evonorgestrel intrauterine system effects on hemoglobin and serum ferritin among anemic women in Kenya: An open label randomized trial to compare with an oral contraceptive regimen that provides supplemental ferrous fumarate tablets.

FHI 3600 个研究点目标入组 600 人开始时间: 2022年5月3日最近更新: 2023年5月29日

试验速览

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•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

•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)

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