Immediate postpartum insertion of the etonogestrel-releasing implant and bleeding pattern during 1-year of follow-up: a randomized controlled trial
ESC Congress Library. Vieira C.
May 10, 2018; 208204
Disclosure(s): CSV has served on the Medical Advisory Boards for Merck and Bayer, and has given ad hoc invited lectures for Merck and Bayer.
Prof. Dr. Carolina Vieira
Prof. Dr. Carolina Vieira
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Abstract
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Objective: This study aimed to evaluate if the timing of insertion of the etonogestrel (ENG) implant during the postpartum period affects bleeding patterns. We also evaluated user satisfaction and continuation rates for different times of postpartum ENG insertion.   Design and Methods: An open, randomized, controlled, and parallel trial was conducted in a low-risk maternity ward at the University Hospital of Ribeirão Preto School of Medicine, Brazil. Postpartum women were block-randomized (1:1) to early (up to 48 hours postpartum and before hospital discharge) or conventional (at 6 weeks postpartum) insertion of an ENG implant. The follow-up period was 12 months. Bleeding patterns were evaluated using a daily paper diary; these were then summarized for each 90-day reference period (RP) and classified according to the World Health Organization terminology. We measured implant continuation rates at 12 months regardless of trial continuation rates by contacting participants by phone. We used Likert and face scales to measure user satisfaction. We used Chi-square and Fisher's exact test to analyze the outcomes; the level of significance was set at 5%. Results: a total of 100 postpartum women were enrolled, of whom 50 were randomized to early ENG implant insertion and 50 to conventional postpartum insertion. Sociodemographic characteristics were similar between groups, except for educational attainment, as the conventional insertion group had a higher proportion of women with 8 or more years of education than the early insertion group (88% compared with 70%, p=0.02). There were no differences in the bleeding patterns between the groups in all RPs evaluated, with high rates of amenorrhea and low rates of prolonged bleeding. In the first RP (0-3 months), amenorrhea rates were 58.5% and 62% (p=0.22) in the early and conventional groups, respectively, and no participant presented with prolonged bleeding. In the last RP (9-12 months), amenorrhea rates were 59.1% and 56.1% (p=0.55) in the early and conventional groups, respectively, and 2% of participants in each group presented prolonged bleeding in both groups. Twelve-month continuation rates were similar between groups [early insertion= 98% (49/50) vs. conventional insertion= 100% (50/50), p=0.3]. Satisfaction was high in both groups (more than 91% of the sample considered themselves either very satisfied or satisfied with the ENG-implant use), without difference between groups. Conclusion: Women who underwent immediate postpartum insertion of the ENG implant did not have different bleeding patterns, satisfaction and continuation rates compared to women who underwent ENG implant insertion at six weeks postpartum. 
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