Haematological Disorders
Conditions
Interventions
LNG IUS product
Combined oral contraceptive regimen FemiplanTM
Sponsors
FHI 360
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Prospective participants must meet the following main criteria: 1. Provide sequential oral and written consents to screen for eligibility and enroll 2. Female, aged 18-50 3. Desire to use contraception or possibly switch methods 4. Initial hemoglobin of < 126 g/L 5. Possession of a cell phone and willingness to be contacted 6. Confirmatory low hemoglobin (minimum of 87 g/L and maximum of 126 g/L) taken 1 to 4 weeks after the initial test 7. Regularly menstruating (at least once every 35 days) 8. At least 6 weeks postpartum 9. Willingness to agree to study procedures 10. Willingness to be randomized to treatment 11. Willingness to use assigned hormonal contraceptive for 18 months
Exclusion criteria
Exclusion criteria: An individual who has any of the following will be excluded from participation in this study: 1. Severe anemia (hemoglobin < 86 g/L), based on the second rapid test 2. Currently pregnant based on urine pregnancy test and failure to rule out possible pregnancy according to WHO guidelines (75) 3. Surgically sterilized or had a hysterectomy 4. Participated previously in this study by being randomized to contraceptive 5. Currently using a subdermal contraceptive implant and does not wish to have it removed 6. Currently using an LNG IUS 7. Currently receiving treatment for anemia 8. Any of the following previously diagnosed disorders: hemosiderosis, hemochromatosis, hemolytic anemia 9. Known allergic reactions to oral contraceptives or LNG IUS 10. Currently receiving an investigational (unapproved) drug in another study 11. Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe 12. Intending to become pregnant in the next 18 months 13. Mucopurulent cervicitis 14. Pelvic inflammatory disease 15. Other medical contraindications to treatment, according to WHO Medical Eligibility Criteria (categories 3 or 4)(9)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in hemoglobin | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum ferritin changes over time in the randomized arms | — |
Countries
Kenya
Contacts
Public ContactJulius Oyugi
UNITID
Outcome results
None listed