| CTRI Number |
CTRI/2024/07/070627 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of subcutaneous versus intramuscular DMPA as a choice of contraceptive method to see the difference in efficacy of dmpa in both modes of injections among reproductive women |
|
Scientific Title of Study
|
A comparison of subcutaneous versus intramuscular depot medroxyprogesterone acetate as a choice of contraceptive method |
| 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 Neha kumari |
| Designation |
postgraduation resident |
| Affiliation |
maulana azad medical college |
| Address |
academic section maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
8083889565 |
| Fax |
|
| Email |
nehagmc2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Y M MALA |
| Designation |
Director professor and H O D Department of obstetrics and gynecology Maulana azad medical college |
| Affiliation |
maulana azad medical college |
| Address |
HOD office maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9968604347 |
| Fax |
|
| Email |
ym_mala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Y M MALA |
| Designation |
Director professor and H O D Department of obstetrics and gynecology Maulana azad medical college |
| Affiliation |
maulana azad medical college |
| Address |
HOD office maulana azad medical college
New Delhi
DELHI
110002
India |
| Phone |
9968604347 |
| Fax |
|
| Email |
ym_mala@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE bahadur shah zafar marg new delhi INDIA pin 110002 |
|
|
Primary Sponsor
|
| Name |
Dr neha kumari |
| Address |
U 144 sapra villa 3rd floor laxmi nagar delhi pin 110092 |
| 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 neha kumari |
lok nayak hospital NEW DELHI |
department of obstetrics and gynecology jawaharlal nehru marg near delhi gate new delhi 110002
New Delhi
DELHI |
8083889565
nehagmc2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| maulana azad medical college and associated hospital INSTITUTIONAL ETHICS COMMITTEE ( F.1/IEC/MAMC/MD/MS/108/01/2024/No.176 ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POST MENSTRUAL WOMEN POST ABORTAL WOMEN 6 WEEKS POST DELIVERY WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
women receiving intramuscular DMPA 150 mg in 1 ml every 3 monthly |
follow up for 12 months |
| Intervention |
women receiving subcutaneous DMPA 104 mg in 0.65 ml every 3 monthly |
follow up for 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women giving informed consent for receiving DMPA and ready to follow up visits every 3 months and are falling in category 1 or 2 of WHO Medical Eligibility Criteria for injection DMPA in following phases;
a. Post menstrual
b. Post abortal
c. 6 weeks post delivery.
|
|
| ExclusionCriteria |
| Details |
Women with prior history of menstrual irregularities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Percentage of women willing to continue subcutaneous Depot medroxyprogesterone acetate (DMPA) as contraceptive method.
(2) Percentage of women willing to continue intramuscular DMPA as contraceptive method
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Percentage of women having side effects with subcutaneous DMPA.
(2) Percentage of women having side effects with intramuscular DMPA.
|
12 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
With the help of Random allocation
software 2.0, recruited patients will be allocated into 2 groups. Women in reproductive
age group (18-45 years) attending family planning clinic in Department of
Obstetrics and Gynecology, Lok Nayak Hospital, willing to use injection DMPA
and fulfilling the inclusion and exclusion criteria will be recruited in the
study. After obtaining an informed consent, a detailed demographic, menstrual, obstetrical,
past medical and surgical history will be taken. General physical and local examination
will be done. Detailed contact information will be taken for further follow up.
Group 1 will be receiving
subcutaneous and Group 2 will be receiving intramuscular DMPA injection.
Subcutaneous DMPA is given in the
back of the upper arm, in the abdomen (but not at the navel) and on the front
of the thigh. It is given through Uniject prefilled injection system. The dose
is 104 mg in 0.65 ml of injectable suspension.
Intramuscular DMPA is given deep
into the hip (ventrogluteal muscle), the upper arm (deltoid muscle), or the
buttocks (upper outer portion of gluteal muscle), whichever the women prefers.
It is given through a 2 ml syringe and 21-23 gauge intramuscular needle after
loading the dose through glass vial. The dose is 150 mg in 1 ml of aqueous
solution as a single dose.
Next injection
appointment date will be noted for each enrolled patients for follow up.
The women will be followed up for
second injection and will perform detailed follow up surveys at the second injection
or upon discontinuation. History will be taken at next 3 monthly visit of the
patient regarding any side-effects (Weight gain, headache, breast tenderness,
prolonged and heavy bleeding, intermenstrual bleeding, spotting, oligomenorrhea
and amenorrhea), whether willing to continue the contraceptive injection, any
unexpected pregnancy (contraceptive failure), reason for discontinuation of
subcutaneous vs intramuscular DMPA injection.
They will be contacted at baseline
and after 3 months to know if there are any practical barriers to continuation. Outcomes will be measured as
(1)User acceptability and continuation
rates
(2)Side effects Relevant statistical analysis will be performed using
SPSS-25 version
|