| CTRI Number |
CTRI/2024/08/072917 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study to evaluate the insertion of postpartum intrauterine contraceptive device with the new inserter versus Kelly forceps . |
|
Scientific Title of Study
|
A prospective, interventional, comparative study to evaluate the insertion of postpartum intrauterine contraceptive device using the dedicated inserter versus Kelly forceps. |
| 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 Palak |
| Designation |
Junior resident |
| Affiliation |
Postgraduate institute of medical education and research ,Chandigarh |
| Address |
Department of obstetrics and gynaecology ,Nehru hospital ,Postgraduate Institute Of Medical Education And Research , Sector 12,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8607465160 |
| Fax |
|
| Email |
palak180299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Jain |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research, Chandigarh |
| Address |
Department of obstetrics and gynaecology , Nehru hospital, Postgraduate Institute Of Medical Education And Research , sector12,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209352 |
| Fax |
|
| Email |
drvanitajain@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita jain |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research, Chandigarh |
| Address |
Department of obstetrics and gynaecology ,Nehru hospital ,Postgraduate Institute Of Medical Education And Research, sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209352 |
| Fax |
|
| Email |
drvanitajain@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology , Postgraduate institute of medical education and research ,sector 12 , Chandigarh 160012. |
|
|
Primary Sponsor
|
| Name |
Dr Palak |
| Address |
Department of obstetrics and gynaecology, Nehru hospital, Postgraduate Institute Of Medical Education And Research ,Sector 12 ,160012. |
| Type of Sponsor |
Other [Self] |
|
|
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 Palak |
Postgraduate institute of medical education and research,Chandigarh 160012 |
Department of obstetrics and gynaecology, Postgraduate Institute Of Medical Education And Research, Chandigarh 160012
Chandigarh
CHANDIGARH |
8607465160
palak180299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural) , Post Graduate Institute Of Medical Education And Research , Chandigarh . |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O909||Complication of the puerperium, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dedicated inserter .
|
Insertion of contraceptive device with dedicated inserter which is long and does not need a specific instrument .
Duration -Follow up after 6 weeks .
Frequency - maximum two trials allowed . |
| Comparator Agent |
Kelly forceps |
Insertion of contraceptive device with Kelly forceps which is a conventional instrument .
Duration - follow up after 6 weeks
Frequency - maximum two trials allowed . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Primiparous or multiparous women delivering vaginally and willing for long term reversible contraception.(Including instrumental deliveries )
2 Consenting and willing for Copper T IUD.
3 Patients who fulfil the WHO Medical eligibility criteria for contraceptive use
4 Insertion within 48 hours following delivery. |
|
| ExclusionCriteria |
| Details |
1 women not willing to participate
2 women with pelvic inflammatory disease
3 cesarean delivery
4 peri partum fever
5 women with anaemia , thrombocytopenia
6 women with postpartum haemorrhage
7 women with chorioamnionitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess the correct fundal placement of PPIUCD in the uterus.
2 To assess provider’s satisfaction in terms of ease of insertion using five- point LIKERT scale.
|
Immediately after insertion and at 6 weeks postpartum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess patients’ satisfaction and perception of pain using three-point LIKERT scale.
2 Confirmation of PPIUCD retention by a six-week follow-up.
|
6 weeks post partum |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study is a prospective , interventional , comparative study to evaluate the insertion of postpartum intrauterine contraceptive device using the dedicated inserter versus Kelly forceps which is the conventional method ; in terms of fundal placement , ease of insertion for doctor , patient’s perception of pain and any complications . |