RBR-7gqgjm Acceptability and continued use of the contraceptive implant (Implanon) compared to others contraceptive methods in the...

Date of registration: 04/24/2019 ^(mm/dd/yyyy)
Last approval date : 09/29/2023 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1227-8005

• Public title:

  en

  Acceptability and continued use of the contraceptive implant (Implanon) compared to others contraceptive methods in the Brazilian public sector

  pt-br

  Aceitabilidade e continuação de uso do implante contraceptivo (Implanon) comparado a outros contraceptivos no setor público Brasileiro

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 3.092.336
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Estadual de Campinas
  • 00340818.7.0000.5404
    Issuing authority: Plataforma Brasil

Sponsors

• Primary sponsor: Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
• Secondary sponsor:
  • Institution: Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
• Supporting source:
  • Institution: Merck Sharp Dohme do Brasil

Health conditions

• Health conditions:

  en

  Contraception

  pt-br

  Anticoncepção

  es

  Anticoncepción

• General descriptors for health conditions:

  en

  Z00-Z99 XXI - Factors influencing health status and contact with health services

  pt-br

  Z00-Z99 XXI - Fatores que influenciam o estado de saúde e o contato com os serviços de saúde

  es

  Z00-Z99 XXI - Factores que influencian el estado de salud y el contacto con los servicios de salud

• Specific descriptors:

  en

  E02.875.194 Contraception

  pt-br

  E02.875.194 Anticoncepção

  es

  E02.875.194 Anticoncepción

Interventions

• Interventions:

  en

  A total of 955 women will participate on the study, and 351 in the group of implant, 254 in the group of short acting reversible methods (oral contraceptives, injectables and vaginal ring), 175 in the group of the LNG-IUD and 175 in the group of copper-IUD. The women must be recruited among those who were looking for contraceptive methods at the Family Planning clinic of the CAISM-UNICAMP. All the women must be informed and guidance about all the contraceptive methods available at the Family Planning clinic of the CAISM-UNICAM. All the women who choose some of the aforementioned contraceptives will be counseled to maintain a contact with the clinic if they suffer any complaints. Return must be programmed every six months and up to two years after start of the study. Reasons for removal of the method must be obtained from all the women who reported early discontinuation.

  pt-br

  Um total de 955 mulheres participarão do estudo, sendo 351 no grupo do implante, 254 no grupo de métodos de curta duração (pílulas contraceptivas, injetáveis e anel vaginal), 175 no grupo de SIU-LNG e 175 no grupo de DIU com cobre. As mulheres do estudo serão recrutadas entre aquelas que procuram métodos contraceptivos no Ambulatório de Planejamento Familiar do CAISMUNICAMP. Todas as mulheres receberão orientações e informações sobre os métodos contraceptivos disponíveis no Ambulatório de Planejamento Familiar do CAISM-UNICAMP. Todas as mulheres que escolherem alguns dos métodos descritos acima serão instruídas a manter um contato com o ambulatório em caso de qualquer queixa. Serão programados retornos ao ambulatório a cada 6 meses e até dois anos após o início do uso do métodos. As razões de remoção do método serão obtidas de todas as mulheres que apresentaram interrupção precoce.

  es

  Un total de 955 mujeres participarán del estudio, siendo 351 en el grupo do implante, 254 en el grupo de métodos de corta duración (píldoras anticonceptivas, inyectables y anillo), 175 en el grupo de SIU-LNG y 175 en el grupo de DIU con cobre. Las mujeres del estudio serán reclutadas entre aquellas que procuran métodos anticonceptivos en el Ambulatorio de Planificación Familiar del CAISMUNICAMP. Todas las mujeres recibirán orientaciones e informaciones sobre los métodos anticonceptivos disponibles en el Ambulatorio de Planificación Familiar del CAISM-UNICAMP. Todas las mujeres que escojan algún de los métodos descriptos anterioirmente serán instruídas a mantener contacto con el ambulatorio en caso de cualquier queja. Serán programados retornos al ambulatorio a cada 6 meses y hasta dos años posteriores al inicio del uso de los métodos. Las razones de retirada del método serán obtenidas de todas las mujeres que interrumpan precozmente.

