None listed
Conditions
Interventions
Intervention1: NA: NA
Intervention2: Yanae® associated with
CrossGlide™ technology: Yanae® is a CE marked
medical device indicated as a
hormone-free intrauterine
contraception in women of
childbearing
• a
CrossGlide™ inserter
technology. This inserter is an
inflatable membrane that
delivers the copper IUD into the
uterine cavity in women who are
seeking Long-Acting Reversible
Contraception (LARC)
Sponsors
Pregna International Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all the following inclusion criteria may be included: 1. 18 years old or older, in good general health and requesting contraception. 2. Meets World Health Organization (WHO) medical eligibility criteria for contraceptive use 3. Desires IUD placement 4. Negative urinary pregnancy test 5. No pelvic inflammatory disease (PID) in last 3 months 6. No contraindications to IUD insertion (see exclusion criteria below) 7. Is willing to complete survey during and after the insertion 8. Is willing to attend follow-up visit at 4-6 weeks after insertion
Exclusion criteria
Exclusion criteria: Subjects who met any of the following exclusion criteria will not be included that: 1. Malignant disease of the genital tract 2. Undiagnosed vaginal bleeding, 3. Anaemia, coagulation disorder 4. Pregnancy (known or suspected) 5. Post-partum with no menstrual return (less than 3 months) 6. Recent (less than 3 months) abortion 7. Ongoing or recent (less than 3 months) infection of the genital tract 8. Sexually transmitted disease during the last 12 months (except bacterial vaginitis, repeats herpes infection, Hepatitis B) 9. Pelvic inflammatory disease. 10. Uterine malformation (congenital or acquired) 11. Allergy to copper 12. Known pelvic tuberculosis 13. Benign and Malignant trophoblast disease 14. Distorted uterine cavity 15. Acute purulent discharge 16. Vesicovaginal fistula 17. Third degree uterine prolapse 18. Systemic Lupus Erythematosus with sever thrombocytopenia 19. Ovarian cancer 20. High individual risk of chlamydia and gonococcal infection (partner has current purulent discharge or STI) 21. Heavy/prolonged or painful menstrual bleeding, endometriosis, severe dysmenorrhea 22. AIDS, without antiretroviral therapy nor access to care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The investigation study intends to measure the correct IUD insertion Timepoint: Base line/Immediately post insertion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The investigation study intends to measure the participant pain level during IUD insertion ? 2) The investigation study intends to measure the participant satisfaction with the intervention procedure ? 3) The investigation study intends to measure the provider satisfaction with the intervention procedureTimepoint: Onsite follow-up 4-6 weeks after insertion. Distance 6 months and 12 months | — |
Countries
India
Contacts
Public ContactRanjit Gaikwad
Pregna International Ltd
Outcome results
None listed