A randomized comparison of a novel nitinol-frame low-dose-copper intrauterine contraceptive and a copper T380S intrauterine contraceptive
Autor: | Katja Jakopič, Pepita Taneska, Kristina Drusany Starič, Adolf Lukanovic, Borut Kobal, Branko Cvjetičanin, Andrej Zore |
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Rok vydání: | 2017 |
Předmět: |
Adult
medicine.medical_specialty Adolescent medicine.medical_treatment Uterine perforation Population Pain Intrauterine device Young Adult 03 medical and health sciences 0302 clinical medicine Pregnancy Laparotomy Alloys medicine Humans Levonorgestrel 030212 general & internal medicine education Laparoscopy Pain Measurement education.field_of_study 030219 obstetrics & reproductive medicine medicine.diagnostic_test Obstetrics business.industry Obstetrics and Gynecology Intrauterine Device Expulsion Intrauterine Devices Copper medicine.disease Surgery Parity Contraception medicine.anatomical_structure Reproductive Medicine Patient Satisfaction Hysteroscopy Female Uterine cavity business medicine.drug |
Zdroj: | Contraception. 95:544-548 |
ISSN: | 0010-7824 |
Popis: | We sought to compare VeraCept (VC175), a novel nitinol intrauterine contraceptive (IUC) with 175 square-mm of copper surface area, to a copper T380S IUC.We enrolled parous women into a randomized subject-blinded comparison of VC175 and a copper T380S in a 2:1 fashion at a single clinic. The primary outcomes were total adverse events and continuation at 12 months. We also examined pain on insertion, ease of placement, expulsion, tolerability and pregnancy. Subjective ratings were on a 5-point Likert scale (0, no pain to 5, worst pain). We followed subjects through 24-month follow-up.We enrolled 300 women with 199 randomized to VC175 and 101 to the T380S. Insertion was successful in 198 subjects for VC175 and 100 for the T380S. Mean age was 25 years (range 18, 41), and median parity was 2 (range 1, 8), with 39% having only had Cesarean deliveries. No subjects developed clinical infection or reported serious adverse events. In the VC175 and T380S groups, mean pain at insertion was 1.4 and 2.4, respectively (p.01). At the 12-month primary endpoint for VC175 and T380S, respectively, continuation was 84% and 68% (p.002) with expulsions in 5.0% and 12.0% (p.05) and removal for pain/bleeding in 3.5% and 17.0% (p.01). At the 24-month visit for VC175 and T380S, respectively, continuation was 77% and 62% (p.02 by log-rank). One ectopic pregnancy was identified at the 12-month follow-up in a VC175 user. No other pregnancies were diagnosed. With 297.3 and 132.4 woman-years, pregnancy rates were 0.3 and 0.0 per 100 woman-years for VC175 and T380S, respectively.VC175 resulted in less pain at insertion, fewer expulsions and higher total continuation than the T380S, with similar contraceptive efficacy.VC175 is a promising new intrauterine copper contraceptive on a nitinol frame that warrants further clinical trials. |
Databáze: | OpenAIRE |
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