• Descriptors:

  en

  Z30.1 Insertion of (intrauterine) contraceptive device

  pt-br

  Z30.1 Inserção de dispositivo anticoncepcional (intra-uterino)

  es

  Z30.1 Inserción de dispositivo anticonceptivo (intrauterino)

  en

  Z30.0 General counselling and advice on contraception

  pt-br

  Z30.0 Aconselhamento geral sobre contracepção

  es

  Z30.0 Consejo y asesoramiento general sobre la anticoncepción

  en

  Z30.4 Surveillance of contraceptive drugs

  pt-br

  Z30.4 Supervisão do uso de medicamentos anticoncepcionais

  es

  Z30.4 Supervisión del uso de drogas anticonceptivas

  en

  Z30.5 Surveillance of (intrauterine) contraceptive device

  pt-br

  Z30.5 Supervisão de dispositivo anticoncepcional (intra-uterino)

  es

  Z30.5 Supervisión del uso de dispositivo anticonceptivo (intrauterino)

Recruitment

• Study status: Terminated
• Countries
  • Brazil
• Date first enrollment: 07/04/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  955	F	18 Y	40 Y

• Inclusion criteria:

  en

  Women between the ages of 18 and 40; Literacy; New Implanon acceptors; TCu380A IUDs; SIU-LNG and short-term methods like combined pill, injectable and vaginal ring

  pt-br

  Mulheres de 18 a 40 anos; Alfabetizadas; Novas aceitantes de Implanon; DIU TCu380A; SIU-LNG e métodos de curta duração com pílula combinada, injetáveis e anel vaginal

  es

  Mujeres de 18 a 40 años; Alfabetizadas; Nuevas aceptantes de Implanon; DIU TCu380A; SIU-LNG y métodos de corta duración como píldora combinada, inyjectábles y anillo vaginal

• Exclusion criteria:

  en

  history of tromboembolism; uterine malformations; blood hipertension; diabetes

  pt-br

  historia de tromboembolismo; malformações uterinas; hipertensão arterial; diabetes

  es

  historia de tromboembolismo; malformaciones uterinas; hipertensión arterial; diabetes

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Other	N/A	0	N/A	N/A	N/A

Outcomes

• Primary outcomes:

  en

  Expected outcome 1: Acceptability of the LNG-IUS and the Implanon when offered as a free choice and without cost to women in the public sector must be higher than the TCu380A IUD: almost of the 70% of new contraceptives available at the Outpatient clinic will be choose a LNG-IUS and Implanon, whereas 30% of women will choose TCu380A IUD; and could be higher when compared to those who choose short acting reversible contraceptive methods (oral contraceptives, injectables, and vaginal ring) (70% vs. 40%)

  pt-br

  Desfecho esperado 1: A aceitabilidade do SIU-LNG e do Implanon quando oferecido como opção livre e sem custos para as mulheres no setor público serão maior que para o DIU TCu380A: quase 70% de usuárias de novos métodos contraceptivos disponíveis no Ambulatório virão a escolher o SIU-LNG e o Implanon, sendo que 30% o DIU TCu380A; e será maior que aquelas que escolherem os métodos de curta duração (pílula combinada, injetáveis e anel vaginal) (70% vs. 40%)

  es

  Resultado esperado 1: La aceptabilidad del SIU-LNG y del Implanon cuando ofrecido como opción libre y sin costos para las mujeres en el sector público será mayor que para los DIU TCu380A: casi 70% de usuarias de nuevos métodos anticonceptivos disponibles em la Clínica van a escoger SIU-LNG e/o Implanon, siendo que 30% van a escoger el DIU TCu380A; y será mayor que aquellas que escojan los métodos de corta duración (píldora combinada, inyectables y anillo vaginal) (70% vs. 40%)

  en

  Outcome observed1: We enrolled a total of 609 women. A total of 358/609 women (58.8%) choose the ENG-implant and 251/609 (41.2%) choose SARC methods.

  pt-br

  Desfecho encontrado 1: Incorporamos um total de 609 mulheres. Um total de 358/609 mulheres (58,8%) escolheram o implante com ENG e 251/609 (41,2%) escolheram métodos de curta duração.

  es

  Resultado encontrado 1: Incorporamos un total de 609 mujeres. Un total de 358/609 mujeres (58,8%) escogieran el implante con ENG y 251/609 (41,2%) escogieran métodos de corta duración.

