Health Condition 1: null- Heavy menstrual bleeding in women in 18-45 years age group, assessed in terms of PBAC score (pictoral blood loss assessment chart).
Conditions
Interventions
Intervention1: Intravaginal hormonal ring (Nuvaring)-: Intravaginal hormonal ring (Nuvaring)- (releasing
15 µg ethinylestradiol + 120 µg etonorgestrel/day)
Once a month insertion for 3 months
Co
Sponsors
Department of Obstetrics Gynaecology Armed Forces Medical CollegePune
Eligibility
Inclusion criteria
Inclusion criteria: All women in the age group 18-45 years ,having heavy menstrual bleeding due to 1. AUB â??O, 2. AUB-E and/or 3. AUB-L(fibroid as per PALM-COEIN Classification.
Exclusion criteria
Exclusion criteria: Women having heavy menstrual bleeding due to 1. AUB-Polyp 2. AUB-Adenomyosis 3. AUB-Leiomyoma (fibroids >2cm) 4. AUB-Malignancy or hyperplasia 5. AUB-Coagulopathy 6. AUB-Iatrogenic 7. AUB-Not yet classified Women with medical conditions where COC pills/ Nuvaring are contraindicated like 8. Jaundice, 9. DM, 10. HT, 11. Migraine, 12. Epilepsy , 13. H/o thromboembolism, 14. Breast or genital tract malignancies, 15. Genital prolapse or infections 16. Stroke 17. H/o of smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of hormonal drug delivery via intravaginal route vs oral route in control of heavy menstrual bleeding, in terms of change in PBAC Score from baseline to after three months of treatment.Timepoint: From baseline to after three months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare side-effects, change in haemoglobin levels and weight of patient from baseline to after three months of treatment.Timepoint: From baseline to after three months of treatment. | — |
Countries
India
Contacts
Public ContactDr Meenakshi K Bharadwaj
Armed Forces Medical College, Pune.
Outcome results
None listed