(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: american journal of obstetrics and gynecology (2005) 192, 1989¿94; doi:10.1016/j.Ajog.2005.02.127.(b)(4).
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It was reported via journal article: title: "transvaginal placement of cervicoisthmic cerclage: report on pregnancy outcome." author(s): michael katz, md, carol abrahams, ms.Citation: american journal of obstetrics and gynecology (2005) 192, 1989¿94; doi:10.1016/j.Ajog.2005.02.127.This retrospective analysis was conducted to describe the pregnancy outcome for a large number of patients who had a transvaginal cervicoisthmic cerclage.Over a 10-year period, from 1992 to 2002, 53 pregnant women underwent surgery for transvaginal placement of a cerclage at the level of the cervicoisthmic junction between 12 and 17 weeks of gestation.In the procedure, a 5-mm mersilene tape was threaded very superficially, flat, through the tissue at anterior surface of the cervicoisthmic junction.One patient had her suture removed because of dyspareunia and vaginal discharge.Procedure-related complication included intrapartum cervical tear due to incomplete removal before labor (n=1); hematoma (<50ml) between bladder and cervix (n=1) that needed to be evacuated; and transient urinary retention with pelvic pain (n=2).Other postoperative complications included admission for removal of postcerclage hematoma (n=1); lower abdominal pain (n=1); and chorioamnionitis (n=2).The placement of transvaginal cervicoisthmic cerclage was associated with favorable pregnancy outcome and may be considered as a suitable safe alternative to the transabdominal cerclage.
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