• Secondary outcomes:

  en

  Expected outcome 2: The continuation rate of the LNG-IUS, Implanon and TCu 380ª IUD, when offered as free choice and without cost to women at the public sector, may be similar: almost 80% of continuation up to the first year and 60% up to the second year; and must be higher when compared to those who choose SARC methods (oral contraceptives, injectables, and vaginal ring) (80% vs. 40%)

  pt-br

  Desfecho esperado 2: A taxa de continuação do SIU-LNG, Implanon e DIU TCu 380A, quando oferecido como opção livre e sem custos para as mulheres no setor público, serão semelhantes: quase 80% de continuação no fim do primeiro ano, 70% no fim do segundo ano e 60% no fim do segundo ano; e será maior que aquelas que escolherem os métodos de curta duração (pílula combinada, injetáveis e anel vaginal) (80% vs. 40%)

  es

  Resultado esperado 2: La tasa de continuación del SIU-LNG, Implanon y DIU TCu 380A, cuando ofrecido como opción libre y sin costos para las mujeres en el sector público, serán semejantes: casi 80% de continuación al fin del primer año y 60% al fin del segundo año; y será mayor que aquellas que escogieron los métodos de corta duración (píldora combinada, inyectables y anillo vaginal) (80% vs. 40%)

  en

  Outcome observed 2: We observed a peak of discontinuation of the ENG-implant users at month 15 of the study whereas among users of the SARC methods the high discontinuation occurs at months 3 and 6. Continuation rate was higher among users of the ENG-implant (89.9% [322/358] and 75.4% [270/358]) when compared to users of SARC methods (27.2% [69/251] and 15.9% [40/251]) up to one and two years after the study initiation, respectively.

  pt-br

  Desfecho encontrado 2: Observamos um pico de descontinuação das usuárias do implante com ENG no mês 15 do estudo, entretanto, entre as usuárias dos métodos de curta duração o pico maior de descontinuação ocorreu nos meses 3 e 6. A taxa de continuação foi maior entre as usuárias do implante com ENG (89.9% [322/358] e 75.4% [270/358]) quando comparada com usuárias de dos métodos de curta duração (27.2% [69/251] e 15.9% [40/251]) no fim do primeiro e segundo ano após início do estudo, respectivamente.

  es

  Resultado encontrado 2: Observamos un pico de descontinuación de las usuarias del implante con ENG em el mes 15 del estudio, sin embargo, entre las usuarias de los métodos de corta duración el mayor pico de descontinuación ocurrió a los meses 3 y 6. La tasa de continuación fue mayor entre las usuarias del implante con ENG (89.9% [322/358] y 75.4% [270/358]) cuando comparada con usuarias de los métodos de corta duración (27.2% [69/251] y 15.9% [40/251]) al fin del primer y segundo año posteriores al inicio del estudio, respectivamente.

  en

  Expected outcome 3: The main reasons for removal for each intrauterine method must be irregular bleeding, pain and expulsion, whereas for Implanon the main reason of discontinuation must be irregular bleeding;

  pt-br

  Desfecho esperado 3: As principais razões de remoção para cada um dos dois métodos intrauterinos será sangramento irregular, dor e expulsão, sendo que para o Implanon a principal razão de descontinuidade será sangramento irregular;

  es

  Resultado esperado 3: Las principales razones de remoción para cada uno de los dos métodos intrauterinos será sangrado irregular, dolor y expulsión, siendo que para el Implanon la principal razón de discontinuidad será sangrado irregular;

  en

  Outcome observed 3: The main reasons for discontinuation among users of the LNG-IUS and the TCu380A IUD were irregular bleeding, pain and expulsion whereas for the Implanon the main reason for discontinuation was irregular bleeding;

  pt-br

  Desfecho encontrado 3: As principais razões de remoção para o SIU-LNG e o DIU com cobre TCu380A foram o sangramento irregular, dor e expulsão sendo que para o Implanon a principal razão descontinuidade foi o sangramento irregular;

  es

  Resultado encontrado 3: Las principales razones de remoción para el SIU-LNG y el DIU con cobre TCu380A fueron el sangrado irregular, dolor y expulsión, siendo que para el Implanon la principal razón de discontinuidad fue el sangrado irregular;

