None listed
Conditions
Interventions
Intervention1: TCu 375 Au: Duration : 5 Years with following frequency of Follow up :
1. 1st Visit after 6 months of Insertion
2. 2nd visit after 12 months of Insertion
3. 3rd Visit after 2 years
4.
Sponsors
SMB Corporation of India
SMB Corporation of India
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| IUD continuation, Failed IUD insertion as measured by inability to place the IUD correctly, Uterine perforation as measured by ultrasound,IUD expulsion, Dysmenorrhea, pregnancy, Timepoint: 1. 1st Visit after 6 months of Insertion 2. 2nd visit after 12 months of Insertion 3. 3rd Visit after 2 years 4. 4rd visit after 3 years 5. 5th visit after 4 years 6. 6th visit after 5 years | — |
Countries
India
Contacts
Public ContactDr Rohini Sehgal
AIIMS
Outcome results
None listed