Lara Ricalde Roger, Menocal Tobías Gerardo, Ramos Pérez Carlos, Velázquez Ramírez Norma
Departamento de planificación familiar del Instituto Naciónal de Perinatología. Lomas Virreyes, México.
Ginecol Obstet Mex. 2006 Jun;74(6):306-11.
To evaluate safety and effectiveness of the intrauterine device Multiload Cu375 compared with the TCu 380A inserted in the postpartum period.
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.
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.
The intrauterine device MLCu 375 is as safe and effective as the TCu380A when they are inserted in the postpartum period.
评估产后置入的多负载铜375宫内节育器与TCu 380A宫内节育器的安全性和有效性。
在国家围产医学研究所进行的一项随机对照研究中，将MLCu 375和Tcu 380A宫内节育器置入157名自愿接受且事先签署知情同意书的患者体内。宫内节育器置入有四种情况：阴道分娩后10分钟内、剖宫产时（胎盘娩出后立即置入）以及剖宫产后产后置入（在10分钟至48小时的时间段内）。所有置入均使用环形钳。在置入后1小时至24小时，进行腹部超声检查以评估节育器上端至子宫腔底部的距离。随访安排在3、6、9和12个月。估计一年时停用的净累积生命表事件发生率。
MLCu 375的脱落率为10.4，TCu 380A的脱落率为7.7，它们不受宫内节育器置入时间、宫颈扩张情况以及节育器至子宫腔底部距离的影响。因出血和疼痛的取出率分别为4.9和4.8，非医学原因的取出率分别为3.7和4.9。MLCu 375组有1例生殖器感染。无妊娠及子宫穿孔情况。一年的续用率分别为77.1和82.6。比较率无统计学显著差异。
产后置入时，MLCu 375宫内节育器与TCu380A一样安全有效。
