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CTRI Number  CTRI/2025/09/094304 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Video teaching for couples during pregnancy to increase Copper-T acceptance after delivery among mothers giving birth for the first time in Pondicherry 
Scientific Title of Study   Efficacy of antenatal couple-based video-assisted teaching on Post-Partum Intra Uterine Contraceptive Device (PPIUCD) uptake among Primipara mothers in Tertiary care Hospital, Pondicherry: Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Senjuti Sarkar 
Designation  Student 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room no. 420 Old currie house College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.

Pondicherry
PONDICHERRY
605006
India 
Phone  8637068018  
Fax    
Email  senjutisarkar99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Kanimozhi K 
Designation  Tutor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room no. 101 College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.

Pondicherry
PONDICHERRY
605006
India 
Phone  7904092534  
Fax    
Email  kanibaskar@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Mrs Kanimozhi K 
Designation  Tutor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Room no. 101 College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.

Pondicherry
PONDICHERRY
605006
India 
Phone  7904092534  
Fax    
Email  kanibaskar@yahoo.in  
 
Source of Monetary or Material Support  
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Murali S  Jawaharlal Institute of Postgraduate Medical Education and Research   Room 03,Women and Child Health Building, Department of Obstetrics and Gynecology
Pondicherry
PONDICHERRY 		 8940760837

muralidraiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE -INTERVENTIONAL STUDIES JIPMER, PUDUCHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Couple-based video-assisted teaching on PPIUCD  Primigravidae women coming with their husbands will receive couple-based video-assisted teaching on PPIUCD along with routine antenatal health education during their antenatal visit 
Comparator Agent  Routine antenatal health education  Primigravidae mothers will receive routine antenatal health education during their antenatal visit. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Primigravidae women who have completed 36 weeks of gestation and are attending antenatal OPD
along with their husbands, planned for delivery at JIPMER and can understand either Tamil or English language. 
 
ExclusionCriteria 
Details  Primigravida women who are contraindicated for PPIUCD, diagnosed with heart disease or any known infections, had a history of previous ectopic
pregnancy, fibroid complicating pregnancy, known allergy to copper, had prolonged PROM, chorioamnitis, and development of PPH following delivery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of antenatal couple-based video-assisted teaching on PPIUCD uptake among Primipara mothers.  After delivery during postpartum period.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="442"
Sample Size from India="442" 
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)   15/09/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a randomized controlled trial to assess the efficacy of couple-based video-assisted teaching on the uptake of Post-Partum Intrauterine Contraceptive Device among primipara mothers attending antenatal outpatient department of a tertiary care hospital in Pondicherry. Eligible primigravida mothers and their husbands, who meet the inclusion criteria, will be recruited after obtaining written informed consent. Participants will be randomly allocated to either the experimental or control group using the Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) method. Baseline socio-demographic and clinical variables will be collected using a structured proforma. In the experimental group, couples will receive routine antenatal counseling along with an 8-minute couple-based video-assisted teaching session in English or Tamil on PPIUCD, validated by subject experts. The video explains the meaning, mechanism of action, benefits, timing of insertion, misconceptions, and follow-up care regarding PPIUCD, with opportunities for clarification of doubts. The control group will receive routine antenatal counseling only. The primary outcome is the uptake of PPIUCD, assessed through labor records and case sheets after delivery. This study aims to determine whether involving spouses through video-assisted health teaching can increase awareness and acceptance of PPIUCD as a postpartum family planning method.

 
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