OBJECTIVES: 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). METHODS: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. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
OBJECTIVES: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Elizabeth M Stringer; Christine Kaseba; Jens Levy; Moses Sinkala; Robert L Goldenberg; Benjamin H Chi; Inutu Matongo; Sten H Vermund; Mulindi Mwanahamuntu; Jeffrey S A Stringer Journal: Am J Obstet Gynecol Date: 2007-08 Impact factor: 8.661
Authors: G Justus Hofmeyr; Charles S Morrison; Jared M Baeten; Tsungai Chipato; Deborah Donnell; Peter Gichangi; Nelly Mugo; Kavita Nanda; Helen Rees; Petrus Steyn; Douglas Taylor Journal: Gates Open Res Date: 2018-03-13
Authors: N E Quispe Calla; R D Vicetti Miguel; P N Boyaka; L Hall-Stoodley; B Kaur; W Trout; S D Pavelko; T L Cherpes Journal: Mucosal Immunol Date: 2016-03-23 Impact factor: 7.313
Authors: Deborah Bartz; Rie Maurer; Jessica Kremen; Jennifer M Fortin; Elizabeth Janiak; Alisa B Goldberg Journal: Contracept Reprod Med Date: 2017-01-07