  en

  Expected outcome 4: The main reason of discontinuation of the SARC methods (combined oral contraceptives, injectables and vaginal ring) may be irregular bleeding, dizziness, pain and abdominal pain

  pt-br

  Desfecho esperado 4: As principais razões de interrupção dos métodos de curta duração (pílula combinada, injetáveis e anel vaginal) será sangramento irregular, náusea, dor em baixo ventre;

  es

  Resultado esperado 4: Las principales razones de interrupción de uso de los métodos de corta duración (píldora combinada, inyectables y anillo vaginal) será sangrado irregular, náusea, dolor en bajo vientre;

  en

  Outcome observed 4: The main reason of discontinuation of the SARC methods (combined oral contraceptives, injectables and vaginal ring) were irregular bleeding, dizziness, pain and abdominal pain, and acne;

  pt-br

  Desfecho encontrado 4: As principais razões de interrupção dos métodos de curta duração (pílula combinada, injetáveis e anel vaginal) foram sangramento irregular, náusea, dor em baixo ventre e acne;

  es

  Resultado encontrado 4: Las principales razones de interrupción de uso de los métodos de corta duración (píldora combinada, inyectables y anillo vaginal) fueran sangrado irregular, náusea, dolor en bajo vientre y acné

  en

  Expected outcome 5: The women´s groups must be satisfied with the chosen contraceptive in a proportion of 80% for the LARCs and 60% for the SARC methods.

  pt-br

  Desfecho esperado 5: Os grupos de mulheres estarão satisfeitas com o método escolhido em uma proporção de 80% para LARC e 60% para métodos de curta duração.

  es

  Resultado esperado 5: Los grupos de mujeres estarán satisfechas con el método escogido en una proporción de 80% para LARC y 60% para métodos de corta duración.

  en

  Outcome observed 5: Satisfaction was high in both group of users; however, users of the ENG-implant reported satisfaction rate of 83.2% and 82.2% when compared to 92.8% and 88.9% among users of the SARC methods up to one and two years after study initiation.

  pt-br

  Desfecho encontrado 5: Satisfação foi alta em ambos os grupos de usuárias; entretanto, usuárias de implante com ENG informaram taxa de satisfação de 83.2% e 82.2% quando comparadas com 92.8% e 88.9% entre usuárias de métodos de curta duração até um e dois anos pós início do estudo.

  es

  Resultado encontrado 5: Satisfacción fue alta en ambos grupos de usuarias; sin embargo las usuarias de implante con ENG informaron tasas de satisfacción de 83.2% y 82.2% cuando comparadas con 92.8% y 88.9% entre usuarias de métodos de corta duración hasta uno y dos años posteriores al inicio del estudio.

Summary Results

• Date posted: 07/10/2023 ^(mm/dd/yyyy)

• Baseline char:

  en

  Women aged between 18 and 43 years were recruted for both groups. Group 1: SARC (Short acting reversible contraceptives).
  Group 2: LARC (Long acting reversible contraceptives)

• Participants flow:

  en

  A total of 1222 women were recruited in the study and allocated in two groups: Group 1: SARCS, n: 251 (165 patch, 47 vaginal ring, 22 monthly injectables and 17 oral contraceptives); Grupo 2: LARCS, n: 971 (414 Hormonal IUD, 358 Implanon-NXT and 199 IUD TCu380A). 453 women discontinued; 211 from group SARCS and 242 from group LARCS. However, 769 women concluded the study; 40 from group SARC and 729 from group LARC.

• Adverse events:

  en

  1) Among users of SARC, the adverse events were: dizziness and vomit (12), pelvic pain (8), abnormal bleeding (7) and pregnancy (3); 2) Among users of hormonal IUD, the adverse events were: expulsion (24), abnormal bleeding (17) and pelvic pain (12); 3) Among users of Implanon-NXT, the adverse events were: abnormal bleeding (47), weight gain (6), pelvic pain (5) and pregnancy (2); 4) Among users of IUD TCu380A, the adverse events were: expulsion (30), abnormal bleeding (20) and pregnancy (2).

