Carolina Sales Vieira1, Mariane Nunes de Nadai2, Lilian Sheila de Melo Pereira do Carmo2, Giordana Campos Braga2, Bruna Fregonesi Infante3, Bianca M Stifani4, Rui Alberto Ferriani2, Silvana Maria Quintana5. 1. Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil. Electronic address: carol.sales@uol.com.br. 2. Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil. 3. Women' s Health Reference Center of Ribeirão Preto. Avenida Wanderley Taffo, 330 Quintino Facci II, CEP: 14070-000, Ribeirão Preto, SP, Brazil. 4. Department of Obstetrics, Gynecology and Women's Health of Albert Einstein College of Medicine / Montefiore Medical Center, 1300 Morris Park Avenue, Bronx, NY, 10461, USA. 5. Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil; Women' s Health Reference Center of Ribeirão Preto. Avenida Wanderley Taffo, 330 Quintino Facci II, CEP: 14070-000, Ribeirão Preto, SP, Brazil.
Abstract
OBJECTIVES: To evaluate whether timing of etonogestrel (ENG) implant insertion during the postpartum period affects maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates. STUDY DESIGN: This is a secondary analysis of an open, randomized, controlled trial. Postpartum women were block-randomized to early (up to 48 h postpartum) or delayed (6 weeks postpartum) insertion of an ENG implant. Bleeding patterns and BMI were evaluated every 90 days for 12 months. At 12 months, we measured implant continuation rates and used Likert and face scales to measure users' satisfaction. The level of significance was 0.4% (adjusted by Bonferroni test for multiplicity). RESULTS:We enrolled 100 postpartum women; we randomized 50 to early and 50 to delayed postpartum ENG implant insertion. Bleeding patterns were similar between groups. Amenorrhea rates were high in both groups during the follow-up (52%-56% and 46%-62% in the early and delayed insertion group, respectively). Prolonged bleeding episodes were unusual in both groups during the follow-up (0-2%). Maternal BMI was similar between groups and decreased over time. Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99). Most participants were either very satisfied or satisfied with the ENG implant in both groups (p=.9). CONCLUSION: Women who underwent immediate postpartum insertion of the ENG implant have similar bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates compared to those who underwent delayed insertion. IMPLICATIONS: Our results from a secondary analysis of a clinical trial support that satisfaction, continuation and bleeding patterns do not differ when women received contraceptive implants immediately postpartum or at 6 weeks. However, the emphasis on infant growth in the trial and easy access to delayed placement may have influenced results.
RCT Entities:
OBJECTIVES: To evaluate whether timing of etonogestrel (ENG) implant insertion during the postpartum period affects maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates. STUDY DESIGN: This is a secondary analysis of an open, randomized, controlled trial. Postpartum women were block-randomized to early (up to 48 h postpartum) or delayed (6 weeks postpartum) insertion of an ENG implant. Bleeding patterns and BMI were evaluated every 90 days for 12 months. At 12 months, we measured implant continuation rates and used Likert and face scales to measure users' satisfaction. The level of significance was 0.4% (adjusted by Bonferroni test for multiplicity). RESULTS: We enrolled 100 postpartum women; we randomized 50 to early and 50 to delayed postpartum ENG implant insertion. Bleeding patterns were similar between groups. Amenorrhea rates were high in both groups during the follow-up (52%-56% and 46%-62% in the early and delayed insertion group, respectively). Prolonged bleeding episodes were unusual in both groups during the follow-up (0-2%). Maternal BMI was similar between groups and decreased over time. Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99). Most participants were either very satisfied or satisfied with the ENG implant in both groups (p=.9). CONCLUSION:Women who underwent immediate postpartum insertion of the ENG implant have similar bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates compared to those who underwent delayed insertion. IMPLICATIONS: Our results from a secondary analysis of a clinical trial support that satisfaction, continuation and bleeding patterns do not differ when women received contraceptive implants immediately postpartum or at 6 weeks. However, the emphasis on infant growth in the trial and easy access to delayed placement may have influenced results.