OBJECTIVE: To evaluate safety and effectiveness of the intrauterine device Multiload Cu375 compared with the TCu 380A inserted in the postpartum period. PATIENTS AND METHODS: In a randomized comparative study carried out in the National Perinatology Institute, intrauterine devices MLCu 375 and Tcu 380A were inserted to 157 patients who voluntary accepted, and previously signed informed consent. There were four instances for the intrauterine devices insertion: within 10 minutes after vaginal delivery, during cesarean section (immediate postplacental insertion) and postpartum-postcesarean insertion (in the time range of 10 min to 48 h). All insertions were made with ring forceps. From 1 h to 24 h later, abdominal ultrasound examinations were performed to assess the distances between the upper part of the device to the fundus of uterine cavity. Follow up visits were scheduled at 3, 6, 9 and 12 months. Net cumulative life table event rates of discontinuations were estimated at one year. RESULTS: The expulsion rates were 10.4 for the MLCu 375 and 7.7 for the TCu 380A and they were not influenced by the moment of the intrauterine device insertion, not by the cervical dilatation, neither by the distance of the intrauterine device to the fundus of uterine cavity. The removal rates for bleeding and pain were 4.9 and 4.8, the removal rates for non medical reasons were 3.7 and 4.9 respectively. There was one case of genital infection in the MLCu 375 group. There were no pregnancies, nor uterine perforation. The one year continuation rates were 77.1 and 82.6 respectively. There were no statistical significant differences in the comparative rates. CONCLUSIONS: The intrauterine device MLCu 375 is as safe and effective as the TCu380A when they are inserted in the postpartum period.
RCT Entities:
OBJECTIVE: To evaluate safety and effectiveness of the intrauterine device Multiload Cu375 compared with the TCu 380A inserted in the postpartum period. PATIENTS AND METHODS: In a randomized comparative study carried out in the National Perinatology Institute, intrauterine devices MLCu 375 and Tcu 380A were inserted to 157 patients who voluntary accepted, and previously signed informed consent. There were four instances for the intrauterine devices insertion: within 10 minutes after vaginal delivery, during cesarean section (immediate postplacental insertion) and postpartum-postcesarean insertion (in the time range of 10 min to 48 h). All insertions were made with ring forceps. From 1 h to 24 h later, abdominal ultrasound examinations were performed to assess the distances between the upper part of the device to the fundus of uterine cavity. Follow up visits were scheduled at 3, 6, 9 and 12 months. Net cumulative life table event rates of discontinuations were estimated at one year. RESULTS: The expulsion rates were 10.4 for the MLCu 375 and 7.7 for the TCu 380A and they were not influenced by the moment of the intrauterine device insertion, not by the cervical dilatation, neither by the distance of the intrauterine device to the fundus of uterine cavity. The removal rates for bleeding and pain were 4.9 and 4.8, the removal rates for non medical reasons were 3.7 and 4.9 respectively. There was one case of genital infection in the MLCu 375 group. There were no pregnancies, nor uterine perforation. The one year continuation rates were 77.1 and 82.6 respectively. There were no statistical significant differences in the comparative rates. CONCLUSIONS: The intrauterine device MLCu 375 is as safe and effective as the TCu380A when they are inserted in the postpartum period.
Authors: Blair G Darney; Sandra G Sosa-Rubi; Edson Servan-Mori; Maria I Rodriguez; Dilys Walker; Rafael Lozano Journal: Contraception Date: 2016-01-30 Impact factor: 3.375