Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya

Launched by FHI 360 · Jan 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how two different birth control methods can affect women who have mild to moderate anemia, a condition where you have lower than normal levels of hemoglobin in your blood. The trial involves around 600 women between the ages of 18 and 50 who are looking for contraception. Participants will be randomly assigned to either a levonorgestrel intrauterine system (IUS), which is a type of long-term birth control placed in the uterus, or a combined oral contraceptive pill that also includes iron supplements. The main focus is to see if women using the IUS will experience a greater improvement in their hemoglobin levels compared to those taking the oral contraceptive.

To be eligible for this trial, women must be between 18 and 50 years old, want to use birth control, and have a confirmed low hemoglobin level. They should also be able to attend follow-up visits and use the assigned method for 18 months. Participants can expect regular check-ins to monitor their health and blood levels throughout the study. It’s important to know that women with severe anemia, those who are currently pregnant, or have certain medical conditions will not be able to participate. This study aims to provide valuable insights into how different contraceptive options can impact women's health, especially for those dealing with anemia.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Provide sequential oral and written consents to screen for eligibility and enroll
• • Female, aged 18-50
• • Desire to use contraception or possibly switch methods
• • Possession of a cell phone and willingness to be contacted
• • Confirmatory low hemoglobin (minimum of 87 g/L and maximum of 126 g/L) taken 1 to 4 weeks after the initial test
• • Regularly menstruating (at least once every 35 days)
• • At least 6 weeks postpartum
• • Willingness to agree to study procedures
• • Willingness to be randomized to treatment
• • Willingness to use assigned hormonal contraceptive for 18 months
• Exclusion Criteria:
• • Severe anemia (hemoglobin \< 86 g/L)
• • Currently pregnant based on urine pregnancy test and failure to rule out possible pregnancy according to WHO guidelines
• • Surgically sterilized or had a hysterectomy
• • Participated previously in this study by being randomized to contraceptive
• • Currently using a subdermal contraceptive implant and does not wish to have it removed
• • Currently using an LNG IUS
• • Currently receiving treatment for anemia
• • Any of the following previously diagnosed disorders: hemosiderosis, hemochromatosis, hemolytic anemia
• • Known allergic reactions to oral contraceptives or LNG IUS
• • Currently receiving an investigational (unapproved) drug in another study
• • Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe
• • Intending to become pregnant in the next 18 months
• • Mucopurulent cervicitis
• • Pelvic inflammatory disease
• • Other medical contraindications to treatment, according to WHO Medical Eligibility Criteria (categories 3 or 4)