Randomized assignment to copper IUD or depot-medroxyprogesterone acetate: feasibility of enrollment, continuation and disease ascertainment

• Published in: Contraception (Stoneham) 2005-09, Vol.72 (3), p.187-191
• Main Authors: Feldblum, Paul J., Caraway, Jennifer, Bahamondes, Luis, El-Shafei, Mohamed, Quan Ha, Do, Morales, Edwin, Wevill, Silver, Condon, Sean
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Biological and medical sciences; Birth control; Chlamydia Infections; Contraceptive Agents, Female - administration & dosage; Copper IUD; Depot-medroxyprogesterone acetate; Feasibility Studies; Female; Genital system. Reproduction; Gonorrhea; Gynecology. Andrology. Obstetrics; Humans; Intrauterine Devices, Copper - adverse effects; Medical sciences; Medroxyprogesterone Acetate - administration & dosage; Other methods of contraception. Sterilization; Pelvic inflammatory disease; Pelvic Inflammatory Disease - etiology; Pharmacology. Drug treatments; Pilot Projects; Pilot study; Randomized controlled trial
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2005.03.006

We conducted a feasibility study to enroll and follow family planning acceptors who were randomly assigned to use an intrauterine device (IUD) or injectable depot-medroxyprogesterone acetate (DMPA). Centers in Brazil, Guatemala, Egypt and Vietnam aimed to enroll 100 participants per site. Enrolled women were randomly assigned to have inserted a TCu 380A IUD, or to receive injections of 150 mg of DMPA every 3 months, and scheduled for up to 12 months of follow-up. We tested for cervical infection at first and final visits, and examined for signs of pelvic inflammatory disease (PID) at each visit. The sites screened 555 women and enrolled 368. Two women (0.5%) had three discomfort signs of PID during follow-up. The prevalence of gonorrhea at each woman's final follow-up visit was 0.5%, and the prevalence of chlamydia at final visit was 5.4%. Sixty-eight percent of women either completed 12 months of observation with their assigned method or were still using their method at the end of the study. A larger, definitive clinical trial appears feasible. The majority of women we approached agreed to participate; nearly 400 women were enrolled; two thirds continued to use their assigned method until study closeout; and the STI risk was moderate.