| CTRI Number |
CTRI/2025/12/098819 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Acceptance and Continuation of Postpartum Intrauterine Contraceptive Device (PPIUCD) amongst postpartum women delivering in Burari Hospital Delhi |
|
Scientific Title of Study
|
Acceptance and Continuation of Postpartum Intrauterine Contraceptive Device (PPIUCD) amongst women delivering in secondary care hospital in Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Tyagi |
| Designation |
PG Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 360, Department Of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI
110002
India |
| Phone |
8130912507 |
| Fax |
|
| Email |
tyagi.ayushi08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Goswami |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 346, Department Of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI
110002
India |
| Phone |
8820404084 |
| Fax |
|
| Email |
doc.shweta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi Tyagi |
| Designation |
PG Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 360, Department Of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI
110002
India |
| Phone |
8130912507 |
| Fax |
|
| Email |
tyagi.ayushi08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Tyagi |
Maulana Azad Medical College |
Room No 360, Department Of Community Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI |
8130912507
tyagi.ayushi08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women who are eligible for PPIUCD insertion.
Women who are local residents of the study area and are available for follow-up visit at 6 weeks and 3 months after delivery. |
|
| ExclusionCriteria |
| Details |
No exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of women who accepted and received PPIUCD insertion out of women who are delivering and eligible for PPIUCD insertion in Burari Hospital, Delhi |
Within 48 hours of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of factors with acceptance of PPIUCD amongst study subjects |
Within 48 hours of delivery |
| Association of factors with continuation of PPIUCD amongst study subjects |
6 weeks & 3 months after delivery |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
20/12/2025 |
| 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="1"
Months="0"
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 aims to assess the acceptance and continuation rate of PPIUCD in postpartum females and factors associated with the acceptance and continuation of PPIUCD in Delhi. This a prospective observational study that will be carried out in PNC ward of Burari Hospital Delhi under the department of Community Medicine Maulana Azad Medical College and Associated Hospitals |