• Outcome measure:

  en

  Primary Outcome: Aceitability rates, [p-value <0.001]. Group 1: SARC, 251/1222 (20.5%). Group 2: LARC, 971/ 1222 (79.5%). Secondary Outcome: Discontinuity rate, [p-value <0.001]. Group 1: SARC, 211/251 (84.1%). Group 2: LARC, 242/971 (24.9%). Satisfaction rate. Group 1: SARC (88.9%). Group 2: LARC (86.1%)

• Results summary:

  en

  Introduction: Long-acting reversible contraceptives (LARC), including the copper-bearing intrauterine device (IUD) (TCu380A), the levonorgestrel-releasing intrauterine system (LNG-IUS), and the etonogestrel-releasing subdermal implant (ENG), are the most effective reversible contraceptives, with the advantage of being convenient and highly desired by users, low cost and requiring a single action to start use. These characteristics compare favorably with other short-acting methods (SARC) that include: combined pills, injectables or vaginal rings that depend on the user, which increases the risk of method failure. Due to the lack of studies comparing LARC and SARC in Brazil, we carried out this study with the following objectives. Objectives: To compare the acceptability rate and discontinuation rates between the etonogestrel (ENG)-releasing implant (Implanon), copper intrauterine device (TCu380A IUD), the levonorgestrel-releasing intrauterine system (LNG-IUS) and short-term methods up to two years after insertion. Methods: We carried out a prospective cohort study at the University of Campinas, SP, Brazil. The study was approved by the university ethics committee (CAAE: 00340818.7.0000.5404). We included women aged 18 to 43 who attended the family planning clinic looking for a contraceptive method between July 2019 and August 2020. All women received counseling about different contraceptive methods and signed a consent form. Additionally, participants were followed up every 3 months until 24 months after insertion. Satisfaction and reasons for discontinuation were assessed. The Kaplan-Meier test was used for survival analysis and the log-rank test for curve comparisons. The significance level was 5%. Results: We included 1222 women in the study, 251 in the SARC group (patches, 165; vaginal ring, 47; monthly injectables, 22; and birth control pills, 17) and 971 in the LARC group (LNG-IUS, 414; implant, 358; and IUD copper, 199). Up to two years, 211/251 (84.1%) discontinued in the SARC group and 242/971 (24.9%) in the LARC group. Among LARC users, there was a significantly greater difference in discontinuation rate for the copper IUD, 80/199 (40.2%) compared to the implant 88/358 (24.6%) and the LNG-IUD 74/ 414 (17.9%); [p<0.001]. Personal reasons were the main reason for discontinuation among SARC users. Abnormal uterine bleeding (AUB) as a cause for discontinuation was higher among ENG implant and TCu380A IUD users, and expulsion was significantly higher for the TCu380A IUD compared with the 52 mg levonorgestrel IUD. The pregnancy rate was 1.2% in the SARC group and for LARC it ranged from 0.5% to 1.0% for the implant and the TCu380A IUD, respectively. Satisfaction rates were high in the SARC (88.9%) and LARC (86.1%) groups. Conclusion When LARC and SARC were offered free of charge, there was greater uptake of LARC and a lower dropout rate than SARC. Both groups had high levels of satisfaction.

Data Sharing Plan

• Data Sharing Plan:

  en

  No

Contacts

• Public contact
  • Full name: Luis Guillermo Bahamondes
  • • Address: Rua Vital Brasil, 200 Cidade Universitária 2o andar
    • City: Campinas / Brazil
    • Zip code: 13083-888
  • Phone: +55(19)32892856
  • Email: bahamond@caism.unicamp.br
  • Affiliation: Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
  • Full name: Adriana Barros de Pedro Costa
  • • Address: Rua Vital Brasil, 200
    • City: Campinas / Brazil
    • Zip code: 13083888
  • Phone: +55(19)32892856
  • Email: abarros@cemicamp.org.br
  • Affiliation: Centro de Pesquisa em Saúde Reprodutiva de Campinas
   
• Scientific contact
  • Full name: Luis Guillermo Bahamondes
  • • Address: Rua Vital Brasil, 200 Cidade Universitária 2o andar
    • City: Campinas / Brazil
    • Zip code: 13083-888
  • Phone: +55(19)32892856
  • Email: bahamond@caism.unicamp.br
  • Affiliation: Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher - CAISM/ Unicamp
   
• Site contact
   

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