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CTRI Number  CTRI/2015/09/006221 [Registered on: 28/09/2015] Trial Registered Prospectively
Last Modified On: 23/09/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of visibility of strings of Cu T 380 A and Cu 375 intra uterine contraceptive device. 
Scientific Title of Study   Visibility of strings after post placental insertion of Cu T 380 A and Cu 375 intra uterine contraceptive device: A randomized comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavita Agarwal 
Designation  Assistant Professor 
Affiliation  Safdarjung Hospital 
Address  Department of Obstetrics and Gynaecology Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone  9990167888  
Fax    
Email  drku93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavita Agarwal 
Designation  Assistant Professor 
Affiliation  Safdarjung Hospital 
Address  Department of Obstetrics and Gynaecology Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone  9990167888  
Fax    
Email  drku93@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kavita Agarwal 
Designation  Assistant Professor 
Affiliation  Safdarjung Hospital 
Address  Department of Obstetrics and Gynaecology Safdarjung Hospital New Delhi

New Delhi
DELHI
110029
India 
Phone  9990167888  
Fax    
Email  drku93@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung Hospital, Yusuf Sarai, In front of AIIMS, New Delhi- 110029 
 
Primary Sponsor  
Name  Safdarjung Hospital 
Address  Deaprtment of Obstetrics and Gynaecology Safdarjung Hospital New Delhi- 110029 
Type of Sponsor  Government medical college 
 
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 Kavita Agarwal  Safdarjung Hospital  Department of Obstetrics and Gynaecology, Safdarjung Hospital, Yusuf Sarai, In front of AIIMS, New Delhi- 110029
New Delhi
DELHI 		 9990167888

drku93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
V.M.M.C. and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  women posted for cesarean section and desirous of post partum contraception,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cu- 375  Intra-uterine contraceptive device used worldwide for providing contraception for 5 years with string length 19.4 cms 
Comparator Agent  Cu-T 380A  Intra-uterine contraceptive device used world wide for providing contraception for 10 years with string length 11.5 cm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women fulfilling following criteria will be eligible for study.
1.Women desirous of postpartum contraception for less than or upto 5 years.
2.Women posted for elective / emergency caesarean section
3.Women willing to come for follow up
 
 
ExclusionCriteria 
Details  1.More than 18 hours of rupture of membranes before delivery.
2.Any evidence of chorioamnionitis
3.Antepartum hemorrhage or postpartum hemorrhage
4.Fever in recent antepartum period
5.Women in Medical eligibility criteria category 3 or 4 of Copper T insertion.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visibility of strings at follow up visits  Visibility of strings at 1 week, 6 weeks post cesarean  
 
Secondary Outcome  
Outcome  TimePoints 
1.Clinical outcome including pain, bleeding, pelvic infection, expulsion.
2.Requirement of Ultrasound , X- ray, invasive procedure
3.Complications like uterine perforation.
4.Reasons for non visibility of strings.
 		 all secondary outcomes to be evaluated at 1 week and 6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 4 
Date of First Enrollment (India)   30/09/2015 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Post placental insertion of Cu375 and CuT380A intra uterine contraceptive device will be done transcesarean within 10 minutes after delivery of placenta. Cu T will be inserted using Kelly’s forcep at fundus of uterus and strings will be directed towards the internal os. The women will be observed in post operative ward for 72 hours post insertion.

The subject will be advised to return for scheduled follow up visit at 1 week  and 6 weeks post Cu T insertion. At follow up visit, women will be interviewed in a pre structured proforma about any complaints, menstrual history, general physical , pelvic examination will be done, availability of thread will be noted, requirement of ultrasound or invasive procedure and their findings or any complications will be recorded. 

 
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