospectively
Last Modified On: 21/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [TEENAGE PARENTHOOD PACKAGE- EDUCATION]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Teenage Parenthood Package on maternal & fetal outcome and experience of pregnancy among Teenage mothers 
Scientific Title of Study   "EFFECTIVENESS OF TEENAGE PARENTHOOD PACKAGE ON MATERNAL & FETAL OUTCOME AND EXPERIENCE OF PREGNANCY AMONG TEENAGE MOTHERS AT SELECTED SETTING, CHENNAI - MIXED METHOD APPROACH" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ELIZEBETH RANI V 
Designation  Professor, PhD Scholar, obstetrical & Gynaecology Nursing Department 
Affiliation  The Tamilnadu DR MGR Medical University, chennai.  
Address  Omayal Achi College of Nursing 45, Ambattur Road, Puzhal Chennai-600 066
No4A, 1st Main road, Prabu Nagar, Pallikaranai, Chennai- 100.
Chennai
TAMIL NADU
600 066
India 
Phone  9965424031  
Fax  26591616  
Email  elsam82@ymail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jolly Ranjith  
Designation  Professor and Head of the Department MEDICAL SURGICAL NURSING 
Affiliation  The Tamilnadu DR MGR Medical University, chennai.  
Address  Omayal Achi College of Nursing 45, Ambattur Road, Puzhal Chennai-600 066
Flat A1, RC Princess Royal Apt, No.62, 64, Siruvallur Road, Perambur, Chennai –11.
Chennai
TAMIL NADU
600 066
India 
Phone  9790933426  
Fax  26591616  
Email  jollyranjith@gmail.com  
 
Details of Contact Person
Public Query  
Name  ELIZEBETH RANI V 
Designation  Professor, PhD Scholar, obstetrical & Gynaecology Nursing Department 
Affiliation  Omayal Achi College of Nursing 
Address  Omayal Achi College of Nursing 45, Ambattur Road, Puzhal Chennai-600 066
No 4A, 1st Main road, Prabu Nagar, Pallikaranai, Chennai - 100.
Chennai
TAMIL NADU
600 066
India 
Phone  9965424031  
Fax  26591616  
Email  elsam82@ymail.com  
 
Source of Monetary or Material Support  
Institute of Obstetrics & Gynaecology, Government hospital for Women & Children, Egmore, Chennai 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Elizebeth Rani V  Institute of Obstetrics & Gynaecology  Antenatal Outpatient Department/delivery / postnatal ward - Teenage Mothers
Chennai
TAMIL NADU 		 9965424031
-
elsam82@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICCR- INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  TEENAGE ANTENATAL MOTHERS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  HOSPITAL ROUTINE CARE  HOSPITAL ROUTINE CARE - 1st visit, 3rd, 6th & 9th month of pregnancy ( 4 TIMES) & DURATION 8 MONTHS. 
Intervention  TEENAGE PARENTHOOD PACKAGE  HEALTH EDUCATION THROUGH PPT, ANTENATAL EXERCISES, DIETARY ADVICES & TEENAGE PREGNANCY CARE BOOKLETS- 1st visit, 3rd, 6th & 9th month of pregnancy ( 4 TIMES) & DURATION 8 MONTHS.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  • Quantitative:
Inclusion Criteria: includes teenage primi mothers
1. Within the age group 15-19 years (as per WHO)
2. Registered within the 8 weeks of pregnancy.
3. Primigravidae with singleton pregnancy.
4. Married mothers along with the relatives.
5. Who registered and planned to deliver in the selected hospital.
6. Who can understand Tamil or English.
Qualitative:
Inclusion Criteria: Teenage antenatal mothers
1. With good/ poor maternal and fetal outcome
2. Who have the willingness & ability to express their experience of pregnancy.
3. Who differ from other participants in some variables.
4. With unexpected/uncommon outcomes.
 
 
ExclusionCriteria 
Details  1. Who have history of medical complications like gestational diabetes, hypertension, hypothyroidism/ heart disease.
2. Primigravidae undergoing abortions - only pregnancies that have crossed the period of viability.
3. Who have severe sensory or physical impairment.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maternal & Fetal outcome & Experience of Pregnancy  Maternal outcome: 7 days after intervention, 3rd, 6th & 9th Month, after delivery
Fetal Outcome: After delivery
Experience: After 2 weeks of delivery
 
 
Secondary Outcome  
Outcome  TimePoints 
EXPERIENCE OF TEENAGE PREGNANCY  AFTER 2 WEEKS OF POSTPARTUM PERIOD 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   28/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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)?  

Response - NO
Brief Summary  


 
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