Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial.

BACKGROUND: The etonogestrel (ENG) implant Implanon is a progestin-only contraceptive that provides effective contraception for up to 3 years. A new radiopaque ENG implant has been developed to extend the diagnostic modalities of Implanon and a next-generation applicator (NGA) was designed to facilitate correct subdermal insertion of Implanon. STUDY DESIGN: In this open-label study, 23 investigators, experienced and inexperienced with Implanon, performed 301 insertions of the new radiopaque implant using the NGA. Primary outcome measurements were obtained from clinician satisfaction questionnaires completed after the 4th, 8th and 12th insertions. Additionally, insertion characteristics and X-ray visibility were assessed. RESULTS: Almost all investigators were satisfied with the NGA from the first insertion onward, and all were satisfied or very satisfied after 12 insertions. The most frequently reported advantages included ease of use, one-handed action and fast insertion time; 2% of insertions were considered difficult in skin puncturing and/or sliding the needle subdermally. Three incorrect insertions occurred due to noncompliance with instructions. All assessed implants were visible on plain X-ray imaging. CONCLUSIONS: The NGA was well accepted by investigators with or without prior experience with Implanon. The results stressed the importance of correctly following implant insertion instructions.

Enterovirus RNA shedding in the genital tract of childbearing-aged women living in Central Africa.

Enteroviruses (EVs) (Picornaviridae) in the female genital tract may constitute possible sources of antenatal or perinatal infection. The presence of EV genomes in the acellular part of cervicovaginal lavages of 119 non-pregnant childbearing-aged African women was determined using a semiquantitative RT-PCR and hybridization detection assay. EV-specific cervicovaginal IgA and IgG antibodies were also detected by immunocapture ELISA assays. Of 119 CVS samples tested, only 10 (8%) were positive for the detection of EV RNA, demonstrating an genital shedding of EVs in African woman. EV-RNA positivity was not associated with the HIV serostatus or with the presence of semen traces in female genital secretion. The microwell hybridization assay of EV amplified RT-PCR products indicated the presence of low levels of EV genomes, ranging from 50 to 100 RNA copies per ml of genital fluids. EV-specific cervicovaginal IgA or IgG antibodies were detected only in two hemoglobin-positive cervicovaginal secretions samples from women without genital EVs. The lack of EV specific IgA or IgG antibody secretion by the cervicovaginal mucosa supported the hypothesis of genital shedding of EVs without ongoing viral replication in the female genital tract. In conclusion, the findings demonstrated the presence of EV genomes in nearly 10% of childbearing-aged women living in Central Africa, and provided the basis of possible antenatal or perinatal transmission of EV from mother-to-child.