Study of Effects and Safety of Gold IUD Copper T 375 Au
Phase 4
- Registration Number
- CTRI/2021/08/035479
- Lead Sponsor
- SMB Corporation of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy Females of child bearing age,
Age Group : 20 years to 35 years
Free and willing to fully comply with treatment process,
Married or in a steady relationship,
One Child interval or post delivery (PP IUCD)
ï?§Immediately after MTP/Immediately after Postpartum
5 â?? 8 day of menses
Exclusion Criteria
Any uterus pathogens like fibroid, adenomyosis, Patient with strong history of menorrhagia and have previously placed IUD, pregnancy,History of pelvic inflammatory disease, recent or remote,•Postpartum endometritis or postabortal endometritis in past 3 months Known anemia. For details refer to Study plan
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The assessment of insertion, expulsion, Pregnancy and side effects of product with patientâ??s follow-up period of 5 yearsTimepoint: The assessment of insertion, expulsion, Pregnancy and side effects of product with patientâ??s follow-up period of 5 years
- Secondary Outcome Measures
Name Time Method IUD continuation,Failed IUD insertion as measured by inability to place the IUD correctly,Uterine perforation as measured by ultrasound,IUD expulsion, Dysmenorrhea, pregnancy, <br/ ><br>Timepoint: 1.1st Visit after 6 months of Insertion <br/ ><br>2.2nd visit after 12 months of Insertion <br/ ><br>3.3rd Visit after 2 years <br/ ><br>4.4rd visit after 3 years <br/ ><br>5.5th visit after 4 years <br/ ><br>6.6th visit after 5 years <br/ ><br>