At enrolment, women were randomly assigned (1:1:1) to the DMPA-IM group, Copper IUD group, or LNG implant group. Participants received a Cu IUD (Optima TCu380A; Injeflex, Sao Paolo, Brazil), an LNG implant (
Jadelle; Bayer, Turku, Finland) or an injection of 150 mg/mL DMPA-IM (
Depo Provera; Pfizer, Puurs, Belgium), which was provided on site at enrolment and for the DMPA-IM group at every 3-monthly follow-up visit up to 18 months.
Ethics review committees at each study site, FHI 360, and the World Health Organization (WHO) approved the study protocol. Women provided written informed consent in a language of their choice prior to the conduct of any study related procedures.
Outcomes: The primary outcome of this secondary analysis is weight change from study enrolment to the final visit at study month 12–18.
Beksinska M., Issema R., Beesham I., Lalbahadur T., Thomas K., Morrison C., Hofmeyr G.J., Steyn P.S., Mugo N., Palanee-Phillips T., Ahmed K., Nair G., Baeten J.M, & Smit J. (2021). Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial. EClinicalMedicine, 34, 100800.