Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/353946
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dc.contributor.CRUESPUNIVERSIDADE ESTADUAL DE CAMPINASpt_BR
dc.contributor.authorunicampMakuch, Maria Valeria Bahamondes-
dc.contributor.authorunicampEspejo-Arce, Ximena-
dc.contributor.authorunicampBahamondes, Luis Guillermo-
dc.typeArtigopt_BR
dc.titleEffect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCTpt_BR
dc.contributor.authorBahamondes, M. Valeria-
dc.contributor.authorEspejo-Arce, Ximena-
dc.contributor.authorBahamondes, Luis-
dc.subjectMisoprostolpt_BR
dc.subjectAnticoncepcionaispt_BR
dc.subject.otherlanguageMisoprostolpt_BR
dc.subject.otherlanguageContraceptivept_BR
dc.description.abstractStudy question: Is pretreatment with misoprostol useful in insertion of intrauterine contraceptives (IUCs) after insertion failure at the first attempt? Summary answer: Pretreatment with intravaginal administration of 200 mcg of misoprostol after IUC insertion failure 10 and 4 h before the second attempt of IUC placement was significantly better than placebo at facilitating the insertion of an IUC. What is known already: One of the reasons for low use of IUCs is the concept that insertion is difficult. Misoprostol was used in several randomized clinical trials (RCT) before IUC insertion to facilitate the insertion. In general, the results showed no significant differences when compared with placebo. However, most previous studies have been carried out among unselected women whereas the present study is among women with previous insertion failure. Study design, size, duration: This was a double blind RCT conducted between February 2013 and October 2014. Participants were 104 women who requested an insertion of an IUC and the insertion failed at the first attempt. After insertion failure, the women received a sealed envelope with misoprostol or placebo. The randomization system (1: 1) in one block size was computer-generated. Participants/materials, setting, methods: The study was conducted at a tertiary care centre. The women were instructed to insert vaginally one tablet of misoprostol 200 µg (Prostokos, Hebron, Cariacica, PE, Brazil) or placebo 10 and 4 h before the woman returned to the clinic for a new insertion attempt. The outcomes were successful IUC insertion and the use of a cervical dilator immediately prior to the insertion procedure. Main results and the role of change: A total of 2639 women requested the insertion of an IUC during the study period. The IUC was inserted at the first attempt in 2535 women (96%) and 104 women in whom we were unable to insert the device were eligible to participate in the RCT. Four women declined and 100 women were randomized (55 for the misoprostol group and 45 for the placebo group). From the 100 participating women, the levonorgestrel-releasing intrauterine system (LNG-IUS) was chosen by 55 and 37 women and the TCu380A intrauterine device (Cu-IUD) was chosen by none and 8 women in the misoprostol and placebo group, respectively. Seven and three women allocated to misoprostol and placebo, respectively, never returned to the clinic after randomization. We placed the IUC in 42 (87.5%) out of the 48 women and in 26 (61.9%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.0066). Regarding the Evaluable Population the relative risk (RR) of successful insertions was 1.41 (95% confidence interval (CI) for absolute difference (8.2, 43.0), P = 0.0066); in the Intent-to-Treat Population the RR (95% CI) was 1.32 (0.3, 36.9). Multiple regression analysis showed that the significant variables associated with the insertion failure were the number of Caesarean section ≥1 (P = 0.020) and the use of placebo (P = 0.026). Dilators were used in 21 (43.7%) out of the 48 and 21 (50%) out of the 42 women randomized to misoprostol and placebo, respectively (P = 0.804). Limitations, reasons for caution: The limitations were that the majority of the women chose the LNG-IUS, and consequently the data for the Cu-IUD were limited, and there was a small number of nulligravidas. Wider implications of the findings: The results show that IUC insertion difficulties and failures are not common. Pretreatment with intravaginal misoprostol facilitated IUC insertion after failure of insertion at the first attempt, and insertion failure was associated with number of Caesarean sections. Study funding/competing interest(s): This study received partial financial support from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), grant # 2012/10085-0, and from the National Research Council (CNPq), grant #573747/2008-3. All the TCu380A IUDs were donated by Injeflex, São Paulo, Brazil, and all the LNG-IUS were donated by the International Contraceptive Access Foundation (ICA), Turku, Finland. Both donations were provided in the form of unrestricted grants. The authors declare that there are no conflicts of interest associated with this study.pt_BR
dc.relation.ispartofHuman reproductionpt_BR
dc.relation.ispartofabbreviationHum. reprod.pt_BR
dc.publisher.cityOxfordpt_BR
dc.publisher.countryReino Unidopt_BR
dc.publisherOxford University Presspt_BR
dc.date.issued2015-
dc.date.monthofcirculationAug.pt_BR
dc.language.isoengpt_BR
dc.description.volume30pt_BR
dc.description.issuenumber8pt_BR
dc.description.firstpage1861pt_BR
dc.description.lastpage1866pt_BR
dc.rightsFechadopt_BR
dc.sourceWOSpt_BR
dc.identifier.issn0268-1161pt_BR
dc.identifier.eissn1460-2350pt_BR
dc.identifier.doi10.1093/humrep/dev137pt_BR
dc.identifier.urlhttps://academic.oup.com/humrep/article/30/8/1861/951174pt_BR
dc.description.sponsorshipCONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - CNPQpt_BR
dc.description.sponsorshipFUNDAÇÃO DE AMPARO À PESQUISA DO ESTADO DE SÃO PAULO - FAPESPpt_BR
dc.description.sponsordocumentnumber573747/2008-3pt_BR
dc.description.sponsordocumentnumber2012/10085-0pt_BR
dc.date.available2021-01-14T13:54:32Z-
dc.date.accessioned2021-01-14T13:54:32Z-
dc.description.provenanceSubmitted by Bruna Maria Campos da Cunha (bcampos@unicamp.br) on 2021-01-14T13:54:32Z No. of bitstreams: 0. Added 1 bitstream(s) on 2021-02-19T18:01:55Z : No. of bitstreams: 1 000359743300014.pdf: 318936 bytes, checksum: 0a2c4cd5a9492a2ad97e475fbd81329b (MD5)en
dc.description.provenanceMade available in DSpace on 2021-01-14T13:54:32Z (GMT). No. of bitstreams: 0 Previous issue date: 2015en
dc.identifier.urihttp://repositorio.unicamp.br/jspui/handle/REPOSIP/353946-
dc.contributor.departmentSem informaçãopt_BR
dc.contributor.departmentSem informaçãopt_BR
dc.contributor.departmentDepartamento de Tocoginecologiapt_BR
dc.contributor.unidadeFaculdade de Ciências Médicaspt_BR
dc.contributor.unidadeFaculdade de Ciências Médicaspt_BR
dc.contributor.unidadeFaculdade de Ciências Médicaspt_BR
dc.subject.keywordInsertion failurept_BR
dc.subject.keywordIntrauterine contraceptivespt_BR
dc.subject.keywordCopper intrauterine devicept_BR
dc.subject.keywordLevonorgestrel-releasing intrauterine systempt_BR
dc.identifier.source000359743300014pt_BR
dc.creator.orcidSem informaçãopt_BR
dc.creator.orcidSem informaçãopt_BR
dc.creator.orcid0000-0002-7356-8428pt_BR
dc.type.formArtigo originalpt_BR
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