FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076485 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO STUDY THE ACCEPTANCE, CONTINUATION AND SAFETY OF INTRA UTERINE CONTRACEPTIVE DEVICES AFTER DELIVERY 
Scientific Title of Study   To Study the Acceptance, Continuation and Safety of Intra uterine Contraceptive Devices-PPIUCD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SIDDARTH CHOUDHARY 
Designation  POST MBBS PRIMARY DNB RESIDENT 
Affiliation  Bhagat Phool Singh Govt. Medical College for Women 
Address  Department of Obstetrics and Gynaecology, BPS GMC, Khanpur Kalan, Sonipat
Department of Obstetrics and Gynaecology, BPS GMC, Khanpur Kalan, Sonipat
Sonipat
HARYANA
131305
India 
Phone  7823014943  
Fax    
Email  siddharthhchoudhary007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR VIJAYATA SANGWAN  
Designation  MBBS, MS (Obstetrics and Gynaecology) 
Affiliation  Bhagat Phool Singh Govt. Medical College for Women 
Address  Department of Obstetrics and Gynaecology BPS GMC FOR WOMEN, KHANPUR KALAN DISTRICT - SONEPAT
Khanpur Kalan, Sonipat

HARYANA
131305
India 
Phone    
Fax    
Email  vsangwan03@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SIDDARTH CHOUDHARY 
Designation  POST MBBS PRIMARY DNB RESIDENT 
Affiliation  Bhagat Phool Singh Govt. Medical College for Women 
Address  Department of Obstetrics and Gynaecology, BPS GMC FOR WOMEN, KHANPUR KALAN DISTRICT - SONEPAT
Khanpur Kalan, Sonipat

HARYANA
131305
India 
Phone  7823014943  
Fax    
Email  siddharthhchoudhary007@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Bhagat Phool Singh Government Medical College for Women 
Address  Khanpur Kalan, Sonipat 131305 
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 SIDDARTH CHOUDHARY   Bhagat Phool Singh Govt. Medical College for Women  Department of Obstetrics and Gynaecology, BPS GMC, Khanpur Kalan, Sonipat
Sonipat
HARYANA 		 7823014943

siddharthhchoudhary007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE   NOT APPLICABLE  
Intervention  PPIUCD Insertion   After delivery, an intrauterine contraceptive device will be kept and patient will be further followed up. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All pregnant Women who are admitted for delivery at BPS GMC (W) Khanpur Kalan
● Willing to participate in study. 
 
ExclusionCriteria 
Details  Patients not willing to participate in study.
1. History of antepartum haemorrhage.
2. Patients with suspicion of chorio- amnionitis.
3. Women with uterine anomalies like Bicornuate, Septate Uterus or Uterine Myomas .
4. Manual removal of placenta.
5. Sero positive Patients.
6. Patients on ATT treatment.
7. Deliveries With unresolved postpartum haemorrhage or postpartum Uterine atony requiring
additional oxytocic agents in addition to AMTSL. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rate of acceptance of PPIUCD.
● Rate of continuation of PPIUCD.
● Incidence of development of side effects and complications of PPIUCD. 		 Within 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Awareness of PPIUCD among pregnant females.
● Most common cause of acceptance and rejection.
● Complications associated with PPIUCD
● Obstetrics outcomes in females who denied for PPIUCD insertion in the period of 1 year. 		 Within 1 year  
 
Target Sample Size   Total Sample Size="355"
Sample Size from India="355" 
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)   16/11/2024 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Adequate contraception in the postpartum period is required for spacing between childbirths and for prevention of unintended pregnancy. The major barrier in contraception use after pregnancy is returning back to the healthcare center in view of familial responsibilities. Intrauterine contraceptive devices are the most suitable method for contraception in the postpartum period because they need less hospital visits. Acceptability is a barrier in our country due to lack of knowledge, misperceptions and concerns about potential complications. This study aims to do assessment of the awareness of women regarding PPIUCD, then will study about continuation and complications of the same.


 
Close