None listed
Conditions
Interventions
Intervention1: Levonorgesterol Intrauterine Device (LNG IUS) - Eloira insertion: Women attending Obstetrics and Gynecology OPD at AIIMS Rishikesh fulfilling the above inclusion and exclusion criteria
Sponsors
Pregna International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Parous and nulliparous women choosing LNG IUS for interval contraception after Cafetaria method with GATHER approach, 2. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1 .Known or suspected Pregnancy 2. Current Pelvic infection 3. Uterine bleeding of unknown etiology, 4. Post renal transplant patients 5. Acute liver disease or liver tumor (benign or malignant) 6. Known or suspected uterine or cervical neoplasia 7. Chorio-carcinoma patients on follow-up 8. Subjects at increased risk for infectious endocarditis (prosthetic heart valves, rheumatic heart disease, previous endocarditis) 9. Women with a prior Tubectomy/trans cervical tubal sterilization procedure (e.g., Essure) 10. Postmenopausal woman 11. Use of another hormonal contraceptive within 30 days of levonorgestrel intrauterine system placement for the study 12. Vaginal delivery, cesarean delivery, or abortion within six weeks prior to levonorgestrel intrauterine system insertion (uterus should be fully involuted before insertion). 13. Women with a uterine cavity that measures less than 6 cm or greater than 10 cm 14. Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity 15. Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy 16. Postpartum endometritis or infected abortion in the past 3 months 17. Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past 18. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections 19. Conditions associated with increased susceptibility to pelvic infections 20. A previously inserted intrauterine device that has not been removed 21. Hypersensitivity to any component of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate contraceptive efficacy of LNG IUS (Eloira)Timepoint: Phase I – Consenting and Screening phase. Phase II – Insertion phase Phase III – Follow up phase (5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate following factors in women using LNG IUS (Eloira) 1. Uterine Artery pattern and endometrial thickness as per Doppler scan 2. Changes in menstrual bleeding pattern 3. Changes in menstrual pain 4. Expulsion rate 5. Incidence of adverse events 6. Ectopic pregnancies with Eloira 7. Evaluate improvement in Hemoglobin level 8. Any change in serum lipid profile 9. Measure serum Levonorgestral levelTimepoint: Outcomes will be assessed at 1 Month 3 month 6 Months 1 year 2year 3 year 4 year 5 year for Nulliparous women 1 month 3 month 6 month 1 year | — |
Countries
India
Contacts
Public ContactDr Latika Chawla
AIIMS Rishikesh
Outcome results
None listed