OBJECTIVE: The aim of the study was to compare 6 month expulsion rates of the copper-bearing intrauterine device (IUD) inserted after delivery of the placenta or at the 6 week postpartum visit in women undergoing caesarean section. METHODS: A parallel-group randomised trial was conducted in an Egyptian university hospital between February 2016 and December 2018. Participants were randomised to either post-placental IUD insertion or IUD insertion at the 6 week postpartum visit. Participants were followed for 12 months. Primary outcomes were IUD expulsion and the proportion of women using an IUD at 6 months. A secondary outcome was the cumulative pregnancy rate at 12 months. RESULTS:Five hundred participants were enrolled in each group. At 6 months the total expulsions were 58/416 (13.9%) in the post-placental group and 4/214 (1.9%) in the puerperal group; IUD use at 6 months was 416/478 (87.0%) in the post-placental group and 214/232 (92.2%) in the puerperal group. Data collected by phone at 12 months showed a higher cumulative pregnancy rate in the puerperal group (84/500, 16.8%) vs the post-placental group (22/500, 4.4%). IUD continuation at 12 months was higher in the post-placental group. CONCLUSION: Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group. TRIAL REGISTRATION: Clinicaltrials.gov NCT02679820.
RCT Entities:
OBJECTIVE: The aim of the study was to compare 6 month expulsion rates of the copper-bearing intrauterine device (IUD) inserted after delivery of the placenta or at the 6 week postpartum visit in women undergoing caesarean section. METHODS: A parallel-group randomised trial was conducted in an Egyptian university hospital between February 2016 and December 2018. Participants were randomised to either post-placental IUD insertion or IUD insertion at the 6 week postpartum visit. Participants were followed for 12 months. Primary outcomes were IUD expulsion and the proportion of women using an IUD at 6 months. A secondary outcome was the cumulative pregnancy rate at 12 months. RESULTS: Five hundred participants were enrolled in each group. At 6 months the total expulsions were 58/416 (13.9%) in the post-placental group and 4/214 (1.9%) in the puerperal group; IUD use at 6 months was 416/478 (87.0%) in the post-placental group and 214/232 (92.2%) in the puerperal group. Data collected by phone at 12 months showed a higher cumulative pregnancy rate in the puerperal group (84/500, 16.8%) vs the post-placental group (22/500, 4.4%). IUD continuation at 12 months was higher in the post-placental group. CONCLUSION:Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group. TRIAL REGISTRATION: Clinicaltrials.gov NCT02679820.
Authors: Mary Anne Armstrong; Tina Raine-Bennett; Susan D Reed; Jennifer Gatz; Darios Getahun; Juliane Schoendorf; Debbie Postlethwaite; Michael J Fassett; Jeffrey F Peipert; Catherine W Saltus; Maqdooda Merchant; Amy Alabaster; Xiaolei Zhou; Laura Ichikawa; Jiaxiao M Shi; Vicki Y Chiu; Fagen Xie; Shannon Hunter; Jinyi Wang; Mary E Ritchey; Giulia Chillemi; Theresa M Im; Harpreet S Takhar; Federica Pisa; Alex Asiimwe; Mary S Anthony Journal: JAMA Netw Open Date: 2022-02-01